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

Cataract Clinical Trial

— ACO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00717080
• Other study ID #: 2PR1210826
• Status: Completed
• Phase: Phase 4
• First received: July 15, 2008
• Last updated: January 24, 2012
• Start date: July 2008
• Est. completion date: June 2010

Study information

• Verified date: October 2009
• Source: Aurolab
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Retinitis
• Retinitis Pigmentosa

Intervention

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

Locations

Country	Name	City	State
India	Aravind Eye Hospital	Madurai	Tamil Nadu

Sponsors (1)

Lead Sponsor	Collaborator
Aurolab

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of anterior capsular contraction		1 day, 30 days,90 days,180 days,270days	No
Secondary	Visual acuity		1 day, 30 days,90 days,180 days,270days	No