Effect of Optic Edge Design in a Silicone Intraocular Lens on Posterior Capsule Opacification

January 29, 2007 updated by: Medical University of Vienna

Purpose: To compare the posterior capsule opacification (PCO) inhibiting effect of the sharp posterior optic edge design of the Clariflex silicone intraocular lens (IOL) with that of the double-round edge design of the SI40 (Phacoflex) silicone IOL over a period of 3 years.

Setting: Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.

Methods: Fifty-two patients with bilateral age-related cataract (104 eyes) were included in this randomized, prospective, bilateral, patient- and examiner-masked clinical trial with intra-individual comparison. Each study patient had cataract surgery in both eyes and received an SI40 IOL (anterior and posterior round optic edges) in one eye and a Clariflex IOL with OptiEdge (round anterior and sharp posterior optic edge) in the other eye. Follow-up examinations were at one week, one month, six months, one, two, and three years. Digital retroillumination images were taken of each eye. The amount of PCO was assessed subjectively at the slit-lamp and objectively using automated image analysis software (AQUA) one, two, and three years after surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

52

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Dept. of Ophthalmology, Medical University of Vienna

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

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • bilateral, age related cataract

Exclusion Criteria:

  • history of other ocular disease or intraocular surgery
  • diabetes requiring medical control

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
amount of posterior capsule opacification (objective and subjective score 0-10)

Secondary Outcome Measures

Outcome Measure
visual acuity

Collaborators and Investigators

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

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Rupert Menapace, MD, Medical University of Vienna
  • Principal Investigator: Oliver Findl, MD, Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

June 1, 2001

Study Completion

March 1, 2006

Study Registration Dates

First Submitted

January 29, 2007

First Submitted That Met QC Criteria

January 29, 2007

First Posted (Estimate)

January 30, 2007

Study Record Updates

Last Update Posted (Estimate)

January 30, 2007

Last Update Submitted That Met QC Criteria

January 29, 2007

Last Verified

January 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK2512001

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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