Trial Outcomes & Findings for Pilot Study of AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens (IOL) (NCT NCT01200511)

NCT ID: NCT01200511

Last Updated: 2018-07-02

Results Overview

Visual acuity (VA) was tested binocularly (both eyes together) unaided across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 49 participants
• Primary outcome timeframe: Month 6 from second eye implantation
• Results posted on: 2018-07-02

Participant Flow

Subjects were recruited from 5 investigational sites located in Germany (2), Venezuela (2), and Spain (1).

This reporting population includes all enrolled subjects.

Participant milestones

Measure	ReSTOR +3.0 Toric AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
Overall Study STARTED	49
Overall Study COMPLETED	44
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	ReSTOR +3.0 Toric AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
Overall Study Lost to Follow-up	3
Overall Study Withdrawal by Subject	1
Overall Study Adverse Event	1

Baseline Characteristics

Pilot Study of AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens (IOL)

Baseline characteristics by cohort

Measure	ReSTOR +3.0 Toric n=44 Participants AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
Age, Continuous	62.52 years STANDARD_DEVIATION 7.49 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: Month 6 from second eye implantation

Population: This analysis population includes all subjects receiving IOL implantation in both eyes with data at visit.

Visual acuity (VA) was tested binocularly (both eyes together) unaided across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.

Outcome measures

Measure	ReSTOR +3.0 Toric n=42 Participants AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation	ReSTOR +3.0 Toric/With AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation, with corrective aids if needed
Uncorrected Visual Acuity Across a Range of Distances at Month 6 Intermediate 50 cm	0.05 logMAR Standard Deviation 0.09	—
Uncorrected Visual Acuity Across a Range of Distances at Month 6 Near 40 cm	0.07 logMAR Standard Deviation 0.09	—
Uncorrected Visual Acuity Across a Range of Distances at Month 6 Near - preferred	0.04 logMAR Standard Deviation 0.08	—
Uncorrected Visual Acuity Across a Range of Distances at Month 6 Far distance 4 meters (m)	0.05 logMAR Standard Deviation 0.10	—
Uncorrected Visual Acuity Across a Range of Distances at Month 6 Intermediate 70 centimeters (cm)	0.15 logMAR Standard Deviation 0.13	—
Uncorrected Visual Acuity Across a Range of Distances at Month 6 Intermediate 60 cm	0.09 logMAR Standard Deviation 0.11	—

PRIMARY outcome

Timeframe: Month 6 from second eye implantation

Population: This analysis population includes all subjects receiving IOL implantation in both eyes with data at visit.

VA was tested binocularly with correction in place if needed across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.

Outcome measures

Measure	ReSTOR +3.0 Toric n=42 Participants AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation	ReSTOR +3.0 Toric/With AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation, with corrective aids if needed
Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 6 Far distance 4 m	0.00 logMAR Standard Deviation 0.06	—
Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 6 Intermediate 70 cm	0.19 logMAR Standard Deviation 0.14	—
Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 6 Intermediate 60 cm	0.14 logMAR Standard Deviation 0.14	—
Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 6 Intermediate 50 cm	0.06 logMAR Standard Deviation 0.10	—
Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 6 Near 40 cm	0.04 logMAR Standard Deviation 0.07	—
Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 6 Near - preferred distance	0.05 logMAR Standard Deviation 0.08	—

PRIMARY outcome

Timeframe: Month 6 from second eye implantation

Population: This analysis population includes all subjects receiving IOL implantation in both eyes with data at visit.

Manifest refraction was performed under well-lit conditions using an ETDRS chart. The subject was manually refracted to his/her best correction by an outcomes assessor using a phoropter or trial lenses. Manifest refraction was performed for each eye. Proportion of subjects that achieved spherical equivalent within ± 0.5D/ ± 0.75D/ ± 1.0D at Month 6 is reported as percentage of subjects.

Outcome measures

Measure	ReSTOR +3.0 Toric n=44 Participants AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation	ReSTOR +3.0 Toric/With AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation, with corrective aids if needed
Proportion of Subjects That Achieved Spherical Equivalent Within ± 0.5D, ± 0.75D, and ± 1.0D at Month 6 ± 0.75D	92.9 percentage of participants	—
Proportion of Subjects That Achieved Spherical Equivalent Within ± 0.5D, ± 0.75D, and ± 1.0D at Month 6 ±1.0D	95.2 percentage of participants	—
Proportion of Subjects That Achieved Spherical Equivalent Within ± 0.5D, ± 0.75D, and ± 1.0D at Month 6 ± 0.5D	84.5 percentage of participants	—

SECONDARY outcome

Timeframe: Month 6 from second eye implantation

Population: This analysis population includes all subjects receiving IOL implantation in both eyes with data at visit. A subject may have responded with and without.

The Visual Task Difficulty Assessment (VISTAS) questionnaire was completed by the subject to assess difficulty in completing everyday tasks that depend on good vision. Distance specific tasks were rated (without / with corrective aids) using a 1 to 5 point scale, where 1 = no difficulty; 2 = minor difficulty; 3 = moderate difficulty; 4 = major difficulty; 5 = cannot accomplish. Individual scores for each task were averaged to obtain the overall score for each vision type/function. Near vision was defined as less than 50 cm; intermediate vision as 50 cm to 1 m; extended intermediate vision as 90 cm to 4 m; and distant vision as more than 4 m.

Outcome measures

Measure	ReSTOR +3.0 Toric n=44 Participants AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation	ReSTOR +3.0 Toric/With n=44 Participants AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation, with corrective aids if needed
Patient Reported Outcomes at Month 6 Near function scale score	1.72 units on a scale Standard Deviation 0.65	1.65 units on a scale Standard Deviation 0.60
Patient Reported Outcomes at Month 6 Intermediate function scale score	1.49 units on a scale Standard Deviation 0.59	1.21 units on a scale Standard Deviation 0.51
Patient Reported Outcomes at Month 6 Extended intermediate function scale score	1.24 units on a scale Standard Deviation 0.38	1.20 units on a scale Standard Deviation 0.37

Adverse Events

ReSTOR +3.0 Toric

Serious events: 7 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	ReSTOR +3.0 Toric n=49 participants at risk AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
Eye disorders Macular oedema	2.0% 1/49 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship. This analysis population includes all enrolled subjects that underwent surgery independent of IOL implantation.
Gastrointestinal disorders Gastrointestinal bleeding	2.0% 1/49 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship. This analysis population includes all enrolled subjects that underwent surgery independent of IOL implantation.
General disorders Device dislocation	6.1% 3/49 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship. This analysis population includes all enrolled subjects that underwent surgery independent of IOL implantation.
Investigations Intraocular pressure test abnormal	2.0% 1/49 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship. This analysis population includes all enrolled subjects that underwent surgery independent of IOL implantation.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.0% 1/49 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship. This analysis population includes all enrolled subjects that underwent surgery independent of IOL implantation.
Surgical and medical procedures Intraocular Lens Repositioning	6.1% 3/49 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship. This analysis population includes all enrolled subjects that underwent surgery independent of IOL implantation.

Other adverse events

Measure	ReSTOR +3.0 Toric n=49 participants at risk AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
Eye disorders Posterior capsule opacification	6.1% 3/49 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship. This analysis population includes all enrolled subjects that underwent surgery independent of IOL implantation.

Additional Information

Brand Lead, Surgical, Global Medical Affairs

Alcon Research, Ltd.

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