Comperative Trial Between an Accommodative Iol and Monofocal Iol

Not Applicable

Withdrawn

• Conditions: CATARACT SURGERY
• Interventions: Device: Acrysof; Device: Acuity's AIOL

• Registration Number: NCT00604305
• Lead Sponsor: Shaare Zedek Medical Center

Brief Summary

a comparison of two intraocular lenses in regard of accommodative power.

Detailed Description

A new accommodating IOL (Acuity Ltd, Israel) will be compared with Alcon's Acrysof for 1 year for visual acuity and distance and near best corrected visual acuity.

Study Timeline

• Study First Submitted: 2008-01-17
• Study First Submitted QC: 2008-01-29
• Study First Posted: 2008-01-30
• Study Start: 2008-03
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-10
• Last Update Posted: 2012-06-12
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Age between 30 and 65
• Required cataract operation in one or both eyes
• BCVA potetial at least 20/30
• Clear intraoccular media
• Willing to participate in study as evidenced by signing a written Informed Consent

Exclusion Criteria

Main

• Prior surgery at the selected eye
• No light perception or poor potential for improvement
• Phacodonesis and damaged zonules
• Pupil size at least 6 mm.
• History of uveitis
• Macular disease decreasing vision below 20/30
• Amblyopia
• Axial length shorter than 21 mm and longer than 25 mm

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acrysof	Acrysof	Routine monofocal IOL
Acuity's AIOL	Acuity's AIOL	Accomodaing IOL

Primary Outcome Measures

Name	Time	Method
distance and near visual acuity	1 year

Secondary Outcome Measures

Name	Time	Method
centration pco	1 year