Visual Outcomes After Bilateral Surgical Cataract Phacoemulsification: AcrySof Toric IOL Implantation Compared to Monofocal IOL Implantation

Phase 4

Terminated

• Conditions: Cataract
• Interventions: Device: Monofocal; Device: Toric T3 - T9

• Registration Number: NCT01192321
• Lead Sponsor: Alcon Research

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-08-30
• Study First Submitted QC: 2010-08-30
• Study First Posted: 2010-09-01
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-19
• Last Update Posted: 2012-10-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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)
• are able to obtain pupil dilation ≥ 5.0 mm
• are able to read and understand one of the following languages: Dutch, French, German

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Monofocal	Monofocal	Bilateral implantation of a monofocal intraocular lens (IOL) model with no toric component.
Toric T3 - T9	Toric T3 - T9	Bilateral implantation of a Toric intraocular lens (IOL) models T3, T4, T5, T6, T7, T8 or T9

Primary Outcome Measures

Name	Time	Method
Uncorrected Distance Visual Acuity	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	6 Months After Surgery	Spectacle Independence (the ability of the patient to go without corrective lenses) measured by a subjective patient questionnaire.

Secondary Outcome Measures

Name	Time	Method
Vision-related Quality of Life	6 Months After Surgery	Vision related quality of life as measured by a subjective subject questionnaire.

Trial Locations

Locations (1)

Contact Alcon Call Center for Trial Locations; 🇫🇷 Paris, France