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

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ClinicalTrials.gov Identifier: NCT00717080
Recruitment Status : Completed
First Posted : July 16, 2008
Last Update Posted : January 25, 2012
Sponsor:
Information provided by (Responsible Party):
Aurolab

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

Condition or disease Intervention/treatment Phase
Retinitis Pigmentosa Cataract Procedure: IOL surgery Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Role of Capsular Tension Ring in Anterior Capsular Contraction in Retinitis Pigmentosa Patients
Study Start Date : July 2008
Actual Primary Completion Date : May 2010
Actual Study Completion Date : June 2010


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. The percentage of anterior capsular contraction [ Time Frame: 1 day, 30 days,90 days,180 days,270days ]

Secondary Outcome Measures :
  1. Visual acuity [ Time Frame: 1 day, 30 days,90 days,180 days,270days ]


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Ages Eligible for Study:   35 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Aurolab
ClinicalTrials.gov Identifier: NCT00717080     History of Changes
Other Study ID Numbers: 2PR1210826
First Posted: July 16, 2008    Key Record Dates
Last Update Posted: January 25, 2012
Last Verified: October 2009

Keywords provided by Aurolab:
Retinitis Pigmentosa
Cataract

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