A Comparison of Visual Function After Bilateral Implantation of Presbyopia-Correcting Intraocular Lenses (IOLs)

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Device: Acri.LISA® 366D IOL; Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1; Device: Acri.LISA® 466TD Toric IOL; Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT

• Registration Number: NCT01257217
• Lead Sponsor: Alcon Research

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-12-08
• Study First Submitted QC: 2010-12-08
• Study First Posted: 2010-12-09
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Results First Submitted: 2017-01-13
• Status Verified: 2017-03
• Results First Submitted QC: 2017-03-09
• Results First Posted: 2017-04-20
• Last Update Submitted: 2018-05-31
• Last Update Posted: 2018-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acri.LISA	Acri.LISA® 366D IOL	Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
Acri.LISA	Acri.LISA® 466TD Toric IOL	Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
ReSTOR +3	AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1	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
ReSTOR +3	AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT	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

Primary Outcome Measures

Name	Time	Method
Mean Binocular Defocus VA at Month 3	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 Outcome Measures

Name	Time	Method
Patient Reported Outcomes at Month 3	Month 3 from second eye implantation	The Visual Task Difficulty Assessment (VISTAS) questionnaire was completed by the subject to assess difficulty in completing everyday tasks that depend on good vision. Tasks were rated using a 1 to 5 point scale, where 1 = no difficulty; 2 = minor difficulty; 3 = moderate difficulty; 4 = major difficulty; 5 = cannot accomplish. Individual scores for each task were averaged to obtain the overall score for each vision type/function. Near vision was defined as less than 50 cm; intermediate vision as 50 cm to 1 m; extended intermediate vision as 90 cm to 4 m; and distant vision as more than 4 m.
Mean Refractive Spherical Equivalent at Month 3	Month 3 from second eye implantation	A manifest refraction (vision check) was performed using a 100% contrast ETDRS chart under well-lit conditions. Results were documented for sphere, cylinder and axis readings. The refractive spherical equivalent was calculated according to the formula: sphere + ½ cylinder power. Both eyes contributed to the mean.
Mean Radner Reading Speed	Month 3 from second eye implantation	Reading performance was measured using the Radner Reading Chart with no correction (without) and with best distance corrective aids (with). Reading speed was measured in words per minute.
Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 3	Month 3 from second eye implantation	Visual acuity (VA) was tested binocularly (both eyes together) with correction in place if needed across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. VA 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.
Uncorrected Visual Acuity Across a Range of Distances at Month 3	Month 3 from second eye implantation	VA was tested binocularly unaided across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. VA 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.