Comperative Trial Between an Accommodative Iol and Monofocal Iol

• Sponsor: Shaare Zedek Medical Center (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT00604305
• Collaborator: (none)
• Enrollment: 0
• Arms: 2
• Duration (Months): 57

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
CATARACT SURGERY	Device: Acrysof; Device: Acuity's AIOL	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Single Blind Comparative Study of the Acuity's C-Well Accommodating Intra Occular Lens (AIOL) Against Alcon's Acrysof
• Study Start Date: Mar 1, 2008
• Anticipated Primary Completion Date: Dec 1, 2012
• Anticipated Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Acrysof Routine monofocal IOL	Device: Acrysof; Monofocal IOL
Active Comparator: Acuity's AIOL Accomodaing IOL	Device: Acuity's AIOL; Accommodating IOL

Outcome Measures

Primary Outcome Measures

1. distance and near visual acuity [1 year]

Secondary Outcome Measures

1. centration pco [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Shaare Zedek Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Yaacov Rozenman, Head of eye department, Shaare Zedek Medical Center
• ClinicalTrials.gov Identifier: NCT00604305
• Other Study ID Numbers: 6666476CTIL; Rozenman-CWPMS001
• First Posted: Jan 30, 2008
• Last Update Posted: Jun 12, 2012
• Last Verified: Jun 1, 2012

• Additional relevant MeSH terms: Cataract

Study Results

No Results Posted as of Jun 12, 2012