Clinical Investigation of AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens (IOL)
|ClinicalTrials.gov Identifier: NCT01424189|
Recruitment Status : Completed
First Posted : August 26, 2011
Results First Posted : March 6, 2017
Last Update Posted : April 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cataracts||Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Device: AcrySof® ReSTOR® Multifocal IOL Model SA60D3||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||677 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Investigation of AcrySof® IQ ReSTOR® Multifocal Toric Intraocular Lens Models SND1T3/ SND1T4/ SND1T5/ SND1T6|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
Experimental: ReSTOR Toric IOL
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
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 Name: Models SND1T3, SND1T4, SND1T5, SND1T6
Active Comparator: ReSTOR IOL
AcrySof® ReSTOR® Multifocal IOL Model SA60D3, bilateral implantation
Device: AcrySof® ReSTOR® Multifocal IOL Model SA60D3
Multifocal IOL with extended secondary focal point implanted for long-term use over the lifetime of the cataract patient
- Mean Monocular Uncorrected Distance Visual Acuity (UCDVA) at Fixed Distance at Visit 5 [ Time Frame: Month 12 from second eye implantation ]Visual acuity (VA) was measured monocularly (each eye separately) without visual correction using a 100% contrast ETDRS (Early Treatment of Diabetic Retinopathy Study) chart positioned 4 meters (m) from the participant under well-lit conditions. +0.25 diopter (D) spherical power was applied to correct for optical infinity. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.
- Mean Monocular Uncorrected Near Visual Acuity (UCNVA) at Fixed Distance at Visit 5 [ Time Frame: Month 12 from second eye implantation ]VA was measured monocularly without visual correction using a hand-held ETDRS chart at a fixed distance that differed by lens model implanted. The logMAR ETDRS near visual acuity chart was designed for use at 40 cm; results obtained at other distances were converted to reflect the change in apparent letter size that results from the change in distance. VA was measured in 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. This analysis was prespecified for the first operative eye.
- Rate of Actual and Potential Secondary Surgical Interventions (SSIs) Related to the Optical Properties of the IOL for First and Second Operative Eyes Separately at Visit 5 [ Time Frame: Month 12 from second eye implantation ]The rate of actual and potential secondary surgical interventions (SSIs) related to the optical properties of the IOL was estimated. If an ocular surgical intervention was performed, it qualified as an actual SSI; however; if the participant met the protocol-specified criteria that would warrant an SSI, but didn't actually undergo the SSI, it qualified as a potential SSI. Rate is presented as percentage of participants.
- Rate of Severe Visual Disturbances/Distortions Reported on the Assessment of Photic Phenomena & Lens EffectS (APPLES) Questionnaire at Visit 5 [ Time Frame: Month 12 from second eye implantation ]Visual disturbances/distortions were reported by the participant on the Assessment of Photic Phenomena and Lens EffectS (APPLES) questionnaire, a Patient Reported Outcome (PRO) questionnaire intended to evaluate 10 distinct visual phenomena associated with cataract extraction and IOL implantation. The first 20 questions addressed both the frequency and severity of the phenomena using a 4-point categorical scale ranging from "never" to "always" (frequency) or "none" to "severe" (severity). The final (21st) question indicated whether the participant answered the questions based on experiences with or without glasses. The participant completed the assessment as a retrospective analysis of the previous week. Rate is presented as the percentage of participants with severity score "severe" for the visual phenomenon.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01424189
|Study Director:||Expert Clinical Project Lead, GCRA, Surgical||Alcon Research|