Trial Outcomes & Findings for Visual and Refractive Outcomes of The ClarVista HARMONI™ Modular Intraocular Lens System (HMIOL) (NCT NCT03681886)

NCT ID: NCT03681886

Last Updated: 2021-01-05

Results Overview

Visual acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 150 participants
• Primary outcome timeframe: Day 1 post primary implantation, Week 1 post primary implantation, Month 1 post primary implantation, Month 3 post primary implantation, Month 6 post primary implantation, Month 12 post primary implantation
• Results posted on: 2021-01-05

Participant Flow

A total of 5 Investigators participated in the study; 3 in the Philippines, 1 in Mexico, and 1 in Panama.

Of the 150 subjects enrolled, 72 were exited from the study prior to attempted implantation with the HARMONI™ Modular Intraocular Lens (HMIOL) System. This reporting group includes all subjects / eyes with attempted implantation.

Unit of analysis: eyes

Participant milestones

Measure	All HMIOL Cohort Implantation of the HARMONI™ Modular Intraocular Lens (HMIOL) System in the right eye, left eye, or both eyes
Overall Study STARTED	78 100
Overall Study Successful Implantation	76 98
Overall Study Failed Implantation	2 2
Overall Study Underwent Optic Exchange	4 4
Overall Study COMPLETED	76 98
Overall Study NOT COMPLETED	2 2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Visual and Refractive Outcomes of The ClarVista HARMONI™ Modular Intraocular Lens System (HMIOL)

Baseline characteristics by cohort

Measure	All HMIOL Cohort n=78 Participants All subjects with attempted implantation of the HARMONI™ Modular Intraocular Lens (HMIOL) System in the right eye, left eye, or both eyes
Age, Continuous	68.4 years STANDARD_DEVIATION 8.98 • n=93 Participants
Sex: Female, Male Female	47 Participants n=93 Participants
Sex: Female, Male Male	31 Participants n=93 Participants
Race/Ethnicity, Customized Asian	50 Participants n=93 Participants
Race/Ethnicity, Customized Black	0 Participants n=93 Participants
Race/Ethnicity, Customized Caucasian	0 Participants n=93 Participants
Race/Ethnicity, Customized Other	28 Participants n=93 Participants

PRIMARY outcome

Timeframe: Day 1 post primary implantation, Week 1 post primary implantation, Month 1 post primary implantation, Month 3 post primary implantation, Month 6 post primary implantation, Month 12 post primary implantation

Population: Per Protocol: All subjects/eyes with successful implantation of HMIOL with no major protocol deviations and available data.

Visual acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned.

Outcome measures

Measure	Cohort 1 - Day 1 Post Primary Implantation n=96 eyes Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Week 1 Post Primary Implantation n=97 eyes Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 1 Post Primary Implantation n=97 eyes Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 3 Post Primary Implantation n=12 eyes Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 6 Post Primary Implantation n=12 eyes Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 12 Post Primary Implantation n=12 eyes Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.
Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 20/20 Snellen or Better	30.2 percentage of eyes	32.0 percentage of eyes	32.0 percentage of eyes	16.7 percentage of eyes	58.3 percentage of eyes	25.0 percentage of eyes
Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 20/25 Snellen or Better	53.1 percentage of eyes	61.9 percentage of eyes	60.8 percentage of eyes	58.3 percentage of eyes	83.3 percentage of eyes	50.0 percentage of eyes
Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 20/32 Snellen or Better	74.0 percentage of eyes	84.5 percentage of eyes	78.4 percentage of eyes	91.7 percentage of eyes	91.7 percentage of eyes	66.7 percentage of eyes
Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 20/40 Snellen or Better	85.4 percentage of eyes	89.7 percentage of eyes	93.8 percentage of eyes	91.7 percentage of eyes	100.0 percentage of eyes	100.0 percentage of eyes
Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 Worse than 20/40 Snellen	14.6 percentage of eyes	10.3 percentage of eyes	6.2 percentage of eyes	3.3 percentage of eyes	0.0 percentage of eyes	0.0 percentage of eyes

PRIMARY outcome

Timeframe: Day 0 pre optic exchange, Day 1 post optic exchange, Week 1 post optic exchange, Month 1 post optic exchange

Population: Per Protocol: All subjects/eyes with successful implantation of HMIOL with no major protocol deviations and available data.

Visual acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned. The optic exchange occurred 1 month following primary implantation with HMIOL.

Outcome measures

Measure	Cohort 1 - Day 1 Post Primary Implantation n=3 eyes Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Week 1 Post Primary Implantation n=3 eyes Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 1 Post Primary Implantation n=3 eyes Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 3 Post Primary Implantation n=3 eyes Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 6 Post Primary Implantation Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 12 Post Primary Implantation Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.
Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 20/20 Snellen or Better	0.0 percentage of eyes	66.7 percentage of eyes	66.7 percentage of eyes	66.7 percentage of eyes	—	—
Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 20/25 Snellen or Better	0.0 percentage of eyes	66.7 percentage of eyes	66.7 percentage of eyes	66.7 percentage of eyes	—	—
Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 20/32 Snellen or Better	0.0 percentage of eyes	66.7 percentage of eyes	100.0 percentage of eyes	100.0 percentage of eyes	—	—
Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 20/40 Snellen or Better	66.7 percentage of eyes	100.0 percentage of eyes	100.0 percentage of eyes	100.0 percentage of eyes	—	—
Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 Worse than 20/40 Snellen	33.3 percentage of eyes	0.0 percentage of eyes	0.0 percentage of eyes	0.0 percentage of eyes	—	—

PRIMARY outcome

Timeframe: Baseline (Day -90 to Day 0 preoperative), Week 1 post primary implantation, Month 1 post primary implantation, Month 3 post primary implantation, Month 6 post primary implantation, Month 12 post primary implantation

Population: Per Protocol: All subjects/eyes with successful implantation of HMIOL with no major protocol deviations and available data.

Visual acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant with subject manifest refraction in place. BCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned.

Outcome measures

Measure	Cohort 1 - Day 1 Post Primary Implantation n=92 eyes Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Week 1 Post Primary Implantation n=97 eyes Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 1 Post Primary Implantation n=97 eyes Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 3 Post Primary Implantation n=12 eyes Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 6 Post Primary Implantation n=12 eyes Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 12 Post Primary Implantation n=12 eyes Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 20/20 Snellen or Better	13.0 percentage of eyes	76.3 percentage of eyes	72.2 percentage of eyes	83.3 percentage of eyes	91.7 percentage of eyes	58.3 percentage of eyes
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 20/25 Snellen or Better	23.9 percentage of eyes	83.5 percentage of eyes	92.8 percentage of eyes	100.0 percentage of eyes	100.0 percentage of eyes	91.7 percentage of eyes
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 20/32 Snellen or Better	44.6 percentage of eyes	94.8 percentage of eyes	96.9 percentage of eyes	100.0 percentage of eyes	100.0 percentage of eyes	100.0 percentage of eyes
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 20/40 Snellen or Better	58.7 percentage of eyes	96.9 percentage of eyes	99.0 percentage of eyes	100.0 percentage of eyes	100.0 percentage of eyes	100.0 percentage of eyes
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 Worse than 20/40 Snellen	41.3 percentage of eyes	3.1 percentage of eyes	1.0 percentage of eyes	0.0 percentage of eyes	0.0 percentage of eyes	0.0 percentage of eyes

PRIMARY outcome

Timeframe: Baseline (Day 0 pre optic exchange), Week 1 post optic exchange, Month 1 post optic exchange

Population: Per Protocol: All subjects/eyes with successful implantation of HMIOL with no major protocol deviations and available data.

Visual acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant with subject manifest refraction in place. BCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned.

Outcome measures

Measure	Cohort 1 - Day 1 Post Primary Implantation n=3 eyes Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Week 1 Post Primary Implantation n=3 eyes Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 1 Post Primary Implantation n=3 eyes Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 3 Post Primary Implantation Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 6 Post Primary Implantation Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 12 Post Primary Implantation Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 20/20 Snellen or Better	33.3 percentage of eyes	100.0 percentage of eyes	66.7 percentage of eyes	—	—	—
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 20/25 Snellen or Better	66.7 percentage of eyes	100.0 percentage of eyes	100.0 percentage of eyes	—	—	—
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 20/32 Snellen or Better	100.0 percentage of eyes	100.0 percentage of eyes	100.0 percentage of eyes	—	—	—
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 20/40 Snellen or Better	100.0 percentage of eyes	100.0 percentage of eyes	100.0 percentage of eyes	—	—	—
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 Worse than 20/40 Snellen	0.0 percentage of eyes	0.0 percentage of eyes	0.0 percentage of eyes	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day -90 to Day 0 preoperative), Week 1 post primary implantation, Month 1 post primary implantation, Month 3 post primary implantation, Month 6 post primary implantation, Month 12 post primary implantation

Population: Per Protocol: All subjects/eyes with successful implantation of HMIOL with no major protocol deviations and available data.

A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The subject was manually refracted to his/her best correction. The manifest refraction spherical equivalent (MRSE) was measured in diopters (D) and calculated as follows: sphere + 1/2 cylinder. A less negative value indicates a more accurate IOL power calculation. No formal statistical hypothesis testing was planned.

Outcome measures

Measure	Cohort 1 - Day 1 Post Primary Implantation n=97 eyes Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Week 1 Post Primary Implantation n=97 eyes Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 1 Post Primary Implantation n=97 eyes Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 3 Post Primary Implantation n=12 eyes Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 6 Post Primary Implantation n=12 eyes Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 12 Post Primary Implantation n=12 eyes Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.
Mean Manifest Refraction Spherical Equivalent (MRSE) by Visit - Cohort 1	-0.53 diopter Standard Deviation 2.70	-0.28 diopter Standard Deviation 0.62	-0.29 diopter Standard Deviation 0.63	-0.58 diopter Standard Deviation 0.57	-0.49 diopter Standard Deviation 0.61	-0.40 diopter Standard Deviation 0.69

PRIMARY outcome

Timeframe: Baseline (Day 0 pre optic exchange), Week 1 post optic exchange, Month 1 post optic exchange

Population: Per Protocol: All subjects/eyes with successful implantation of HMIOL with no major protocol deviations and available data.

A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The subject was manually refracted to his/her best correction. The manifest refraction spherical equivalent (MRSE) was measured in diopters (D) and calculated as follows: sphere + 1/2 cylinder. A less negative value indicates a more accurate IOL power calculation. No formal statistical hypothesis testing was planned.

Outcome measures

Measure	Cohort 1 - Day 1 Post Primary Implantation n=3 eyes Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Week 1 Post Primary Implantation n=3 eyes Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 1 Post Primary Implantation n=3 eyes Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 3 Post Primary Implantation Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 6 Post Primary Implantation Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 12 Post Primary Implantation Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.
Mean Manifest Refraction Spherical Equivalent (MRSE) by Visit - Cohort 2	-1.54 diopter Standard Deviation 0.56	-0.25 diopter Standard Deviation 0.25	-0.17 diopter Standard Deviation 0.29	—	—	—

PRIMARY outcome

Timeframe: Day 0 primary implantation

Population: Safety Population: All eyes with attempted HMIOL implantation (successful or aborted after contact with the eye) and available data

The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned.

Outcome measures

Measure	Cohort 1 - Day 1 Post Primary Implantation n=98 eyes Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Week 1 Post Primary Implantation Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 1 Post Primary Implantation Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 3 Post Primary Implantation Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 6 Post Primary Implantation Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 12 Post Primary Implantation Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.
Number of Surgeon Responses to Primary Surgery Question: How Would You Rate the Surgical Difficulty of the Base Implantation? - All HMIOL Cohort Easier than a traditional single piece IOL	35 surgeon response	—	—	—	—	—
Number of Surgeon Responses to Primary Surgery Question: How Would You Rate the Surgical Difficulty of the Base Implantation? - All HMIOL Cohort Slightly easier than a traditional single piece IO	16 surgeon response	—	—	—	—	—
Number of Surgeon Responses to Primary Surgery Question: How Would You Rate the Surgical Difficulty of the Base Implantation? - All HMIOL Cohort The same as a traditional single piece IOL	11 surgeon response	—	—	—	—	—
Number of Surgeon Responses to Primary Surgery Question: How Would You Rate the Surgical Difficulty of the Base Implantation? - All HMIOL Cohort Slightly more difficult than a trd'l single pc IOL	34 surgeon response	—	—	—	—	—
Number of Surgeon Responses to Primary Surgery Question: How Would You Rate the Surgical Difficulty of the Base Implantation? - All HMIOL Cohort More difficult than a traditional single piece IOL	2 surgeon response	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 0 primary implantation

Population: Safety Population: All eyes with attempted HMIOL implantation (successful or aborted after contact with the eye) and available data

The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned.

Outcome measures

Measure	Cohort 1 - Day 1 Post Primary Implantation n=98 eyes Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Week 1 Post Primary Implantation Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 1 Post Primary Implantation Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 3 Post Primary Implantation Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 6 Post Primary Implantation Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 12 Post Primary Implantation Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.
Number of Surgeon Responses to Primary Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Implantation and Assembly? - All HMIOL Cohort Very easy	31 surgeon response	—	—	—	—	—
Number of Surgeon Responses to Primary Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Implantation and Assembly? - All HMIOL Cohort Easy	23 surgeon response	—	—	—	—	—
Number of Surgeon Responses to Primary Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Implantation and Assembly? - All HMIOL Cohort Neutral	35 surgeon response	—	—	—	—	—
Number of Surgeon Responses to Primary Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Implantation and Assembly? - All HMIOL Cohort Difficult	8 surgeon response	—	—	—	—	—
Number of Surgeon Responses to Primary Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Implantation and Assembly? - All HMIOL Cohort Very difficult	1 surgeon response	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 0 post-exchange

Population: Safety Population: All eyes with attempted HMIOL implantation (successful or aborted after contact with the eye) and available data

The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned.

Outcome measures

Measure	Cohort 1 - Day 1 Post Primary Implantation n=4 eyes Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Week 1 Post Primary Implantation Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 1 Post Primary Implantation Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 3 Post Primary Implantation Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 6 Post Primary Implantation Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 12 Post Primary Implantation Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.
Number of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Implantation and Assembly (Exchange)? - Cohort 2 Very easy	1 surgeon response	—	—	—	—	—
Number of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Implantation and Assembly (Exchange)? - Cohort 2 Easy	1 surgeon response	—	—	—	—	—
Number of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Implantation and Assembly (Exchange)? - Cohort 2 Neutral	2 surgeon response	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 0 post-exchange

Population: Safety Population: All eyes with attempted HMIOL implantation (successful or aborted after contact with the eye) and available data

The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned.

Outcome measures

Measure	Cohort 1 - Day 1 Post Primary Implantation n=4 eyes Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Week 1 Post Primary Implantation Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 1 Post Primary Implantation Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 3 Post Primary Implantation Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 6 Post Primary Implantation Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 12 Post Primary Implantation Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.
Number of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Disassembly? - Cohort 2 Very easy	1 surgeon response	—	—	—	—	—
Number of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Disassembly? - Cohort 2 Easy	3 surgeon response	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 0 post-exchange

Population: Safety Population: All eyes with attempted HMIOL implantation (successful or aborted after contact with the eye) and available data

The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned.

Outcome measures

Measure	Cohort 1 - Day 1 Post Primary Implantation n=4 eyes Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Week 1 Post Primary Implantation Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 1 Post Primary Implantation Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 3 Post Primary Implantation Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 6 Post Primary Implantation Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 12 Post Primary Implantation Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.
Number of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Explantation? - Cohort 2 Neutral	2 surgeon response	—	—	—	—	—
Number of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Explantation? - Cohort 2 Very easy	1 surgeon response	—	—	—	—	—
Number of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Explantation? - Cohort 2 Easy	1 surgeon response	—	—	—	—	—

PRIMARY outcome

Timeframe: Cohort 1: Up to one month post primary implantation, with one site followed up to 12 months. Cohort 2: Up to one month post exchange, for a total of up to 2 months.

Population: Safety Population: All eyes with attempted HMIOL implantation (successful or aborted after contact with the eye) and available data

A secondary surgical intervention (SSI) was defined as a surgical procedure that occurred after primary implantation and was conducted for the purpose of resolving residual refractive error (RRE) and optimizing visual outcomes, as determined by the investigator. No formal statistical hypothesis testing was planned.

Outcome measures

Measure	Cohort 1 - Day 1 Post Primary Implantation n=100 eyes Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Week 1 Post Primary Implantation Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 1 Post Primary Implantation Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 3 Post Primary Implantation Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 6 Post Primary Implantation Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 12 Post Primary Implantation Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.
Number of Secondary Surgical Interventions (SSI) (Other Than Optic Exchange)	4 SSI	—	—	—	—	—

PRIMARY outcome

Timeframe: Cohort 1: Up to one month post primary implantation, with one site followed up to 12 months. Cohort 2: Up to one month post exchange, for a total of up to 2 months.

Population: Safety Population: All eyes with attempted HMIOL implantation (successful or aborted after contact with the eye) and available data

A device deficiency was defined as a failure of the device to meet its performance specifications or expectations, or otherwise not perform as intended. This could include either a malfunction or damage to the device or any part thereof, regardless of the source of malfunction or damage, including user error, and regardless of the presence of injury (or lack thereof) to subject, user, or bystander. No formal statistical hypothesis testing was planned.

Outcome measures

Measure	Cohort 1 - Day 1 Post Primary Implantation n=100 eyes Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Week 1 Post Primary Implantation Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 1 Post Primary Implantation Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 3 Post Primary Implantation Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 6 Post Primary Implantation Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.	Cohort 1 - Month 12 Post Primary Implantation Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.
Number of Device Deficiencies	4 device deficiencies	—	—	—	—	—

Adverse Events

Non-Ocular

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ocular

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Non-Ocular n=78 participants at risk All subjects with attempted HMIOL implantation (successful or aborted after contact with the eye)	Ocular n=100 participants at risk All eyes with attempted HMIOL implantation (successful or aborted after contact with the eye)
Eye disorders Iridocyclitis	0.00% 0/78 • Adverse events (AEs) were collected from time of consent to study exit: Cohort 1: Up to one month post primary implantation, with one site followed up to 12 months. Cohort 2: Up to one month post exchange, for a total of up to 2 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes.	6.0% 6/100 • Adverse events (AEs) were collected from time of consent to study exit: Cohort 1: Up to one month post primary implantation, with one site followed up to 12 months. Cohort 2: Up to one month post exchange, for a total of up to 2 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes.
Investigations Intraocular pressure increased	0.00% 0/78 • Adverse events (AEs) were collected from time of consent to study exit: Cohort 1: Up to one month post primary implantation, with one site followed up to 12 months. Cohort 2: Up to one month post exchange, for a total of up to 2 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes.	9.0% 9/100 • Adverse events (AEs) were collected from time of consent to study exit: Cohort 1: Up to one month post primary implantation, with one site followed up to 12 months. Cohort 2: Up to one month post exchange, for a total of up to 2 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes.

Additional Information

Sr. Clinical Trial Lead, CDMA Surgical

Alcon, LLC

Phone: 1-888-451-3937

Email: alcon.medinfo@alcon.com

Results disclosure agreements

• Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
• Publication restrictions are in place

Restriction type: OTHER