The Role of Capsular Tension Ring (CTR) in Anterior Capsu... | NCT00717080

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

NCT00717080

Sponsor

Aurolab

Status

Completed

Last Update Posted

Jan 25, 2012Estimated

Enrollment

40Actual

Phase

Phase 4

Conditions

Retinitis Pigmentosa
Cataract

Interventions

IOL surgery
IOL surgery

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

May 2010Actual

Completion Date

Jun 2010Actual

First Submitted Date

Jul 15, 2008

First Submission Date that Met QC Criteria

Jul 15, 2008

First Posted Date

Jul 16, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 24, 2012

Last Update Posted Date

Jan 25, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
IOL surgery	Procedure	IOL surgery using capsular tension ring (AURORING)	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The percentage of anterior capsular contraction		1 day, 30 days,90 days,180 days,270days

Secondary Outcomes

Measure	Description	Time Frame
Visual acuity		1 day, 30 days,90 days,180 days,270days

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Haripriya Aravind, MS	Aravind Eye Hospital, Madurai	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aravind Eye Hospital		Madurai	Tamil Nadu	625 020	India

Condition Browse Module

MeSH Terms

ID	Term
D012174	Retinitis Pigmentosa
D002386	Cataract

Ancestor Terms

ID	Term
D015785	Eye Diseases, Hereditary
D005128	Eye Diseases
D058499	Retinal Dystrophies
D012162	Retinal Degeneration

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D018918	Phacoemulsification

Ancestor Terms

ID	Term
D002387	Cataract Extraction
D054140	Refractive Surgical Procedures
D013508	Ophthalmologic Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided