A Randomized, Subject-Masked Comparison of Visual Function After Bilateral Implantation of Presbyopia-Correcting IOLs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 31
- Primary Endpoint
- Mean Binocular Defocus VA at Month 3
Study Overview
Brief Summary
The purpose of this study is to evaluate visual and refractive parameters in a series of subjects bilaterally implanted with presbyopia-correcting intraocular lenses (IOLs) during cataract surgery.
Detailed Description
Each subject completed a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 4 postoperative visits (each eye examined at Day 1-2, with binocular visits at Month 1 and Month 3 after the second implantation). The second implantation occurred within 30 days of the first.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Sign informed consent;
- •Able to attend postoperative examinations per protocol schedule;
- •Diagnosed with bilateral cataracts;
- •Planned cataract removal by phacoemulsification with implantation of an intraocular lens (IOL);
- •Preoperative astigmatism ≤ 2.5 diopter;
- •Good ocular health, with the exception of cataracts;
- •Free of disease(s)/condition(s) listed in the "Caution" section of the AcrySof IQ and Acri.LISA package inserts;
- •Able to undergo second eye surgery within one month of the first eye surgery;
- •Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- •Previous corneal surgery;
- •Planned multiple procedures during cataract/IOL implantation surgery;
- •Any ocular disease and/or condition that may compromise study results;
- •Pregnant or planning pregnancy during course of study;
- •History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
- •Diabetic retinopathy;
- •Macular degeneration;
- •History of retinal detachment;
- •Other protocol-defined exclusion criteria may apply.
Arms & Interventions
ReSTOR +3
AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation
Intervention: AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 (Device)
ReSTOR +3
AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation
Intervention: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT (Device)
Acri.LISA
Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
Intervention: Acri.LISA® 366D IOL (Device)
Acri.LISA
Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
Intervention: Acri.LISA® 466TD Toric IOL (Device)
Outcomes
Primary Outcomes
Mean Binocular Defocus VA at Month 3
Time Frame: Month 3 from second eye implantation
Defocus VA (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly with the participant's best spectacle correction using a chart. Lenses of different spherical powers were placed in front of the eyes to produce varying levels of defocus. The VA at each spherical power was measured in logarithm of the minimum angle of resolution (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.
Secondary Outcomes
- Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 3(Month 3 from second eye implantation)
- Uncorrected Visual Acuity Across a Range of Distances at Month 3(Month 3 from second eye implantation)
- Mean Refractive Spherical Equivalent at Month 3(Month 3 from second eye implantation)
- Mean Radner Reading Speed(Month 3 from second eye implantation)
- Patient Reported Outcomes at Month 3(Month 3 from second eye implantation)