The Role of Capsular Tension Ring (CTR) in Anterior Capsular Contraction (ACO)

January 24, 2012 updated by: Aurolab

Role of Capsular Tension Ring in Anterior Capsular Contraction in Retinitis Pigmentosa Patients

This is a Randomized Controlled Trial to study the role of Capsular Tension Ring in patients with Retinitis Pigmentosa

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cataract is a common complication in retinitis Pigmentosa (RP) patient especially posterior sub capsular cataract. Continuous curvilinear capsulorhexis is the preferred method of capsulotomy in cataract surgery. Anterior capsular contraction (ACO) is a unique complication following cataract surgery. The rate of which is higher in RP patients due to the weak zonules and the increased rate of inflammation. CTR has been proven to reduce the rate of contraction.

Study population includes 40 eyes having RP with cataract. 20 eyes will receive CTR and the other 20 would not receive CTR. The percentage of anterior capsular contraction would be evaluated using EPCO software.

Study Type

Interventional

Enrollment (Actual)

40

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

  • India
    • Tamil Nadu
      • Madurai, Tamil Nadu, India, 625 020
        • Aravind Eye Hospital

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

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 35 to 65 years
  • Typical retinitis pigmentosa
  • Reside within a radius of 100kms from Madurai
  • Patients willing to come for follow up
  • Patients with nuclear sclerosis grade 2 or 3 or cortical cataract or pscc

Exclusion Criteria:

  • Diabetic patients
  • Traumatic cataract
  • Uveitis
  • Glaucoma
  • Pseudoexfoliation
  • Myotonic dystrophy
  • Corneal pathology
  • Pupil size <6mm
  • Intra op complications like zonular dialysis,pc rupture
  • Rhexis not covering iol optic

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
IOL surgery with Capsular Tension Ring
Procedure: IOL surgery
IOL surgery using capsular tension ring (AURORING)
Other Names:
  • AURORING
Procedure: IOL surgery
IOL surgery without CTR
Other Names:
  • Phacoemulsification
Placebo Comparator: Arm 2
IOL surgery without Capsular Tension Ring
Procedure: IOL surgery
IOL surgery using capsular tension ring (AURORING)
Other Names:
  • AURORING
Procedure: IOL surgery
IOL surgery without CTR
Other Names:
  • Phacoemulsification

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The percentage of anterior capsular contraction
Time Frame: 1 day, 30 days,90 days,180 days,270days
1 day, 30 days,90 days,180 days,270days

Secondary Outcome Measures

Outcome Measure
Time Frame
Visual acuity
Time Frame: 1 day, 30 days,90 days,180 days,270days
1 day, 30 days,90 days,180 days,270days

Collaborators and Investigators

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

Sponsor

Aurolab

Investigators

  • Principal Investigator: Haripriya Aravind, MS, Aravind Eye Hospital, Madurai

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, 2008

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

July 15, 2008

First Submitted That Met QC Criteria

July 15, 2008

First Posted (Estimate)

July 16, 2008

Study Record Updates

Last Update Posted (Estimate)

January 25, 2012

Last Update Submitted That Met QC Criteria

January 24, 2012

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2PR1210826

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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