NCT00717080

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 16, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

January 25, 2012

Status Verified

October 1, 2009

Enrollment Period

1.8 years

First QC Date

July 15, 2008

Last Update Submit

January 24, 2012

Conditions

Retinitis PigmentosaCataract

Keywords

Retinitis PigmentosaCataract

Outcome Measures

Primary Outcomes (1)

  • The percentage of anterior capsular contraction

    1 day, 30 days,90 days,180 days,270days

Secondary Outcomes (1)

  • Visual acuity

    1 day, 30 days,90 days,180 days,270days

Study Arms (2)

Arm 1

EXPERIMENTAL

IOL surgery with Capsular Tension Ring

Procedure: IOL surgery

Arm 2

PLACEBO COMPARATOR

IOL surgery without Capsular Tension Ring

Procedure: IOL surgery

Interventions

IOL surgeryPROCEDURE

IOL surgery using capsular tension ring (AURORING)

Also known as: AURORING
Arm 1

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aravind Eye Hospital

Madurai, Tamil Nadu, 625 020, India

Location

MeSH Terms

Conditions

Retinitis PigmentosaCataract

Interventions

Phacoemulsification

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesRetinal DystrophiesRetinal DegenerationRetinal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLens Diseases

Intervention Hierarchy (Ancestors)

Cataract ExtractionRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeUltrasonic Surgical Procedures

Study Officials

  • Haripriya Aravind, MS

    Aravind Eye Hospital, Madurai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2008

First Posted

July 16, 2008

Study Start

July 1, 2008

Primary Completion

May 1, 2010

Study Completion

June 1, 2010

Last Updated

January 25, 2012

Record last verified: 2009-10

Locations

IN(1)