Pilot Study of AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens (IOL)

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL

• Registration Number: NCT01200511
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to describe visual outcomes, in particular spherical equivalent by manifest refraction and visual acuity across a range of distances, 6 months post implantation of the AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL in adult patients with corneal astigmatism. Additionally, patient reported outcomes will be assessed.

Detailed Description

Each subject completed a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 5 postoperative visits (each eye examined at Day 1-2, with binocular visits at Month 1, Month 3, and Month 6 after the second implantation). The second implantation generally occurred within 30 days of the first.

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-09-10
• Study First Submitted QC: 2010-09-10
• Study First Posted: 2010-09-13
• Primary Completion: 2011-09
• Study Completion: 2011-09
• 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: 49

Inclusion Criteria

• Sign informed consent;
• Require cataract extraction followed by posterior IOL implantation or eligible for refractive lens exchange (RLE) in both eyes;
• Able to undergo second eye surgery within one month (30 days) of first eye surgery;
• Able to attend postoperative examinations per protocol schedule;
• Qualify for a AcrySof IQ Toric IOL in both eyes;
• Preoperative astigmatism of ≥0.75 to ≤2.5 diopters (D) in both eyes;
• Residual refractive cylinder of ≤0.5 D in both eyes;
• Good ocular health;
• Other protocol-defined inclusion criteria may apply.

Read More

Exclusion Criteria

• Planned multiple procedures, including LRI, during cataract/IOL implantation surgery;
• Amblyopia;
• Previous corneal surgery;
• Clinically significant corneal endothelial dystrophy;
• History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.);
• History of retinal detachment;
• Pregnant or planning to become pregnant during course of study;
• Other protocol-defined exclusion criteria may apply.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ReSTOR +3.0	AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL	AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation

Primary Outcome Measures

Name	Time	Method
Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 6	Month 6 from second eye implantation	VA was tested binocularly 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.
Proportion of Subjects That Achieved Spherical Equivalent Within ± 0.5D, ± 0.75D, and ± 1.0D at Month 6	Month 6 from second eye implantation	Manifest refraction was performed under well-lit conditions using an ETDRS chart. The subject was manually refracted to his/her best correction by an outcomes assessor using a phoropter or trial lenses. Manifest refraction was performed for each eye. Proportion of subjects that achieved spherical equivalent within ± 0.5D/ ± 0.75D/ ± 1.0D at Month 6 is reported as percentage of subjects.
Uncorrected Visual Acuity Across a Range of Distances at Month 6	Month 6 from second eye implantation	Visual acuity (VA) was tested binocularly (both eyes together) 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.

Secondary Outcome Measures

Name	Time	Method
Patient Reported Outcomes at Month 6	Month 6 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. Distance specific tasks were rated (without / with corrective aids) 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.