Trial Outcomes & Findings for Clinical Trial of a Hydrophilic EMV Toric Lens RAO210T in the Correction of Aphakia and Corneal Astigmatism (NCT NCT05985304)

NCT ID: NCT05985304

Last Updated: 2026-01-21

Results Overview

Mean magnitude of residual manifest cylinder (as measured by manifest refractive cylinder).

Recruitment status

COMPLETED

Study phase

Target enrollment

274 participants

Primary outcome timeframe

120 to 180 days post-operatively

Results posted on

2026-01-21

Participant Flow

Of the 274 enrolled subjects, 32 subjects were screen failures who did not meet the study-specific inclusion/exclusion criteria (32/274, 11.7%), five subjects were withdrawn before randomization (5/274, 1.7%)

Participant milestones

Participant milestones
Measure	Toric (Test) Group All subjects randomized to be implanted with the low cylinder (1.50 D) RayOne EMV Toric IOL (Model RAO210T) RayOne EMV Toric IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts	Monofocal (Control) Group All subjects randomized to be implanted with the RAO600C Monofocal IOL RayOne Monofocal IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts
Overall Study STARTED	118	120
Overall Study COMPLETED	117	116
Overall Study NOT COMPLETED	1	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Toric (Test) Group All subjects randomized to be implanted with the low cylinder (1.50 D) RayOne EMV Toric IOL (Model RAO210T) RayOne EMV Toric IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts	Monofocal (Control) Group All subjects randomized to be implanted with the RAO600C Monofocal IOL RayOne Monofocal IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts
Overall Study Protocol Violation	1	0
Overall Study Withdrawal by Subject	0	2
Overall Study Subject was not implanted with the study device	0	2

Baseline Characteristics

Subjects with a Uncorrected Distance Visual Acuity (UCDVA) measurement of 'Count Fingers' or 'Hand Motion' are excluded from logMAR summaries

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Toric (Test) Group n=118 Participants All subjects randomized to be implanted with the low cylinder (1.50 D) RayOne EMV Toric IOL (Model RAO210T) RayOne EMV Toric IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts	Monofocal (Control) Group n=120 Participants All subjects randomized to be implanted with the RAO600C Monofocal IOL RayOne Monofocal IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts	Total n=238 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=118 Participants	0 Participants n=120 Participants	0 Participants n=238 Participants
Age, Categorical Between 18 and 65 years	36 Participants n=118 Participants	23 Participants n=120 Participants	59 Participants n=238 Participants
Age, Categorical >=65 years	82 Participants n=118 Participants	97 Participants n=120 Participants	179 Participants n=238 Participants
Age, Continuous	67.7 years STANDARD_DEVIATION 7.4 • n=118 Participants	69.4 years STANDARD_DEVIATION 7.0 • n=120 Participants	68.5 years STANDARD_DEVIATION 7.2 • n=238 Participants
Sex: Female, Male Female	66 Participants n=118 Participants	70 Participants n=120 Participants	136 Participants n=238 Participants
Sex: Female, Male Male	52 Participants n=118 Participants	50 Participants n=120 Participants	102 Participants n=238 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=118 Participants	2 Participants n=120 Participants	3 Participants n=238 Participants
Race/Ethnicity, Customized Asian	1 Participants n=118 Participants	0 Participants n=120 Participants	1 Participants n=238 Participants
Race/Ethnicity, Customized Black or African American	4 Participants n=118 Participants	1 Participants n=120 Participants	5 Participants n=238 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=118 Participants	0 Participants n=120 Participants	0 Participants n=238 Participants
Race/Ethnicity, Customized White	112 Participants n=118 Participants	115 Participants n=120 Participants	227 Participants n=238 Participants
Race/Ethnicity, Customized Multiple	0 Participants n=118 Participants	2 Participants n=120 Participants	2 Participants n=238 Participants
Race/Ethnicity, Customized Hispanic or Latino	3 Participants n=118 Participants	4 Participants n=120 Participants	7 Participants n=238 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	115 Participants n=118 Participants	116 Participants n=120 Participants	231 Participants n=238 Participants
Region of Enrollment United States	118 participants n=118 Participants	120 participants n=120 Participants	238 participants n=238 Participants
Study Eye Right Eye (OD)	62 Participants n=118 Participants	73 Participants n=120 Participants	135 Participants n=238 Participants
Study Eye Left Eye (OS)	56 Participants n=118 Participants	47 Participants n=120 Participants	103 Participants n=238 Participants
Axial Length	24.183 mm STANDARD_DEVIATION 1.118 • n=118 Participants	24.120 mm STANDARD_DEVIATION 1.117 • n=120 Participants	24.151 mm STANDARD_DEVIATION 1.116 • n=238 Participants
Anterior Chamber Depth	3.337 mm STANDARD_DEVIATION 0.401 • n=118 Participants	3.247 mm STANDARD_DEVIATION 0.381 • n=120 Participants	3.292 mm STANDARD_DEVIATION 0.393 • n=238 Participants
Uncorrected Distance Visual Acuity (UCDVA)	0.632 logMAR STANDARD_DEVIATION 0.407 • n=116 Participants • Subjects with a Uncorrected Distance Visual Acuity (UCDVA) measurement of 'Count Fingers' or 'Hand Motion' are excluded from logMAR summaries	0.556 logMAR STANDARD_DEVIATION 0.363 • n=116 Participants • Subjects with a Uncorrected Distance Visual Acuity (UCDVA) measurement of 'Count Fingers' or 'Hand Motion' are excluded from logMAR summaries	0.594 logMAR STANDARD_DEVIATION 0.387 • n=232 Participants • Subjects with a Uncorrected Distance Visual Acuity (UCDVA) measurement of 'Count Fingers' or 'Hand Motion' are excluded from logMAR summaries
Best-corrected Distance Visual Acuity (BCDVA) Without Glare	0.183 logMAR STANDARD_DEVIATION 0.159 • n=118 Participants	0.227 logMAR STANDARD_DEVIATION 0.236 • n=120 Participants	0.205 logMAR STANDARD_DEVIATION 0.202 • n=238 Participants
Best-corrected Distance Visual Acuity (BCDVA) with Glare	0.860 logMAR STANDARD_DEVIATION 0.569 • n=87 Participants • Best-corrected Distance Visual Acuity (BCDVA) with Glare was only measured if BCDVA without Glare was better than 0.3 logMAR (20/40 Snellen).	0.866 logMAR STANDARD_DEVIATION 0.536 • n=87 Participants • Best-corrected Distance Visual Acuity (BCDVA) with Glare was only measured if BCDVA without Glare was better than 0.3 logMAR (20/40 Snellen).	0.863 logMAR STANDARD_DEVIATION 0.551 • n=174 Participants • Best-corrected Distance Visual Acuity (BCDVA) with Glare was only measured if BCDVA without Glare was better than 0.3 logMAR (20/40 Snellen).
Keratometric Cylinder	1.206 Diopter STANDARD_DEVIATION 0.146 • n=118 Participants	1.247 Diopter STANDARD_DEVIATION 0.136 • n=120 Participants	1.227 Diopter STANDARD_DEVIATION 0.142 • n=238 Participants
Preoperative Keratometric Cylinder Subgroup 1.0 to <1.25 D	76 Participants n=118 Participants	63 Participants n=120 Participants	139 Participants n=238 Participants
Preoperative Keratometric Cylinder Subgroup 1.25 to 1.5 D	42 Participants n=118 Participants	57 Participants n=120 Participants	99 Participants n=238 Participants
Manifest Refraction Cylinder	-1.121 Diopter STANDARD_DEVIATION 0.726 • n=118 Participants	-1.038 Diopter STANDARD_DEVIATION 0.592 • n=120 Participants	-1.079 Diopter STANDARD_DEVIATION 0.662 • n=238 Participants
Manifest Refraction Spherical Equivalent (MRSE) at 4m	-1.4015 Diopter STANDARD_DEVIATION 2.9906 • n=118 Participants	-0.8896 Diopter STANDARD_DEVIATION 2.7307 • n=120 Participants	-1.1434 Diopter STANDARD_DEVIATION 2.8680 • n=238 Participants
Manifest Refraction Optical Infinity Spherical Equivalent (MROISE)	-1.6472 Diopter STANDARD_DEVIATION 2.9851 • n=118 Participants	-1.1396 Diopter STANDARD_DEVIATION 2.7307 • n=120 Participants	-1.3913 Diopter STANDARD_DEVIATION 2.8649 • n=238 Participants
Target Postoperative (PO) Residual Astigmatism	0.183 Diopter STANDARD_DEVIATION 0.102 • n=117 Participants • One subject did not have a Barrett Toric Calculator entry	0.199 Diopter STANDARD_DEVIATION 0.127 • n=120 Participants • One subject did not have a Barrett Toric Calculator entry	0.191 Diopter STANDARD_DEVIATION 0.115 • n=237 Participants • One subject did not have a Barrett Toric Calculator entry
Intraocular Lens (IOL) Power Spherical Equivalent (SE)	18.10 Diopter STANDARD_DEVIATION 3.29 • n=117 Participants • One subject did not have a Barrett Toric Calculator entry	18.55 Diopter STANDARD_DEVIATION 3.30 • n=120 Participants • One subject did not have a Barrett Toric Calculator entry	18.32 Diopter STANDARD_DEVIATION 3.29 • n=237 Participants • One subject did not have a Barrett Toric Calculator entry
Target Residual Spherical Equivalent (SE)	-0.012 Diopter STANDARD_DEVIATION 0.099 • n=117 Participants • One subject did not have a Barrett Toric Calculator entry	-0.000 Diopter STANDARD_DEVIATION 0.120 • n=120 Participants • One subject did not have a Barrett Toric Calculator entry	-0.006 Diopter STANDARD_DEVIATION 0.110 • n=237 Participants • One subject did not have a Barrett Toric Calculator entry
LOCS III: Nuclear Color NC1	14 Participants n=117 Participants • One subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening	14 Participants n=120 Participants • One subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening	28 Participants n=237 Participants • One subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening
LOCS III: Nuclear Color NC2	35 Participants n=117 Participants • One subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening	40 Participants n=120 Participants • One subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening	75 Participants n=237 Participants • One subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening
LOCS III: Nuclear Color NC3	50 Participants n=117 Participants • One subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening	50 Participants n=120 Participants • One subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening	100 Participants n=237 Participants • One subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening
LOCS III: Nuclear Color NC4	9 Participants n=117 Participants • One subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening	11 Participants n=120 Participants • One subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening	20 Participants n=237 Participants • One subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening
LOCS III: Nuclear Color NC5	8 Participants n=117 Participants • One subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening	2 Participants n=120 Participants • One subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening	10 Participants n=237 Participants • One subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening
LOCS III: Nuclear Color NC6	1 Participants n=117 Participants • One subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening	1 Participants n=120 Participants • One subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening	2 Participants n=237 Participants • One subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening
LOCS III: Nuclear Color NA	0 Participants n=117 Participants • One subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening	2 Participants n=120 Participants • One subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening	2 Participants n=237 Participants • One subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening
LOCS III: Nuclear Opalescence NO1	11 Participants n=117 Participants • One subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening	7 Participants n=120 Participants • One subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening	18 Participants n=237 Participants • One subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening
LOCS III: Nuclear Opalescence NO2	31 Participants n=117 Participants • One subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening	38 Participants n=120 Participants • One subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening	69 Participants n=237 Participants • One subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening
LOCS III: Nuclear Opalescence NO3	44 Participants n=117 Participants • One subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening	43 Participants n=120 Participants • One subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening	87 Participants n=237 Participants • One subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening
LOCS III: Nuclear Opalescence NO4	6 Participants n=117 Participants • One subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening	7 Participants n=120 Participants • One subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening	13 Participants n=237 Participants • One subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening
LOCS III: Nuclear Opalescence NO5	6 Participants n=117 Participants • One subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening	4 Participants n=120 Participants • One subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening	10 Participants n=237 Participants • One subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening
LOCS III: Nuclear Opalescence NO6	1 Participants n=117 Participants • One subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening	0 Participants n=120 Participants • One subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening	1 Participants n=237 Participants • One subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening
LOCS III: Nuclear Opalescence N/A	18 Participants n=117 Participants • One subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening	21 Participants n=120 Participants • One subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening	39 Participants n=237 Participants • One subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening
LOCS III: Cortical Opacity C1	28 Participants n=116 Participants • Although subjects qualified for the study, some layers of the lens did not present with cataract according to the LOCS scoring system and were marked as NA; therefore, this data is not available, and the number analyzed in row differs from the overall. Additionally, one subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening.	29 Participants n=119 Participants • Although subjects qualified for the study, some layers of the lens did not present with cataract according to the LOCS scoring system and were marked as NA; therefore, this data is not available, and the number analyzed in row differs from the overall. Additionally, one subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening.	57 Participants n=235 Participants • Although subjects qualified for the study, some layers of the lens did not present with cataract according to the LOCS scoring system and were marked as NA; therefore, this data is not available, and the number analyzed in row differs from the overall. Additionally, one subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening.
LOCS III: Cortical Opacity C2	20 Participants n=116 Participants • Although subjects qualified for the study, some layers of the lens did not present with cataract according to the LOCS scoring system and were marked as NA; therefore, this data is not available, and the number analyzed in row differs from the overall. Additionally, one subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening.	34 Participants n=119 Participants • Although subjects qualified for the study, some layers of the lens did not present with cataract according to the LOCS scoring system and were marked as NA; therefore, this data is not available, and the number analyzed in row differs from the overall. Additionally, one subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening.	54 Participants n=235 Participants • Although subjects qualified for the study, some layers of the lens did not present with cataract according to the LOCS scoring system and were marked as NA; therefore, this data is not available, and the number analyzed in row differs from the overall. Additionally, one subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening.
LOCS III: Cortical Opacity C3	18 Participants n=116 Participants • Although subjects qualified for the study, some layers of the lens did not present with cataract according to the LOCS scoring system and were marked as NA; therefore, this data is not available, and the number analyzed in row differs from the overall. Additionally, one subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening.	18 Participants n=119 Participants • Although subjects qualified for the study, some layers of the lens did not present with cataract according to the LOCS scoring system and were marked as NA; therefore, this data is not available, and the number analyzed in row differs from the overall. Additionally, one subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening.	36 Participants n=235 Participants • Although subjects qualified for the study, some layers of the lens did not present with cataract according to the LOCS scoring system and were marked as NA; therefore, this data is not available, and the number analyzed in row differs from the overall. Additionally, one subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening.
LOCS III: Cortical Opacity C4	4 Participants n=116 Participants • Although subjects qualified for the study, some layers of the lens did not present with cataract according to the LOCS scoring system and were marked as NA; therefore, this data is not available, and the number analyzed in row differs from the overall. Additionally, one subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening.	3 Participants n=119 Participants • Although subjects qualified for the study, some layers of the lens did not present with cataract according to the LOCS scoring system and were marked as NA; therefore, this data is not available, and the number analyzed in row differs from the overall. Additionally, one subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening.	7 Participants n=235 Participants • Although subjects qualified for the study, some layers of the lens did not present with cataract according to the LOCS scoring system and were marked as NA; therefore, this data is not available, and the number analyzed in row differs from the overall. Additionally, one subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening.
LOCS III: Cortical Opacity C5	2 Participants n=116 Participants • Although subjects qualified for the study, some layers of the lens did not present with cataract according to the LOCS scoring system and were marked as NA; therefore, this data is not available, and the number analyzed in row differs from the overall. Additionally, one subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening.	1 Participants n=119 Participants • Although subjects qualified for the study, some layers of the lens did not present with cataract according to the LOCS scoring system and were marked as NA; therefore, this data is not available, and the number analyzed in row differs from the overall. Additionally, one subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening.	3 Participants n=235 Participants • Although subjects qualified for the study, some layers of the lens did not present with cataract according to the LOCS scoring system and were marked as NA; therefore, this data is not available, and the number analyzed in row differs from the overall. Additionally, one subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening.
LOCS III: Cortical Opacity NA	44 Participants n=116 Participants • Although subjects qualified for the study, some layers of the lens did not present with cataract according to the LOCS scoring system and were marked as NA; therefore, this data is not available, and the number analyzed in row differs from the overall. Additionally, one subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening.	34 Participants n=119 Participants • Although subjects qualified for the study, some layers of the lens did not present with cataract according to the LOCS scoring system and were marked as NA; therefore, this data is not available, and the number analyzed in row differs from the overall. Additionally, one subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening.	78 Participants n=235 Participants • Although subjects qualified for the study, some layers of the lens did not present with cataract according to the LOCS scoring system and were marked as NA; therefore, this data is not available, and the number analyzed in row differs from the overall. Additionally, one subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening.
LOCS III: Posterior Subcapsular P1	27 Participants n=116 Participants • Although subjects qualified for the study, some layers of the lens did not present with cataract according to the LOCS scoring system and were marked as NA; therefore, this data is not available, and the number analyzed in row differs from the overall. Additionally, one subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening.	27 Participants n=118 Participants • Although subjects qualified for the study, some layers of the lens did not present with cataract according to the LOCS scoring system and were marked as NA; therefore, this data is not available, and the number analyzed in row differs from the overall. Additionally, one subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening.	54 Participants n=234 Participants • Although subjects qualified for the study, some layers of the lens did not present with cataract according to the LOCS scoring system and were marked as NA; therefore, this data is not available, and the number analyzed in row differs from the overall. Additionally, one subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening.
LOCS III: Posterior Subcapsular P2	12 Participants n=116 Participants • Although subjects qualified for the study, some layers of the lens did not present with cataract according to the LOCS scoring system and were marked as NA; therefore, this data is not available, and the number analyzed in row differs from the overall. Additionally, one subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening.	13 Participants n=118 Participants • Although subjects qualified for the study, some layers of the lens did not present with cataract according to the LOCS scoring system and were marked as NA; therefore, this data is not available, and the number analyzed in row differs from the overall. Additionally, one subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening.	25 Participants n=234 Participants • Although subjects qualified for the study, some layers of the lens did not present with cataract according to the LOCS scoring system and were marked as NA; therefore, this data is not available, and the number analyzed in row differs from the overall. Additionally, one subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening.
LOCS III: Posterior Subcapsular P3	5 Participants n=116 Participants • Although subjects qualified for the study, some layers of the lens did not present with cataract according to the LOCS scoring system and were marked as NA; therefore, this data is not available, and the number analyzed in row differs from the overall. Additionally, one subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening.	4 Participants n=118 Participants • Although subjects qualified for the study, some layers of the lens did not present with cataract according to the LOCS scoring system and were marked as NA; therefore, this data is not available, and the number analyzed in row differs from the overall. Additionally, one subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening.	9 Participants n=234 Participants • Although subjects qualified for the study, some layers of the lens did not present with cataract according to the LOCS scoring system and were marked as NA; therefore, this data is not available, and the number analyzed in row differs from the overall. Additionally, one subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening.
LOCS III: Posterior Subcapsular P4	3 Participants n=116 Participants • Although subjects qualified for the study, some layers of the lens did not present with cataract according to the LOCS scoring system and were marked as NA; therefore, this data is not available, and the number analyzed in row differs from the overall. Additionally, one subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening.	4 Participants n=118 Participants • Although subjects qualified for the study, some layers of the lens did not present with cataract according to the LOCS scoring system and were marked as NA; therefore, this data is not available, and the number analyzed in row differs from the overall. Additionally, one subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening.	7 Participants n=234 Participants • Although subjects qualified for the study, some layers of the lens did not present with cataract according to the LOCS scoring system and were marked as NA; therefore, this data is not available, and the number analyzed in row differs from the overall. Additionally, one subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening.
LOCS III: Posterior Subcapsular P5	0 Participants n=116 Participants • Although subjects qualified for the study, some layers of the lens did not present with cataract according to the LOCS scoring system and were marked as NA; therefore, this data is not available, and the number analyzed in row differs from the overall. Additionally, one subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening.	0 Participants n=118 Participants • Although subjects qualified for the study, some layers of the lens did not present with cataract according to the LOCS scoring system and were marked as NA; therefore, this data is not available, and the number analyzed in row differs from the overall. Additionally, one subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening.	0 Participants n=234 Participants • Although subjects qualified for the study, some layers of the lens did not present with cataract according to the LOCS scoring system and were marked as NA; therefore, this data is not available, and the number analyzed in row differs from the overall. Additionally, one subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening.
LOCS III: Posterior Subcapsular NA	69 Participants n=116 Participants • Although subjects qualified for the study, some layers of the lens did not present with cataract according to the LOCS scoring system and were marked as NA; therefore, this data is not available, and the number analyzed in row differs from the overall. Additionally, one subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening.	70 Participants n=118 Participants • Although subjects qualified for the study, some layers of the lens did not present with cataract according to the LOCS scoring system and were marked as NA; therefore, this data is not available, and the number analyzed in row differs from the overall. Additionally, one subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening.	139 Participants n=234 Participants • Although subjects qualified for the study, some layers of the lens did not present with cataract according to the LOCS scoring system and were marked as NA; therefore, this data is not available, and the number analyzed in row differs from the overall. Additionally, one subject was randomized (Toric IOL) but not treated due to a Screen Failure upon re-screening.

PRIMARY outcome

Timeframe: 120 to 180 days post-operatively

Mean magnitude of residual manifest cylinder (as measured by manifest refractive cylinder).

Outcome measures

Outcome measures
Measure	Toric (Test) Group n=117 Participants All subjects randomized to be implanted with the low cylinder (1.50 D) RayOne EMV Toric IOL (Model RAO210T) RayOne EMV Toric IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts	Monofocal (Control) Group n=116 Participants All subjects randomized to be implanted with the RAO600C Monofocal IOL RayOne Monofocal IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts	Toric (Test) Group With High Preoperative Keratometric Cylinder All subjects randomized to be implanted with the low cylinder (1.50 D) RayOne EMV Toric IOL (Model RAO210T) with low preoperative keratometric cylinder (1.25 to 1.5 D) RayOne EMV Toric IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts	Monofocal (Control) Group With High Preoperative Keratometric Cylinder All subjects randomized to be implanted with the RAO600C Monofocal IOL with low preoperative keratometric cylinder (1.25 to 1.5 D) RayOne Monofocal IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts
Mean Magnitude of Residual Manifest Cylinder	-0.368 Diopters Standard Deviation 0.334	-0.780 Diopters Standard Deviation 0.532	—	—

PRIMARY outcome

Timeframe: 120 to 180 days post-operatively

The adjusted mean difference of residual manifest cylinder (as measured by manifest refractive cylinder) between Toric and Monofocal groups will be given together with a 95% confidence interval and associated one-sided p-value. This endpoint will be considered successful if the one-sided p-value ≤ 0.025.

Outcome measures

Outcome measures
Measure	Toric (Test) Group n=238 Participants All subjects randomized to be implanted with the low cylinder (1.50 D) RayOne EMV Toric IOL (Model RAO210T) RayOne EMV Toric IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts	Monofocal (Control) Group All subjects randomized to be implanted with the RAO600C Monofocal IOL RayOne Monofocal IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts	Toric (Test) Group With High Preoperative Keratometric Cylinder All subjects randomized to be implanted with the low cylinder (1.50 D) RayOne EMV Toric IOL (Model RAO210T) with low preoperative keratometric cylinder (1.25 to 1.5 D) RayOne EMV Toric IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts	Monofocal (Control) Group With High Preoperative Keratometric Cylinder All subjects randomized to be implanted with the RAO600C Monofocal IOL with low preoperative keratometric cylinder (1.25 to 1.5 D) RayOne Monofocal IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts
Adjusted Mean Difference Magnitude of Residual Manifest Cylinder	-0.430 Diopters Interval -0.5441 to -0.3159	—	—	—

PRIMARY outcome

Timeframe: 120 to 180 days post-operatively

Frequency and percentage of RayOne EMV Toric (Model RAO210T) IOLs with IOL axis misalignment at Visit 4 (as determined by photographic method) less than 10 degrees.

Outcome measures

Outcome measures
Measure	Toric (Test) Group n=98 Participants All subjects randomized to be implanted with the low cylinder (1.50 D) RayOne EMV Toric IOL (Model RAO210T) RayOne EMV Toric IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts	Monofocal (Control) Group All subjects randomized to be implanted with the RAO600C Monofocal IOL RayOne Monofocal IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts	Toric (Test) Group With High Preoperative Keratometric Cylinder All subjects randomized to be implanted with the low cylinder (1.50 D) RayOne EMV Toric IOL (Model RAO210T) with low preoperative keratometric cylinder (1.25 to 1.5 D) RayOne EMV Toric IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts	Monofocal (Control) Group With High Preoperative Keratometric Cylinder All subjects randomized to be implanted with the RAO600C Monofocal IOL with low preoperative keratometric cylinder (1.25 to 1.5 D) RayOne Monofocal IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts
Axis Misalignment (Frequency and Percentage 10 Degrees)	92 Participants	—	—	—

PRIMARY outcome

Timeframe: 120 to 180 days post-operatively

Frequency and percentage of RayOne EMV Toric (Model RAO210T) IOLs with IOL axis misalignment at Visit 4 (as determined by photographic method) less than 20 degrees.

Outcome measures

Outcome measures
Measure	Toric (Test) Group n=98 Participants All subjects randomized to be implanted with the low cylinder (1.50 D) RayOne EMV Toric IOL (Model RAO210T) RayOne EMV Toric IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts	Monofocal (Control) Group All subjects randomized to be implanted with the RAO600C Monofocal IOL RayOne Monofocal IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts	Toric (Test) Group With High Preoperative Keratometric Cylinder All subjects randomized to be implanted with the low cylinder (1.50 D) RayOne EMV Toric IOL (Model RAO210T) with low preoperative keratometric cylinder (1.25 to 1.5 D) RayOne EMV Toric IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts	Monofocal (Control) Group With High Preoperative Keratometric Cylinder All subjects randomized to be implanted with the RAO600C Monofocal IOL with low preoperative keratometric cylinder (1.25 to 1.5 D) RayOne Monofocal IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts
Axis Misalignment (Frequency and Percentage 20 Degrees)	98 Participants	—	—	—

PRIMARY outcome

Timeframe: 30 to 60 days and 120 to 180 days post-operatively

Stability of toric IOL axis orientation, expressed as frequency and percentage of RayOne EMV Toric (Model RAO210T) IOLs that rotate ≤ 5 degrees postoperatively between 30 to 60 days (Visit 3) and 120 to 180 days (Visit 4)

Outcome measures

Outcome measures
Measure	Toric (Test) Group n=101 Participants All subjects randomized to be implanted with the low cylinder (1.50 D) RayOne EMV Toric IOL (Model RAO210T) RayOne EMV Toric IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts	Monofocal (Control) Group All subjects randomized to be implanted with the RAO600C Monofocal IOL RayOne Monofocal IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts	Toric (Test) Group With High Preoperative Keratometric Cylinder All subjects randomized to be implanted with the low cylinder (1.50 D) RayOne EMV Toric IOL (Model RAO210T) with low preoperative keratometric cylinder (1.25 to 1.5 D) RayOne EMV Toric IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts	Monofocal (Control) Group With High Preoperative Keratometric Cylinder All subjects randomized to be implanted with the RAO600C Monofocal IOL with low preoperative keratometric cylinder (1.25 to 1.5 D) RayOne Monofocal IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts
Stability of Toric IOL Axis Orientation (Frequency and Percentage)	100 Participants	—	—	—

PRIMARY outcome

Timeframe: 120 to 180 days post-operatively

Rates of IOL adverse events through 120 to 180 days post-operatively (Visit 4) compared to the ISO Safety and Performance Endpoint (SPE) rates as described in ISO 11979-7. Rates of cumulative and persistent adverse events from ISO 11979-7 (2018) Table E.2 will be reported by treatment group (Toric test group, Monofocal control group) and AE type. Rates of adverse events will be compared to the SPE rate from Table E.2. The one-sided p-value from the exact binomial test of each hypothesis will also be provided for each adverse event. If none of these hypothesis test results are statistically significant, this endpoint will be considered successful for the toric IOL.

Outcome measures

Outcome measures
Measure	Toric (Test) Group n=117 Participants All subjects randomized to be implanted with the low cylinder (1.50 D) RayOne EMV Toric IOL (Model RAO210T) RayOne EMV Toric IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts	Monofocal (Control) Group n=116 Participants All subjects randomized to be implanted with the RAO600C Monofocal IOL RayOne Monofocal IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts	Toric (Test) Group With High Preoperative Keratometric Cylinder All subjects randomized to be implanted with the low cylinder (1.50 D) RayOne EMV Toric IOL (Model RAO210T) with low preoperative keratometric cylinder (1.25 to 1.5 D) RayOne EMV Toric IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts	Monofocal (Control) Group With High Preoperative Keratometric Cylinder All subjects randomized to be implanted with the RAO600C Monofocal IOL with low preoperative keratometric cylinder (1.25 to 1.5 D) RayOne Monofocal IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts
Rates of IOL Adverse Events Per ISO 11979-7 Cumulative - Cystoid macular edema	2 Participants	1 Participants	—	—
Rates of IOL Adverse Events Per ISO 11979-7 Cumulative - Hypopyon	0 Participants	0 Participants	—	—
Rates of IOL Adverse Events Per ISO 11979-7 Cumulative - Endophthalmitis	0 Participants	0 Participants	—	—
Rates of IOL Adverse Events Per ISO 11979-7 Cumulative - Lens dislocation from posterior chamber	0 Participants	0 Participants	—	—
Rates of IOL Adverse Events Per ISO 11979-7 Cumulative - Mechanical pupillary block	0 Participants	0 Participants	—	—
Rates of IOL Adverse Events Per ISO 11979-7 Cumulative - Retinal detachment	0 Participants	0 Participants	—	—
Rates of IOL Adverse Events Per ISO 11979-7 Cumulative - Secondary Surgical Intervention	2 Participants	0 Participants	—	—
Rates of IOL Adverse Events Per ISO 11979-7 Persistent - Cornea Stroma Edema	0 Participants	0 Participants	—	—
Rates of IOL Adverse Events Per ISO 11979-7 Persistent - Cystoid macular edema	0 Participants	0 Participants	—	—
Rates of IOL Adverse Events Per ISO 11979-7 Persistent - Iritis	0 Participants	0 Participants	—	—
Rates of IOL Adverse Events Per ISO 11979-7 Persistent - Increased IOP	0 Participants	0 Participants	—	—

PRIMARY outcome

Timeframe: 120 to 180 days post-operatively

The eyes with at least one adverse event not included in the cumulative and persistent adverse events from ISO 11979-7 (2018) Table E.2 through 120 to 180 days post-operatively (Visit 4) will be presented by treatment group (Toric test group, Monofocal control group).

Outcome measures

Outcome measures
Measure	Toric (Test) Group n=117 Participants All subjects randomized to be implanted with the low cylinder (1.50 D) RayOne EMV Toric IOL (Model RAO210T) RayOne EMV Toric IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts	Monofocal (Control) Group n=116 Participants All subjects randomized to be implanted with the RAO600C Monofocal IOL RayOne Monofocal IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts	Toric (Test) Group With High Preoperative Keratometric Cylinder All subjects randomized to be implanted with the low cylinder (1.50 D) RayOne EMV Toric IOL (Model RAO210T) with low preoperative keratometric cylinder (1.25 to 1.5 D) RayOne EMV Toric IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts	Monofocal (Control) Group With High Preoperative Keratometric Cylinder All subjects randomized to be implanted with the RAO600C Monofocal IOL with low preoperative keratometric cylinder (1.25 to 1.5 D) RayOne Monofocal IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts
Rates of All Other Adverse Events Not Included in ISO 11979-7 Cornea Stroma Edema	6 Participants	5 Participants	—	—
Rates of All Other Adverse Events Not Included in ISO 11979-7 Increased IOP	4 Participants	7 Participants	—	—
Rates of All Other Adverse Events Not Included in ISO 11979-7 IOL decentration/malposition resulting in secondary surgical intervention	1 Participants	0 Participants	—	—
Rates of All Other Adverse Events Not Included in ISO 11979-7 Iris pigment epithelium loss	1 Participants	0 Participants	—	—
Rates of All Other Adverse Events Not Included in ISO 11979-7 Progression or onset diabetic retinopathy	1 Participants	0 Participants	—	—
Rates of All Other Adverse Events Not Included in ISO 11979-7 Retained lens material	1 Participants	0 Participants	—	—
Rates of All Other Adverse Events Not Included in ISO 11979-7 Secondary Surgical Intervention - Wound burp (aqueous tap, or paracentesis)	1 Participants	0 Participants	—	—
Rates of All Other Adverse Events Not Included in ISO 11979-7 Other - Posterior capsular opacification requiring YAG capsulotomy	14 Participants	4 Participants	—	—
Rates of All Other Adverse Events Not Included in ISO 11979-7 Other - Posterior vitreous detachment	7 Participants	11 Participants	—	—
Rates of All Other Adverse Events Not Included in ISO 11979-7 Other - Corneal edema	7 Participants	7 Participants	—	—
Rates of All Other Adverse Events Not Included in ISO 11979-7 Other - Anterior chamber cells greater than Grade 2 at Visit 1	5 Participants	1 Participants	—	—
Rates of All Other Adverse Events Not Included in ISO 11979-7 Other - Corneal abrasion	3 Participants	0 Participants	—	—
Rates of All Other Adverse Events Not Included in ISO 11979-7 Other - Epithelial defect	2 Participants	1 Participants	—	—
Rates of All Other Adverse Events Not Included in ISO 11979-7 Other - Choroidal nevus	1 Participants	1 Participants	—	—
Rates of All Other Adverse Events Not Included in ISO 11979-7 Other - Corneal dellen	1 Participants	1 Participants	—	—
Rates of All Other Adverse Events Not Included in ISO 11979-7 Other - Dermatochalasis	1 Participants	1 Participants	—	—
Rates of All Other Adverse Events Not Included in ISO 11979-7 Other - Epiretinal membrane	2 Participants	0 Participants	—	—
Rates of All Other Adverse Events Not Included in ISO 11979-7 Other - Subconjunctival hemorrhage	1 Participants	1 Participants	—	—
Rates of All Other Adverse Events Not Included in ISO 11979-7 Other - Worsening dry eye disease	1 Participants	1 Participants	—	—
Rates of All Other Adverse Events Not Included in ISO 11979-7 Other - Central capsular wrinkle	1 Participants	0 Participants	—	—
Rates of All Other Adverse Events Not Included in ISO 11979-7 Other - Chemosis	1 Participants	0 Participants	—	—
Rates of All Other Adverse Events Not Included in ISO 11979-7 Other - Double vision secondary to neurological adjustment following cataract surgery	1 Participants	0 Participants	—	—
Rates of All Other Adverse Events Not Included in ISO 11979-7 Other - Worsening punctate epithelial erosion	1 Participants	0 Participants	—	—
Rates of All Other Adverse Events Not Included in ISO 11979-7 Other - Epithelial basement membrane dystrophy	1 Participants	0 Participants	—	—
Rates of All Other Adverse Events Not Included in ISO 11979-7 Other - Intraretinal hemorrhage	1 Participants	0 Participants	—	—
Rates of All Other Adverse Events Not Included in ISO 11979-7 Other - Photophobia	1 Participants	0 Participants	—	—
Rates of All Other Adverse Events Not Included in ISO 11979-7 Other - Retinal pigment epithelial mottling	1 Participants	0 Participants	—	—
Rates of All Other Adverse Events Not Included in ISO 11979-7 Other - Superficial punctate keratitis	1 Participants	0 Participants	—	—
Rates of All Other Adverse Events Not Included in ISO 11979-7 Other - Trace punctate epithelial erosions	1 Participants	0 Participants	—	—
Rates of All Other Adverse Events Not Included in ISO 11979-7 Other - Visually significant corneal edema resulting in BCDVA of 0.3 or worse	1 Participants	0 Participants	—	—
Rates of All Other Adverse Events Not Included in ISO 11979-7 Other - Conjunctival injection	0 Participants	2 Participants	—	—
Rates of All Other Adverse Events Not Included in ISO 11979-7 Other - Dry eye disease	0 Participants	1 Participants	—	—
Rates of All Other Adverse Events Not Included in ISO 11979-7 Other - Iritis	0 Participants	1 Participants	—	—
Rates of All Other Adverse Events Not Included in ISO 11979-7 Other - Keratoconjunctivitis Sicca, not specified as Sjogrens	0 Participants	1 Participants	—	—
Rates of All Other Adverse Events Not Included in ISO 11979-7 Other - Retinal pigment epithelial changes	0 Participants	1 Participants	—	—

PRIMARY outcome

Timeframe: 120 to 180 days post-operatively

The percentage of eyes implanted with the Toric test group IOL requiring a secondary surgical intervention for IOL repositioning due to IOL misalignment through 120 to 180 days post-operatively (Visit 4), as well as a two-sided 95% exact binomial confidence interval for the percentage, will be presented.

Outcome measures

Outcome measures
Measure	Toric (Test) Group n=117 Participants All subjects randomized to be implanted with the low cylinder (1.50 D) RayOne EMV Toric IOL (Model RAO210T) RayOne EMV Toric IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts	Monofocal (Control) Group All subjects randomized to be implanted with the RAO600C Monofocal IOL RayOne Monofocal IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts	Toric (Test) Group With High Preoperative Keratometric Cylinder All subjects randomized to be implanted with the low cylinder (1.50 D) RayOne EMV Toric IOL (Model RAO210T) with low preoperative keratometric cylinder (1.25 to 1.5 D) RayOne EMV Toric IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts	Monofocal (Control) Group With High Preoperative Keratometric Cylinder All subjects randomized to be implanted with the RAO600C Monofocal IOL with low preoperative keratometric cylinder (1.25 to 1.5 D) RayOne Monofocal IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts
Rates of Secondary Surgical Interventions for IOL Repositioning Due to IOL Misalignment	1 Participants	—	—	—

PRIMARY outcome

Timeframe: 120 to 180 days post-operatively

Population: Toric subjects 01-003, 01-009, 01-026, 01-027, 01-030 and 05-009; and Monofocal subjects 07-031 and 08-036; are excluded from the PP Set due to Major Protocol Deviations. Per Protocol Monofocal subjects 02-006, 03-064, 05-012, 05-014 were excluded from the BCS due to significant pre-operative ocular pathology in the study eye. No Per Protocol Toric subjects were excluded from the BCS.

The percentage of eyes that achieve a BCDVA at 4 meters of 0.30 logMAR or better at 120 to 180 days post-operatively (Visit 4) will be presented by treatment group (Toric test group, Monofocal control group) for the Safety Set and Best Case Set. If neither of these hypothesis test results are statistically significant, this endpoint will be considered successful for the toric IOL.

Outcome measures

Outcome measures
Measure	Toric (Test) Group n=117 Participants All subjects randomized to be implanted with the low cylinder (1.50 D) RayOne EMV Toric IOL (Model RAO210T) RayOne EMV Toric IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts	Monofocal (Control) Group n=116 Participants All subjects randomized to be implanted with the RAO600C Monofocal IOL RayOne Monofocal IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts	Toric (Test) Group With High Preoperative Keratometric Cylinder All subjects randomized to be implanted with the low cylinder (1.50 D) RayOne EMV Toric IOL (Model RAO210T) with low preoperative keratometric cylinder (1.25 to 1.5 D) RayOne EMV Toric IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts	Monofocal (Control) Group With High Preoperative Keratometric Cylinder All subjects randomized to be implanted with the RAO600C Monofocal IOL with low preoperative keratometric cylinder (1.25 to 1.5 D) RayOne Monofocal IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts
Rate of BCDVA of 0.30 logMAR or Better Compared to the ISO SPE Rates Safety Set	117 Participants	116 Participants	—	—
Rate of BCDVA of 0.30 logMAR or Better Compared to the ISO SPE Rates Best Case Set	112 Participants	111 Participants	—	—

SECONDARY outcome

Timeframe: 120 to 180 days post-operatively

Residual manifest refractive cylinder by subgroups of 0.25 D preoperative keratometric cylinder at 120 to 180 days post-operatively

Outcome measures

Outcome measures
Measure	Toric (Test) Group n=75 Participants All subjects randomized to be implanted with the low cylinder (1.50 D) RayOne EMV Toric IOL (Model RAO210T) RayOne EMV Toric IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts	Monofocal (Control) Group n=62 Participants All subjects randomized to be implanted with the RAO600C Monofocal IOL RayOne Monofocal IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts	Toric (Test) Group With High Preoperative Keratometric Cylinder n=42 Participants All subjects randomized to be implanted with the low cylinder (1.50 D) RayOne EMV Toric IOL (Model RAO210T) with low preoperative keratometric cylinder (1.25 to 1.5 D) RayOne EMV Toric IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts	Monofocal (Control) Group With High Preoperative Keratometric Cylinder n=54 Participants All subjects randomized to be implanted with the RAO600C Monofocal IOL with low preoperative keratometric cylinder (1.25 to 1.5 D) RayOne Monofocal IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts
Residual Manifest Cylinder Stratified by Preoperative Keratometric Cylinder	-0.413 Diopters Standard Deviation 0.333	-0.794 Diopters Standard Deviation 0.535	-0.286 Diopters Standard Deviation 0.325	-0.764 Diopters Standard Deviation 0.533

SECONDARY outcome

Timeframe: 120 to 180 days post-operatively

Percent reduction in absolute cylinder (as measured by residual manifest cylinder / preoperative keratometric cylinder), at 120 to 180 days post-operatively. Positive numbers represent an decrease in cylinder and negative numbers represent an increase in cylinder.

Outcome measures

Outcome measures
Measure	Toric (Test) Group n=117 Participants All subjects randomized to be implanted with the low cylinder (1.50 D) RayOne EMV Toric IOL (Model RAO210T) RayOne EMV Toric IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts	Monofocal (Control) Group n=116 Participants All subjects randomized to be implanted with the RAO600C Monofocal IOL RayOne Monofocal IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts	Toric (Test) Group With High Preoperative Keratometric Cylinder All subjects randomized to be implanted with the low cylinder (1.50 D) RayOne EMV Toric IOL (Model RAO210T) with low preoperative keratometric cylinder (1.25 to 1.5 D) RayOne EMV Toric IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts	Monofocal (Control) Group With High Preoperative Keratometric Cylinder All subjects randomized to be implanted with the RAO600C Monofocal IOL with low preoperative keratometric cylinder (1.25 to 1.5 D) RayOne Monofocal IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts
Percent Change in Absolute Cylinder Stratified by Preoperative Keratometric Cylinder	68.59 percent change Standard Deviation 29.17	36.11 percent change Standard Deviation 45.69	—	—

Adverse Events

Toric (Test) Group

Serious events: 1 serious events

Other events: 49 other events

Deaths: 0 deaths

Monofocal (Control) Group

Serious events: 0 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Toric (Test) Group n=117 participants at risk All subjects randomized to be implanted with the low cylinder (1.50 D) RayOne EMV Toric IOL (Model RAO210T) RayOne EMV Toric IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts	Monofocal (Control) Group n=116 participants at risk All subjects randomized to be implanted with the RAO600C Monofocal IOL RayOne Monofocal IOL: Implantation of intraocular lens. Cataract Surgery: Removal of natural crystalline lens due to cataracts
Eye disorders Secondary Surgical Intervention - Surgical removal of retained lens fragment	0.85% 1/117 • 6 months All AEs that occurred during or after the Pre-operative Visit through completion of study participation were recorded on the subject's case report form. The case report form included a list of anticipated AEs.	0.00% 0/116 • 6 months All AEs that occurred during or after the Pre-operative Visit through completion of study participation were recorded on the subject's case report form. The case report form included a list of anticipated AEs.

Other adverse events

Additional Information

Senior Clinical Trial Manager

Rayner Intraocular Lenses Limited

Phone: 714-398-9988

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place