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

Phase 4

Completed

• Conditions: Retinitis Pigmentosa; Cataract
• Interventions: Procedure: IOL surgery

• Registration Number: NCT00717080
• Lead Sponsor: Aurolab

Brief Summary

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

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 Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-15
• Study First Submitted QC: 2008-07-15
• Study First Posted: 2008-07-16
• Status Verified: 2009-10
• Primary Completion: 2010-05
• Study Completion: 2010-06
• Last Update Submitted: 2012-01-24
• Last Update Posted: 2012-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	IOL surgery	IOL surgery with Capsular Tension Ring
Arm 2	IOL surgery	IOL surgery without Capsular Tension Ring

Primary Outcome Measures

Name	Time	Method
The percentage of anterior capsular contraction	1 day, 30 days,90 days,180 days,270days

Secondary Outcome Measures

Name	Time	Method
Visual acuity	1 day, 30 days,90 days,180 days,270days

Trial Locations

Locations (1)

Aravind Eye Hospital; 🇮🇳 Madurai, Tamil Nadu, India