Trial Outcomes & Findings for Visual Outcomes After Cataract Surgery: Multifocal AcrySof® IQ ReSTOR® Intraocular Lenses Versus Monofocal Intraocular Lenses (NCT NCT01290068)

Last Updated: 2018-07-02

Results Overview

Distance VA and near VA were measured binocularly (both eyes together) without visual correction using ETDRS (Early Treatment of Diabetic Retinopathy Study) charts positioned at a consistent, manufactured distance. VA was measured in logMAR (logarithm of the minimum angle of resolution), with a lower logMAR value indicating better visual acuity. A responder was defined as a participant who achieved bilateral uncorrected distance visual acuity and bilateral uncorrected near visual acuity of ≤0.1 LogMAR at the Month 6 visit.

Recruitment status

COMPLETED

Study phase

Target enrollment

208 participants

Primary outcome timeframe

Month 6 after second eye implantation

Results posted on

2018-07-02

Participant Flow

Participants were recruited from 20 investigative sites located in France (3), Germany (4), Great Britain (1), Italy (3), Netherlands (4), and Spain (5).

This reporting group includes all randomized participants, as randomized.

Participant milestones

Participant milestones
Measure	Multifocal IOL AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation	Monofocal IOL Monofocal IOL, bilateral implantation
Overall Study STARTED	108	100
Overall Study Implanted	108	98
Overall Study COMPLETED	101	94
Overall Study NOT COMPLETED	7	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Multifocal IOL AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation	Monofocal IOL Monofocal IOL, bilateral implantation
Overall Study Adverse Event	1	3
Overall Study Lost to Follow-up	3	0
Overall Study Withdrawal by subject prior to implant	0	2
Overall Study Other	3	1

Baseline Characteristics

Visual Outcomes After Cataract Surgery: Multifocal AcrySof® IQ ReSTOR® Intraocular Lenses Versus Monofocal Intraocular Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Multifocal IOL n=108 Participants AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation	Monofocal IOL n=98 Participants Monofocal IOL, bilateral implantation	Total n=206 Participants Total of all reporting groups
Age, Customized 21 to 59 years	13 participants n=5 Participants	7 participants n=7 Participants	20 participants n=5 Participants
Age, Customized 60 to 69 years	40 participants n=5 Participants	36 participants n=7 Participants	76 participants n=5 Participants
Age, Customized 70 to 79 years	40 participants n=5 Participants	45 participants n=7 Participants	85 participants n=5 Participants
Age, Customized ≥80 years	15 participants n=5 Participants	10 participants n=7 Participants	25 participants n=5 Participants
Sex: Female, Male Female	63 Participants n=5 Participants	58 Participants n=7 Participants	121 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants	40 Participants n=7 Participants	85 Participants n=5 Participants

PRIMARY outcome

Timeframe: Month 6 after second eye implantation

Population: This analysis population includes all randomized participants to whom the randomized IOL was presented and/or implanted during the first eye surgery (from a try to a full success), as randomized. Last observation carried forward (LOCF) was used for missing data.

Outcome measures

Outcome measures
Measure	Multifocal IOL n=105 Participants AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation	Monofocal IOL n=97 Participants Monofocal IOL, bilateral implantation
Percentage of Participants Classified as Responders	45.7 percentage of participants	2.1 percentage of participants

PRIMARY outcome

Timeframe: Month 6 after second eye implantation

Spectacle independence at all distances; ie, where type of spectacles used/prescribed equaled 'No spectacles', was evaluated. If for the 6-month visit, spectacle type information was missing for the spectacle independence endpoint, but the subject attended this 6-month visit, subject was assumed to be spectacle independent.

Outcome measures

Outcome measures
Measure	Multifocal IOL n=101 Participants AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation	Monofocal IOL n=95 Participants Monofocal IOL, bilateral implantation
Proportion of Participants Reporting Spectacle Independence at All Distances	73.3 percentage of participants	25.3 percentage of participants

PRIMARY outcome

Timeframe: Month 6 after second eye implantation

Vision-related quality of life dimensions were evaluated using the National Eye Institute Refractive Error Quality of Life instrument (NEI-RQL 42), a self-administered questionnaire. Each dimension was scored between 0 to 100, with a higher score indicating a better vision-related Quality of Life. 5 of the dimensions were prespecified as primary.

Outcome measures

Outcome measures
Measure	Multifocal IOL n=108 Participants AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation	Monofocal IOL n=98 Participants Monofocal IOL, bilateral implantation
Mean Vision-Related Quality of Life as Reported on the NEI-RQL 42 (5 Dimensions) Near vision	87.63 units on a scale Standard Error 1.868	83.57 units on a scale Standard Error 1.951
Mean Vision-Related Quality of Life as Reported on the NEI-RQL 42 (5 Dimensions) Activity limitations	95.19 units on a scale Standard Error 1.431	94.85 units on a scale Standard Error 1.511
Mean Vision-Related Quality of Life as Reported on the NEI-RQL 42 (5 Dimensions) Dependence on correction	83.67 units on a scale Standard Error 3.512	46.34 units on a scale Standard Error 3.686
Mean Vision-Related Quality of Life as Reported on the NEI-RQL 42 (5 Dimensions) Appearance	84.48 units on a scale Standard Error 2.723	76.79 units on a scale Standard Error 2.875
Mean Vision-Related Quality of Life as Reported on the NEI-RQL 42 (5 Dimensions) Satisfaction with correction	84.81 units on a scale Standard Error 2.071	82.40 units on a scale Standard Error 2.179

SECONDARY outcome

Timeframe: Month 6 after second eye implantation

Population: This analysis population includes all randomized and implanted participants. If total cost was missing for a spectacle independent subject, €0 was imputed. If total cost was missing for a spectacle-dependent subject, mean cost for all spectacle dependent-subjects in that group with a known total cost for the same type of spectacles was imputed.

Total spectacle cost includes the frame, lens, and any reimbursement from national health systems or private insurance. Costs collected in pounds sterling were converted to euros.

Outcome measures

Outcome measures
Measure	Multifocal IOL n=101 Participants AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation	Monofocal IOL n=95 Participants Monofocal IOL, bilateral implantation
Median Total Spectacle Cost Prior to Any Reimbursement	0.00 euros Interval 0.0 to 8.5	85.729 euros Interval 0.0 to 147.42

Adverse Events

Multifocal IOL

Serious events: 13 serious events

Other events: 0 other events

Deaths: 0 deaths

Monofocal IOL

Serious events: 9 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Brand Lead, Surgical, Global Medical Affairs

Alcon Research, Ltd.

Phone: 1-888-451-3937

Email: [email protected]

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

Measure	Multifocal IOL n=106 participants at risk AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation	Monofocal IOL n=100 participants at risk Monofocal IOL, bilateral implantation
Cardiac disorders Cardiac disorder	0.94% 1/106 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship to the device. This reporting group includes all randomized subjects with at least 1 implanted IOL, as implanted. Note: 3 subjects randomized to Multifocal received Monofocal instead, and 1 subject randomized to Monofocal received Multifocal.	0.00% 0/100 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship to the device. This reporting group includes all randomized subjects with at least 1 implanted IOL, as implanted. Note: 3 subjects randomized to Multifocal received Monofocal instead, and 1 subject randomized to Monofocal received Multifocal.
Eye disorders Astigmatism	0.94% 1/106 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship to the device. This reporting group includes all randomized subjects with at least 1 implanted IOL, as implanted. Note: 3 subjects randomized to Multifocal received Monofocal instead, and 1 subject randomized to Monofocal received Multifocal.	0.00% 0/100 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship to the device. This reporting group includes all randomized subjects with at least 1 implanted IOL, as implanted. Note: 3 subjects randomized to Multifocal received Monofocal instead, and 1 subject randomized to Monofocal received Multifocal.
Eye disorders Corneal oedema	0.94% 1/106 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship to the device. This reporting group includes all randomized subjects with at least 1 implanted IOL, as implanted. Note: 3 subjects randomized to Multifocal received Monofocal instead, and 1 subject randomized to Monofocal received Multifocal.	0.00% 0/100 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship to the device. This reporting group includes all randomized subjects with at least 1 implanted IOL, as implanted. Note: 3 subjects randomized to Multifocal received Monofocal instead, and 1 subject randomized to Monofocal received Multifocal.
Eye disorders Cystoid macular oedema	0.94% 1/106 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship to the device. This reporting group includes all randomized subjects with at least 1 implanted IOL, as implanted. Note: 3 subjects randomized to Multifocal received Monofocal instead, and 1 subject randomized to Monofocal received Multifocal.	0.00% 0/100 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship to the device. This reporting group includes all randomized subjects with at least 1 implanted IOL, as implanted. Note: 3 subjects randomized to Multifocal received Monofocal instead, and 1 subject randomized to Monofocal received Multifocal.
Eye disorders Iridocele	0.00% 0/106 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship to the device. This reporting group includes all randomized subjects with at least 1 implanted IOL, as implanted. Note: 3 subjects randomized to Multifocal received Monofocal instead, and 1 subject randomized to Monofocal received Multifocal.	1.0% 1/100 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship to the device. This reporting group includes all randomized subjects with at least 1 implanted IOL, as implanted. Note: 3 subjects randomized to Multifocal received Monofocal instead, and 1 subject randomized to Monofocal received Multifocal.
Eye disorders Lens dislocation	0.94% 1/106 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship to the device. This reporting group includes all randomized subjects with at least 1 implanted IOL, as implanted. Note: 3 subjects randomized to Multifocal received Monofocal instead, and 1 subject randomized to Monofocal received Multifocal.	0.00% 0/100 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship to the device. This reporting group includes all randomized subjects with at least 1 implanted IOL, as implanted. Note: 3 subjects randomized to Multifocal received Monofocal instead, and 1 subject randomized to Monofocal received Multifocal.
Eye disorders Photophobia	0.00% 0/106 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship to the device. This reporting group includes all randomized subjects with at least 1 implanted IOL, as implanted. Note: 3 subjects randomized to Multifocal received Monofocal instead, and 1 subject randomized to Monofocal received Multifocal.	1.0% 1/100 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship to the device. This reporting group includes all randomized subjects with at least 1 implanted IOL, as implanted. Note: 3 subjects randomized to Multifocal received Monofocal instead, and 1 subject randomized to Monofocal received Multifocal.
Eye disorders Posterior capsular opacification	1.9% 2/106 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship to the device. This reporting group includes all randomized subjects with at least 1 implanted IOL, as implanted. Note: 3 subjects randomized to Multifocal received Monofocal instead, and 1 subject randomized to Monofocal received Multifocal.	0.00% 0/100 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship to the device. This reporting group includes all randomized subjects with at least 1 implanted IOL, as implanted. Note: 3 subjects randomized to Multifocal received Monofocal instead, and 1 subject randomized to Monofocal received Multifocal.
Eye disorders Retinal detachment	0.00% 0/106 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship to the device. This reporting group includes all randomized subjects with at least 1 implanted IOL, as implanted. Note: 3 subjects randomized to Multifocal received Monofocal instead, and 1 subject randomized to Monofocal received Multifocal.	1.0% 1/100 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship to the device. This reporting group includes all randomized subjects with at least 1 implanted IOL, as implanted. Note: 3 subjects randomized to Multifocal received Monofocal instead, and 1 subject randomized to Monofocal received Multifocal.
Eye disorders Retinal tear	0.94% 1/106 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship to the device. This reporting group includes all randomized subjects with at least 1 implanted IOL, as implanted. Note: 3 subjects randomized to Multifocal received Monofocal instead, and 1 subject randomized to Monofocal received Multifocal.	0.00% 0/100 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship to the device. This reporting group includes all randomized subjects with at least 1 implanted IOL, as implanted. Note: 3 subjects randomized to Multifocal received Monofocal instead, and 1 subject randomized to Monofocal received Multifocal.
Eye disorders Vitreous detachment	0.00% 0/106 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship to the device. This reporting group includes all randomized subjects with at least 1 implanted IOL, as implanted. Note: 3 subjects randomized to Multifocal received Monofocal instead, and 1 subject randomized to Monofocal received Multifocal.	1.0% 1/100 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship to the device. This reporting group includes all randomized subjects with at least 1 implanted IOL, as implanted. Note: 3 subjects randomized to Multifocal received Monofocal instead, and 1 subject randomized to Monofocal received Multifocal.
Eye disorders Vitreous loss	0.94% 1/106 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship to the device. This reporting group includes all randomized subjects with at least 1 implanted IOL, as implanted. Note: 3 subjects randomized to Multifocal received Monofocal instead, and 1 subject randomized to Monofocal received Multifocal.	0.00% 0/100 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship to the device. This reporting group includes all randomized subjects with at least 1 implanted IOL, as implanted. Note: 3 subjects randomized to Multifocal received Monofocal instead, and 1 subject randomized to Monofocal received Multifocal.
Eye disorders Vitritis	0.00% 0/106 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship to the device. This reporting group includes all randomized subjects with at least 1 implanted IOL, as implanted. Note: 3 subjects randomized to Multifocal received Monofocal instead, and 1 subject randomized to Monofocal received Multifocal.	1.0% 1/100 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship to the device. This reporting group includes all randomized subjects with at least 1 implanted IOL, as implanted. Note: 3 subjects randomized to Multifocal received Monofocal instead, and 1 subject randomized to Monofocal received Multifocal.
Gastrointestinal disorders Intestinal functional disorder	0.94% 1/106 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship to the device. This reporting group includes all randomized subjects with at least 1 implanted IOL, as implanted. Note: 3 subjects randomized to Multifocal received Monofocal instead, and 1 subject randomized to Monofocal received Multifocal.	0.00% 0/100 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship to the device. This reporting group includes all randomized subjects with at least 1 implanted IOL, as implanted. Note: 3 subjects randomized to Multifocal received Monofocal instead, and 1 subject randomized to Monofocal received Multifocal.
General disorders Device material issue	0.00% 0/106 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship to the device. This reporting group includes all randomized subjects with at least 1 implanted IOL, as implanted. Note: 3 subjects randomized to Multifocal received Monofocal instead, and 1 subject randomized to Monofocal received Multifocal.	1.0% 1/100 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship to the device. This reporting group includes all randomized subjects with at least 1 implanted IOL, as implanted. Note: 3 subjects randomized to Multifocal received Monofocal instead, and 1 subject randomized to Monofocal received Multifocal.
Infections and infestations Endophthalmitis	0.94% 1/106 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship to the device. This reporting group includes all randomized subjects with at least 1 implanted IOL, as implanted. Note: 3 subjects randomized to Multifocal received Monofocal instead, and 1 subject randomized to Monofocal received Multifocal.	0.00% 0/100 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship to the device. This reporting group includes all randomized subjects with at least 1 implanted IOL, as implanted. Note: 3 subjects randomized to Multifocal received Monofocal instead, and 1 subject randomized to Monofocal received Multifocal.
Injury, poisoning and procedural complications Eye operation complication	0.00% 0/106 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship to the device. This reporting group includes all randomized subjects with at least 1 implanted IOL, as implanted. Note: 3 subjects randomized to Multifocal received Monofocal instead, and 1 subject randomized to Monofocal received Multifocal.	1.0% 1/100 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship to the device. This reporting group includes all randomized subjects with at least 1 implanted IOL, as implanted. Note: 3 subjects randomized to Multifocal received Monofocal instead, and 1 subject randomized to Monofocal received Multifocal.
Investigations Intraocular pressure increased	0.94% 1/106 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship to the device. This reporting group includes all randomized subjects with at least 1 implanted IOL, as implanted. Note: 3 subjects randomized to Multifocal received Monofocal instead, and 1 subject randomized to Monofocal received Multifocal.	0.00% 0/100 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship to the device. This reporting group includes all randomized subjects with at least 1 implanted IOL, as implanted. Note: 3 subjects randomized to Multifocal received Monofocal instead, and 1 subject randomized to Monofocal received Multifocal.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemia	0.94% 1/106 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship to the device. This reporting group includes all randomized subjects with at least 1 implanted IOL, as implanted. Note: 3 subjects randomized to Multifocal received Monofocal instead, and 1 subject randomized to Monofocal received Multifocal.	0.00% 0/100 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship to the device. This reporting group includes all randomized subjects with at least 1 implanted IOL, as implanted. Note: 3 subjects randomized to Multifocal received Monofocal instead, and 1 subject randomized to Monofocal received Multifocal.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/106 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship to the device. This reporting group includes all randomized subjects with at least 1 implanted IOL, as implanted. Note: 3 subjects randomized to Multifocal received Monofocal instead, and 1 subject randomized to Monofocal received Multifocal.	1.0% 1/100 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship to the device. This reporting group includes all randomized subjects with at least 1 implanted IOL, as implanted. Note: 3 subjects randomized to Multifocal received Monofocal instead, and 1 subject randomized to Monofocal received Multifocal.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroma	0.00% 0/106 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship to the device. This reporting group includes all randomized subjects with at least 1 implanted IOL, as implanted. Note: 3 subjects randomized to Multifocal received Monofocal instead, and 1 subject randomized to Monofocal received Multifocal.	1.0% 1/100 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship to the device. This reporting group includes all randomized subjects with at least 1 implanted IOL, as implanted. Note: 3 subjects randomized to Multifocal received Monofocal instead, and 1 subject randomized to Monofocal received Multifocal.
Renal and urinary disorders Nephrolithiasis	0.94% 1/106 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship to the device. This reporting group includes all randomized subjects with at least 1 implanted IOL, as implanted. Note: 3 subjects randomized to Multifocal received Monofocal instead, and 1 subject randomized to Monofocal received Multifocal.	0.00% 0/100 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship to the device. This reporting group includes all randomized subjects with at least 1 implanted IOL, as implanted. Note: 3 subjects randomized to Multifocal received Monofocal instead, and 1 subject randomized to Monofocal received Multifocal.
Respiratory, thoracic and mediastinal disorders Chronic pulmonary obstructive disease	0.00% 0/106 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship to the device. This reporting group includes all randomized subjects with at least 1 implanted IOL, as implanted. Note: 3 subjects randomized to Multifocal received Monofocal instead, and 1 subject randomized to Monofocal received Multifocal.	1.0% 1/100 • An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship to the device. This reporting group includes all randomized subjects with at least 1 implanted IOL, as implanted. Note: 3 subjects randomized to Multifocal received Monofocal instead, and 1 subject randomized to Monofocal received Multifocal.