VISUAL OUTCOMES AFTER BILATERAL SURGICAL CATARACT PHACOEMULSIFICATION: ACRYSOF® RESTOR IOL IMPLANTATION COMPARED TO MONOFOCAL IOL IMPLANTATIO

Completed

Conditions: cataract
corneaal astigmatism
10047518

Registration Number: NL-OMON36197

Lead Sponsor: Alcon Laboratories

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

Ocular criteria must be met in both eyes;
>= 21 years of age;
willing and able to attend postoperative examinations as per protocol schedule;
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;
fulfils the recommendations at the *Warnings* and *Precautions* sections of the AcrySof ReSTOR IOL and Monofocal IOL package inserts;
have either no pre-operative corneal astigmatism or pre-operative regular corneal astigmatism <=2.5D;
Both eyes qualify for either AcrySof ReSTOR IOL model SN6AD1 or AcrySof ReSTOR Toric IOLs models SND1T2-SND1T5 on the AcrySof IOL online calculator provide by the sponsor, as described at session 9.2.1 of the protocol 09dec2010.

Exclusion Criteria

If any of the following exclusion criteria are applicable to either eye, the subject shall 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, severe 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;

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>bilateral uncorrected distance visual acuity and bilateral uncorrected near<br /><br>visual acuity <= 0.1 logMar;<br /><br>Spectacle independence at all distances<br /><br>Vision-related quality of life</p><br>

Secondary Outcome Measures