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Completed

NCT Number: NCT00717080

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

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

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Key information

Conditions

Retinitis Pigmentosa Cataract Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Lens Diseases Retinal Degeneration Retinal Diseases Retinal Dystrophies

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aravind Eye Hospital

Madurai, Tamil Nadu, 625 020, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IOL surgery

Procedure

IOL surgery using capsular tension ring (AURORING)

Other names: AURORING

Primary outcomes

  1. The percentage of anterior capsular contraction

    Time frame: 1 day, 30 days,90 days,180 days,270days

Secondary outcomes

  1. Visual acuity

    Time frame: 1 day, 30 days,90 days,180 days,270days

Sponsors and collaborators

Lead sponsor

Aurolab

Other

Registry information

Official study title

Role of Capsular Tension Ring in Anterior Capsular Contraction in Retinitis Pigmentosa Patients

Acronym: ACO

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jul 16, 2008
Registry last updated
Jan 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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