Posterior Capsule Opacification (PCO) With AcrySof Single-Piece IOL

March 3, 2009 updated by: Iladevi Cataract and IOL Research Center

Prospective Evaluation of Posterior Capsule Opacification in Myopic Eyes 4 Years After AcrySof Single-Piece IOL Implantation

The purpose of this study what to evaluate if axial myopia might influence the development of PCO.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We sought to prospectively compare PCO in eyes with myopia in relation to axial length with PCO in eyes with normal axial length, to decipher the role of axial myopia in PCO 4 years after surgery for senile cataract.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

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

  • India
    • gUJARAT
      • Ahmedabad, gUJARAT, India, 52
        • Raghudeep Eye Clinic

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

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • local residency and presence of a cataract in an otherwise normal eye.
  • Patients older than 50 years
  • a dilated pupil after mydriasis
  • Patients with retinochoroidal atrophy, retinal laser prophylaxis,
  • hypertension

Exclusion Criteria:

  • nondilating pupil after maximal dilation;
  • pseudoexfoliation; mature, traumatic, black, or complicated cataracts;
  • previous intraocular surgery;
  • previous surgery for glaucoma;
  • uveitis
  • diabetes mellitus
  • Patients who did not give consent preoperatively

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1. MYOPIA
axial length > 26.00 mm
Procedure: Phaco
AcrySof Single-Piece IOL
Other Names:
  • emmetropic eyes
  • normal axial length
Active Comparator: 2. Emmetropia
emmetropic eyes- eyes with an axial length of 21.00 to 23.99 mm
Procedure: Phaco
AcrySof Single-Piece IOL
Other Names:
  • emmetropic eyes
  • normal axial length

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the percentage area of PCO with posterior capsule opacity (POCO) software
Time Frame: 4 years
4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
the presence of PCO within the central 3-mm zone were noted
Time Frame: 4 years
4 years

Collaborators and Investigators

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

Sponsor

Iladevi Cataract and IOL Research Center

Investigators

  • Principal Investigator: ALPESH SHAH, MS, Iladevi Cataract and IOL Research 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

July 1, 2003

Primary Completion (Actual)

September 1, 2004

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

March 3, 2009

First Submitted That Met QC Criteria

March 3, 2009

First Posted (Estimate)

March 4, 2009

Study Record Updates

Last Update Posted (Estimate)

March 4, 2009

Last Update Submitted That Met QC Criteria

March 3, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-009

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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