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

Overview

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

Full Title of Study: “Role of Capsular Tension Ring in Anterior Capsular Contraction in Retinitis Pigmentosa Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: May 2010

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.

Interventions

  • Procedure: IOL surgery
    • IOL surgery using capsular tension ring (AURORING)
  • Procedure: IOL surgery
    • IOL surgery without CTR

Arms, Groups and Cohorts

  • Experimental: Arm 1
    • IOL surgery with Capsular Tension Ring
  • Placebo Comparator: Arm 2
    • IOL surgery without Capsular Tension Ring

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 35 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Aurolab
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Haripriya Aravind, MS, Principal Investigator, Aravind Eye Hospital, Madurai

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