Cataract
Conditions
Keywords
Intraocular Lens
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.
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.
Interventions
DEVICEAcrySof® 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
Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient
DEVICEMonofocal IOL
Monofocal IOL implanted for long-term use over the lifetime of the cataract patient
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
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 details
This reporting group includes all randomized participants, as randomized.
Participants by arm
| Arm | Count |
|---|---|
| Multifocal IOL AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation | 108 |
| Monofocal IOL Monofocal IOL, bilateral implantation | 98 |
| Total | 206 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 3 |
| Overall Study | Lost to Follow-up | 3 | 0 |
| Overall Study | Other | 3 | 1 |
| Overall Study | Withdrawal by subject prior to implant | 0 | 2 |
Baseline characteristics
| Characteristic | Multifocal IOL | Monofocal IOL | Total |
|---|---|---|---|
| Age, Customized 21 to 59 years | 13 participants | 7 participants | 20 participants |
| Age, Customized 60 to 69 years | 40 participants | 36 participants | 76 participants |
| Age, Customized 70 to 79 years | 40 participants | 45 participants | 85 participants |
| Age, Customized ≥80 years | 15 participants | 10 participants | 25 participants |
| Sex: Female, Male Female | 63 Participants | 58 Participants | 121 Participants |
| Sex: Female, Male Male | 45 Participants | 40 Participants | 85 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 106 | 0 / 100 |
| serious Total, serious adverse events | 13 / 106 | 9 / 100 |
Outcome results
Primary
Mean Vision-Related Quality of Life as Reported on the NEI-RQL 42 (5 Dimensions)
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
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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Multifocal IOL | 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 |
| Multifocal IOL | 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 |
| Multifocal IOL | 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 |
| Multifocal IOL | 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 |
| Multifocal IOL | 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 |
| Monofocal IOL | Mean Vision-Related Quality of Life as Reported on the NEI-RQL 42 (5 Dimensions) | Dependence on correction | 46.34 units on a scale | Standard Error 3.686 |
| Monofocal IOL | Mean Vision-Related Quality of Life as Reported on the NEI-RQL 42 (5 Dimensions) | Near vision | 83.57 units on a scale | Standard Error 1.951 |
| Monofocal IOL | Mean Vision-Related Quality of Life as Reported on the NEI-RQL 42 (5 Dimensions) | Activity limitations | 94.85 units on a scale | Standard Error 1.511 |
| Monofocal IOL | Mean Vision-Related Quality of Life as Reported on the NEI-RQL 42 (5 Dimensions) | Appearance | 76.79 units on a scale | Standard Error 2.875 |
| Monofocal IOL | Mean Vision-Related Quality of Life as Reported on the NEI-RQL 42 (5 Dimensions) | Satisfaction with correction | 82.40 units on a scale | Standard Error 2.179 |
Primary
Percentage of Participants Classified as Responders
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Multifocal IOL | Percentage of Participants Classified as Responders | 45.7 percentage of participants |
| Monofocal IOL | Percentage of Participants Classified as Responders | 2.1 percentage of participants |
Primary
Proportion of Participants Reporting Spectacle Independence at All Distances
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Multifocal IOL | Proportion of Participants Reporting Spectacle Independence at All Distances | 73.3 percentage of participants |
| Monofocal IOL | Proportion of Participants Reporting Spectacle Independence at All Distances | 25.3 percentage of participants |
Secondary
Median Total Spectacle Cost Prior to Any Reimbursement
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
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Multifocal IOL | Median Total Spectacle Cost Prior to Any Reimbursement | 0.00 euros |
| Monofocal IOL | Median Total Spectacle Cost Prior to Any Reimbursement | 85.729 euros |