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

Aurolab

Status and phase: Completed; Phase 4

Conditions: Cataract; Retinitis Pigmentosa

Treatments: Procedure: IOL surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT00717080

2PR1210826

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 35 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Arm 1

Experimental group

Description:

IOL surgery with Capsular Tension Ring

Treatment:

Procedure: IOL surgery

Procedure: IOL surgery

Arm 2

Placebo Comparator group

Description:

IOL surgery without Capsular Tension Ring

Treatment:

Procedure: IOL surgery

Procedure: IOL surgery