Comperative Trial Between an Accommodative Iol and Monofocal Iol

June 10, 2012 updated by: Dr. Yaacov Rozenman, Shaare Zedek Medical Center

A Randomized Single Blind Comparative Study of the Acuity's C-Well Accommodating Intra Occular Lens (AIOL) Against Alcon's Acrysof

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
distance and near visual acuity
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
centration pco
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaare Zedek Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

January 17, 2008

First Submitted That Met QC Criteria

January 29, 2008

First Posted (Estimate)

January 30, 2008

Study Record Updates

Last Update Posted (Estimate)

June 12, 2012

Last Update Submitted That Met QC Criteria

June 10, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6666476CTIL
  • Rozenman-CWPMS001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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