Visual Outcomes After Bilateral Surgical Cataract Phacoemulsification: AcrySof Toric Intraocular Lens (IOL) Implantation Compared to Monofocal IOL Implantation

Alcon Research1 site in 1 country9 target enrollmentJune 2010

ConditionsCataract

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Cataract
Sponsor: Alcon Research
Enrollment: 9
Locations: 1
Primary Endpoint: Uncorrected Distance Visual Acuity
Status: Terminated
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objectives of this study are to assess and compare bilateral uncorrected distance visual acuity and distance spectacle independence post bilateral implantation of AcrySof Toric Intraocular Lenses (IOLs) and monofocal IOLs. Secondary outcomes will include cost of eyeglass purchased and patient vision-related quality of life.

Registry

clinicaltrials.gov

Start Date

June 2010

End Date

December 2010

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Alcon Research

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•are willing and able to understand and sign an informed consent;
•are willing and able to attend postoperative examinations per protocol schedule;
•are ≥ 21 years of age, of either gender and any race;
•have bilateral, age related, cataracts;
•have planned cataract removal via phacoemulsification with implantation of an intraocular lens (IOL);
•are available to undergo second eye surgery within 6 weeks of the first eye surgery;
•are in good ocular health, with the exception of cataracts;
•are free of disease(s)/condition(s) listed in the "Precautions" section of the AcrySof Toric and monofocal package inserts: choroidal hemorrhage, chronic severe uveitis, concomitant severe eye disease, extremely shallow anterior chamber, medically uncontrolled glaucoma, microphthalmos, non-age-related cataract, proliferative diabetic retinopathy (severe), severe corneal dystrophy, severe optic nerve atrophy, irregular corneal astigmatism and color vision deficiencies.
•have regular corneal astigmatism;
•qualify for bilateral AcrySof Toric IOLs on the AcrySof Toric Calculator (www.acrysoftoriccalculator.com)

Exclusion Criteria

•previous corneal surgery and/or reshaping
•abnormality, disease and/or conditions of the cornea (i.e. keratoconus, corneal dystrophy, keratitis, corneal scar, etc.), which would clinically contra-indicate the implantation of a toric intraocular lens
•planned multiple procedures during cataract/IOL implantation surgery
•planned limbal relaxing incision (LRI), Excimer laser treatment or similar procedure prior to or during the course of the study
•an ocular disease and/or condition that may compromise visual acuity levels (i.e. glaucoma, diabetic retinopathy, amblyopia, etc.)
•pregnant, lactating or planning pregnancy during course of study. Subjects who become pregnant during the study will not be discontinued; however, data may be excluded from the effectiveness analyses because pregnancy can alter refraction and visual acuity results. Data will be collected on the CRF as observations.

Outcomes

Primary Outcomes

Uncorrected Distance Visual Acuity

Time Frame: 6 Months After Surgery

Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.

Spectacle Independence

Time Frame: 6 Months After Surgery

Spectacle Independence (the ability of the patient to go without corrective lenses) measured by a subjective patient questionnaire.