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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aurolab
ClinicalTrials.gov Identifier:
NCT00717080
First received: July 15, 2008
Last updated: January 24, 2012
Last verified: October 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Retinitis Pigmentosa
Cataract
 Procedure: IOL surgery
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Role of Capsular Tension Ring in Anterior Capsular Contraction in Retinitis Pigmentosa Patients

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Aurolab:

Primary Outcome Measures:
  • The percentage of anterior capsular contraction [ Time Frame: 1 day, 30 days,90 days,180 days,270days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual acuity [ Time Frame: 1 day, 30 days,90 days,180 days,270days ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: July 2008
Study Completion Date: June 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
IOL surgery with Capsular Tension Ring
 Procedure: IOL surgery
IOL surgery using capsular tension ring (AURORING)
Other Name: AURORING
Placebo Comparator: Arm 2
IOL surgery without Capsular Tension Ring
 Procedure: IOL surgery
IOL surgery without CTR
Other Name: Phacoemulsification

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.

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00717080

Locations
India
Aravind Eye Hospital
Madurai, Tamil Nadu, India, 625 020
Sponsors and Collaborators
Aurolab
Investigators
Principal Investigator: Haripriya Aravind, MS Aravind Eye Hospital, Madurai
  More Information

No publications provided

Responsible Party: Aurolab
ClinicalTrials.gov Identifier: NCT00717080     History of Changes
Other Study ID Numbers: 2PR1210826
Study First Received: July 15, 2008
Last Updated: January 24, 2012
Health Authority: India: Ministry of Health

Keywords provided by Aurolab:
Retinitis Pigmentosa
Cataract

Additional relevant MeSH terms:
Retinitis
Retinitis Pigmentosa
Cataract
Retinal Diseases
Eye Diseases
 Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn
Lens Diseases

ClinicalTrials.gov processed this record on May 21, 2013