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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-06-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Retinitis Pigmentosa Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1

IOL surgery with Capsular Tension Ring

Group Type EXPERIMENTAL

IOL surgery

Intervention Type PROCEDURE

IOL surgery using capsular tension ring (AURORING)

Arm 2

IOL surgery without Capsular Tension Ring

Group Type PLACEBO_COMPARATOR

IOL surgery

Intervention Type PROCEDURE

IOL surgery without CTR

Interventions

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IOL surgery

IOL surgery using capsular tension ring (AURORING)

Intervention Type PROCEDURE

IOL surgery

IOL surgery without CTR

Intervention Type PROCEDURE

Other Intervention Names

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AURORING Phacoemulsification

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No