Visual Outcomes After Cataract Surgery: Multifocal AcrySof® IQ ReSTOR® Intraocular Lenses Versus Monofocal Intraocular Lenses
Study Details
Study Description
Brief Summary
The purpose of this study is to assess and compare visual outcomes of the AcrySof® IQ ReSTOR® +3.0 D intraocular lens (IOL) to a commercially available monofocal IOL in cataract patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This study included subjects with bilateral age-related cataracts and either no preoperative corneal astigmatism, or preoperative regular corneal astigmatism confirmed by autokeratometry of ≤2.5 D.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ReSTOR +3 AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, bilateral implantation |
Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL
Multifocal IOL with extended secondary focal point implanted for long-term use over the lifetime of the cataract patient
Other Names:
|
| Experimental: ReSTOR +3 Toric AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative corneal astigmatism, bilateral implantation, or implanted in 1 eye with AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL in the other eye |
Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL
Multifocal IOL with extended secondary focal point implanted for long-term use over the lifetime of the cataract patient
Other Names:
Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL
Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient
Other Names:
|
| Active Comparator: Monofocal Monofocal IOL, bilateral implantation |
Device: Monofocal IOL
Monofocal IOL implanted for long-term use over the lifetime of the cataract patient
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants Classified as Responders [Month 6 after second eye implantation]
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.
- Proportion of Participants Reporting Spectacle Independence at All Distances [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.
- Mean Vision-Related Quality of Life as Reported on the NEI-RQL 42 (5 Dimensions) [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.
Secondary Outcome Measures
- Median Total Spectacle Cost Prior to Any Reimbursement [Month 6 after second eye implantation]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Willing and able to understand and sign an Informed Consent;
-
Willing and able to attend post-operative examinations as per protocol schedule;
-
Diagnosis of bilateral, age-related cataracts;
-
Planned cataract removal via phacoemulsification with implantation of an IOL;
-
Available to undergo second eye surgery within 6 weeks of the first eye surgery;
-
Fulfill the recommendations of the "Warnings" and "Precautions" sections of the AcrySof IQ ReSTOR IOL and Monofocal IOL package inserts;
-
No preoperative corneal astigmatism or preoperative regular corneal astigmatism ≤2.5D;
-
Qualify in both eyes for either AcrySof® IQ ReSTOR® IOL Model SN6AD1 or AcrySof® IQ ReSTOR® Toric IOL Models SND1T2 through SND1T5 as indicated by the AcrySof IQ ReSTOR Multifocal Toric web-based calculator;
-
Able to read and understand one of the following languages: Dutch, French, German, Italian, Spanish, English or Catalan.
-
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
-
Previous corneal surgery and/or reshaping;
-
Any abnormality, disease and/or conditions of the cornea (ie, keratoconus, corneal dystrophy, severe keratitis, corneal scar, etc.), which would clinically contraindicate the implantation of a toric IOL;
-
Planned multiple procedures during cataract/IOL implantation surgery;
-
Planned limbal relaxing incisions, excimer laser treatment or similar procedures prior to or during the course of the study;
-
Pregnant, lactating, or planning pregnancy during the course of study;
-
Other protocol-defined exclusion criteria may apply.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Alcon Research
Investigators
- Study Director: Brand Lead, Surgical, Global Medical Affairs, Alcon Research
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RDG-10-269
Study Results
Participant Flow
| 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 Detail | This reporting group includes all randomized participants, as randomized. |
| Arm/Group Title | Multifocal IOL | Monofocal IOL |
|---|---|---|
| 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 |
Baseline Characteristics
| Arm/Group Title | Multifocal IOL | Monofocal IOL | Total |
|---|---|---|---|
| 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 Participants | 108 | 98 | 206 |
| Age, Customized (participants) [Number] | |||
| 21 to 59 years |
13
12%
|
7
7.1%
|
20
9.7%
|
| 60 to 69 years |
40
37%
|
36
36.7%
|
76
36.9%
|
| 70 to 79 years |
40
37%
|
45
45.9%
|
85
41.3%
|
| ≥80 years |
15
13.9%
|
10
10.2%
|
25
12.1%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
63
58.3%
|
58
59.2%
|
121
58.7%
|
| Male |
45
41.7%
|
40
40.8%
|
85
41.3%
|
Outcome Measures
| Title | Percentage of Participants Classified as Responders |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| Arm/Group Description | AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation | Monofocal IOL, bilateral implantation |
| Measure Participants | 105 | 97 |
| Number [percentage of participants] |
45.7
42.3%
|
2.1
2.1%
|
| Title | Proportion of Participants Reporting Spectacle Independence at All Distances |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| Arm/Group Description | AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation | Monofocal IOL, bilateral implantation |
| Measure Participants | 101 | 95 |
| Number [percentage of participants] |
73.3
67.9%
|
25.3
25.8%
|
| Title | Mean Vision-Related Quality of Life as Reported on the NEI-RQL 42 (5 Dimensions) |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| Arm/Group Description | AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation | Monofocal IOL, bilateral implantation |
| Measure Participants | 108 | 98 |
| Near vision |
87.63
(1.868)
|
83.57
(1.951)
|
| Activity limitations |
95.19
(1.431)
|
94.85
(1.511)
|
| Dependence on correction |
83.67
(3.512)
|
46.34
(3.686)
|
| Appearance |
84.48
(2.723)
|
76.79
(2.875)
|
| Satisfaction with correction |
84.81
(2.071)
|
82.40
(2.179)
|
| Title | Median Total Spectacle Cost Prior to Any Reimbursement |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| Arm/Group Description | AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation | Monofocal IOL, bilateral implantation |
| Measure Participants | 101 | 95 |
| Median (Inter-Quartile Range) [euros] |
0.00
|
85.729
|
Adverse Events
| 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 | ||
| 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 (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Multifocal IOL | Monofocal IOL | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 13/106 (12.3%) | 9/100 (9%) | ||
| Cardiac disorders | ||||
| Cardiac disorder | 1/106 (0.9%) | 0/100 (0%) | ||
| Eye disorders | ||||
| Astigmatism | 1/106 (0.9%) | 0/100 (0%) | ||
| Corneal oedema | 1/106 (0.9%) | 0/100 (0%) | ||
| Cystoid macular oedema | 1/106 (0.9%) | 0/100 (0%) | ||
| Iridocele | 0/106 (0%) | 1/100 (1%) | ||
| Lens dislocation | 1/106 (0.9%) | 0/100 (0%) | ||
| Photophobia | 0/106 (0%) | 1/100 (1%) | ||
| Posterior capsular opacification | 2/106 (1.9%) | 0/100 (0%) | ||
| Retinal detachment | 0/106 (0%) | 1/100 (1%) | ||
| Retinal tear | 1/106 (0.9%) | 0/100 (0%) | ||
| Vitreous detachment | 0/106 (0%) | 1/100 (1%) | ||
| Vitreous loss | 1/106 (0.9%) | 0/100 (0%) | ||
| Vitritis | 0/106 (0%) | 1/100 (1%) | ||
| Gastrointestinal disorders | ||||
| Intestinal functional disorder | 1/106 (0.9%) | 0/100 (0%) | ||
| General disorders | ||||
| Device material issue | 0/106 (0%) | 1/100 (1%) | ||
| Infections and infestations | ||||
| Endophthalmitis | 1/106 (0.9%) | 0/100 (0%) | ||
| Injury, poisoning and procedural complications | ||||
| Eye operation complication | 0/106 (0%) | 1/100 (1%) | ||
| Investigations | ||||
| Intraocular pressure increased | 1/106 (0.9%) | 0/100 (0%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Leukaemia | 1/106 (0.9%) | 0/100 (0%) | ||
| Lung neoplasm malignant | 0/106 (0%) | 1/100 (1%) | ||
| Neuroma | 0/106 (0%) | 1/100 (1%) | ||
| Renal and urinary disorders | ||||
| Nephrolithiasis | 1/106 (0.9%) | 0/100 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Chronic pulmonary obstructive disease | 0/106 (0%) | 1/100 (1%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Multifocal IOL | Monofocal IOL | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/106 (0%) | 0/100 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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 |
| alcon.medinfo@alcon.com |
- RDG-10-269