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

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ClinicalTrials.gov Identifier: NCT01290068
Recruitment Status : Completed
First Posted : February 4, 2011
Results First Posted : March 6, 2017
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Cataract
Interventions Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL
Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL
Device: Monofocal IOL
Enrollment 208
Recruitment Details Participants were recruited from 20 investigative sites located in France (3), Germany (4), Great Britain (1), Italy (3), Netherlands (4), and Spain (5).
Pre-assignment Details This reporting group includes all randomized participants, as randomized.
Arm/Group Title Multifocal IOL Monofocal IOL
Hide Arm/Group Description AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation Monofocal IOL, bilateral implantation
Period Title: Overall Study
Started 108 100
Implanted 108 98
Completed 101 94
Not Completed 7 6
Reason Not Completed
Adverse Event             1             3
Lost to Follow-up             3             0
Withdrawal by subject prior to implant             0             2
Other             3             1
Arm/Group Title Multifocal IOL Monofocal IOL Total
Hide Arm/Group Description AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation Monofocal IOL, bilateral implantation Total of all reporting groups
Overall Number of Baseline Participants 108 98 206
Hide Baseline Analysis Population Description
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.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 108 participants 98 participants 206 participants
21 to 59 years 13 7 20
60 to 69 years 40 36 76
70 to 79 years 40 45 85
≥80 years 15 10 25
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 108 participants 98 participants 206 participants
Female
63
  58.3%
58
  59.2%
121
  58.7%
Male
45
  41.7%
40
  40.8%
85
  41.3%
1.Primary Outcome
Title Percentage of Participants Classified as Responders
Hide Description 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.
Time Frame Month 6 after second eye implantation
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Multifocal IOL Monofocal IOL
Hide Arm/Group Description:
AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation
Monofocal IOL, bilateral implantation
Overall Number of Participants Analyzed 105 97
Measure Type: Number
Unit of Measure: percentage of participants
45.7 2.1
2.Primary Outcome
Title Proportion of Participants Reporting Spectacle Independence at All Distances
Hide Description 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.
Time Frame Month 6 after second eye implantation
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Multifocal IOL Monofocal IOL
Hide Arm/Group Description:
AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation
Monofocal IOL, bilateral implantation
Overall Number of Participants Analyzed 101 95
Measure Type: Number
Unit of Measure: percentage of participants
73.3 25.3
3.Primary Outcome
Title Mean Vision-Related Quality of Life as Reported on the NEI-RQL 42 (5 Dimensions)
Hide Description 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.
Time Frame Month 6 after second eye implantation
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Multifocal IOL Monofocal IOL
Hide Arm/Group Description:
AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation
Monofocal IOL, bilateral implantation
Overall Number of Participants Analyzed 108 98
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Near vision Number Analyzed 100 participants 93 participants
87.63  (1.868) 83.57  (1.951)
Activity limitations Number Analyzed 99 participants 90 participants
95.19  (1.431) 94.85  (1.511)
Dependence on correction Number Analyzed 99 participants 92 participants
83.67  (3.512) 46.34  (3.686)
Appearance Number Analyzed 98 participants 90 participants
84.48  (2.723) 76.79  (2.875)
Satisfaction with correction Number Analyzed 98 participants 90 participants
84.81  (2.071) 82.40  (2.179)
4.Secondary Outcome
Title Median Total Spectacle Cost Prior to Any Reimbursement
Hide Description 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.
Time Frame Month 6 after second eye implantation
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Multifocal IOL Monofocal IOL
Hide Arm/Group Description:
AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation
Monofocal IOL, bilateral implantation
Overall Number of Participants Analyzed 101 95
Median (Inter-Quartile Range)
Unit of Measure: euros
0.00
(0.00 to 8.50)
85.729
(0.00 to 147.42)
Time Frame 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.
Adverse Event Reporting Description 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.
 
Arm/Group Title Multifocal IOL Monofocal IOL
Hide Arm/Group Description AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation Monofocal IOL, bilateral implantation
All-Cause Mortality
Multifocal IOL Monofocal IOL
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Multifocal IOL Monofocal IOL
Affected / at Risk (%) Affected / at Risk (%)
Total   13/106 (12.26%)   9/100 (9.00%) 
Cardiac disorders     
Cardiac disorder * 1  1/106 (0.94%)  0/100 (0.00%) 
Eye disorders     
Astigmatism * 1  1/106 (0.94%)  0/100 (0.00%) 
Corneal oedema * 1  1/106 (0.94%)  0/100 (0.00%) 
Cystoid macular oedema * 1  1/106 (0.94%)  0/100 (0.00%) 
Iridocele * 1  0/106 (0.00%)  1/100 (1.00%) 
Lens dislocation * 1  1/106 (0.94%)  0/100 (0.00%) 
Photophobia * 1  0/106 (0.00%)  1/100 (1.00%) 
Posterior capsular opacification * 1  2/106 (1.89%)  0/100 (0.00%) 
Retinal detachment * 1  0/106 (0.00%)  1/100 (1.00%) 
Retinal tear * 1  1/106 (0.94%)  0/100 (0.00%) 
Vitreous detachment * 1  0/106 (0.00%)  1/100 (1.00%) 
Vitreous loss * 1  1/106 (0.94%)  0/100 (0.00%) 
Vitritis * 1  0/106 (0.00%)  1/100 (1.00%) 
Gastrointestinal disorders     
Intestinal functional disorder * 1  1/106 (0.94%)  0/100 (0.00%) 
General disorders     
Device material issue * 1  0/106 (0.00%)  1/100 (1.00%) 
Infections and infestations     
Endophthalmitis * 1  1/106 (0.94%)  0/100 (0.00%) 
Injury, poisoning and procedural complications     
Eye operation complication * 1  0/106 (0.00%)  1/100 (1.00%) 
Investigations     
Intraocular pressure increased * 1  1/106 (0.94%)  0/100 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Leukaemia * 1  1/106 (0.94%)  0/100 (0.00%) 
Lung neoplasm malignant * 1  0/106 (0.00%)  1/100 (1.00%) 
Neuroma * 1  0/106 (0.00%)  1/100 (1.00%) 
Renal and urinary disorders     
Nephrolithiasis * 1  1/106 (0.94%)  0/100 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Chronic pulmonary obstructive disease * 1  0/106 (0.00%)  1/100 (1.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (14.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Multifocal IOL Monofocal IOL
Affected / at Risk (%) Affected / at Risk (%)
Total   0/106 (0.00%)   0/100 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
Name/Title: Brand Lead, Surgical, Global Medical Affairs
Organization: Alcon Research, Ltd.
Phone: 1-888-451-3937
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01290068     History of Changes
Other Study ID Numbers: RDG-10-269
First Submitted: February 3, 2011
First Posted: February 4, 2011
Results First Submitted: January 13, 2017
Results First Posted: March 6, 2017
Last Update Posted: July 2, 2018