VISUAL OUTCOMES AFTER BILATERAL SURGICAL CATARACT PHACOEMULSIFICATION: ACRYSOF® TORIC IOL IMPLANTATION COMPARED TO MONOFOCAL IOL IMPLANTATION.

Withdrawn

• Conditions: cataract; corneaal astigmatism; 10047518

• Registration Number: NL-OMON35005
• Lead Sponsor: Alcon Laboratories (U.K.) Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 146

Inclusion Criteria

Ocular criteria must be met in both eyes:
are >= 21 years of age;
have bilateral, age related, cataracts;
have planned cataract removal via phacoemulsification with implantation of an 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;
-As indicated in the *Precautions* section of the AcrySof Toric and monofocal package inserts, potential subjects should exhibit a favorable preoperative benefit/risk ratio for lens implantation, in the surgeons medical judgment, when one or more of the following conditions exists: 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, color vision deficiencies, corneal endothelial disease, abnormal cornea, macular or retinal degeneration or chronic drug miosis,
qualify for bilateral AcrySof Toric IOLs on the AcrySof Toric Calculator;
have regular corneal astigmatism;
are able to obtain pupil dilation >= 5.0 mm.

Exclusion Criteria

If any of the following exclusion criteria are applicable to either eye, the subject should not be enrolled in the study:
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;;pregnant, lactating or planning pregnancy during course of study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified