Role of Capsular Tension Ring in Anterior Capsular Contraction in Retinitis Pigmentosa Patients
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Aurolab
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- The percentage of anterior capsular contraction
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 35 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Pseudoexfoliation
- •Myotonic dystrophy
- •Corneal pathology
- •Pupil size <6mm
- •Intra op complications like zonular dialysis,pc rupture
- •Rhexis not covering iol optic
Outcomes
Primary Outcomes
The percentage of anterior capsular contraction
Time Frame: 1 day, 30 days,90 days,180 days,270days
Secondary Outcomes
- Visual acuity(1 day, 30 days,90 days,180 days,270days)