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

Primary Purpose

Retinitis Pigmentosa, Cataract

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
IOL surgery
IOL surgery
Sponsored by
Aurolab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinitis Pigmentosa focused on measuring Retinitis Pigmentosa, Cataract

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Aravind Eye Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm Description

IOL surgery with Capsular Tension Ring

IOL surgery without Capsular Tension Ring

Outcomes

Primary Outcome Measures

The percentage of anterior capsular contraction

Secondary Outcome Measures

Visual acuity

Full Information

First Posted
July 15, 2008
Last Updated
January 24, 2012
Sponsor
Aurolab
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1. Study Identification

Unique Protocol Identification Number
NCT00717080
Brief Title
The Role of Capsular Tension Ring (CTR) in Anterior Capsular Contraction
Acronym
ACO
Official Title
Role of Capsular Tension Ring in Anterior Capsular Contraction in Retinitis Pigmentosa Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aurolab

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinitis Pigmentosa, Cataract
Keywords
Retinitis Pigmentosa, Cataract

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
IOL surgery with Capsular Tension Ring
Arm Title
Arm 2
Arm Type
Placebo Comparator
Arm Description
IOL surgery without Capsular Tension Ring
Intervention Type
Procedure
Intervention Name(s)
IOL surgery
Other Intervention Name(s)
AURORING
Intervention Description
IOL surgery using capsular tension ring (AURORING)
Intervention Type
Procedure
Intervention Name(s)
IOL surgery
Other Intervention Name(s)
Phacoemulsification
Intervention Description
IOL surgery without CTR
Primary Outcome Measure Information:
Title
The percentage of anterior capsular contraction
Time Frame
1 day, 30 days,90 days,180 days,270days
Secondary Outcome Measure Information:
Title
Visual acuity
Time Frame
1 day, 30 days,90 days,180 days,270days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haripriya Aravind, MS
Organizational Affiliation
Aravind Eye Hospital, Madurai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aravind Eye Hospital
City
Madurai
State/Province
Tamil Nadu
ZIP/Postal Code
625 020
Country
India

12. IPD Sharing Statement

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

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