Green Laser Photocoagulation Study in Proliferative Diabe... | NCT00355680

Studies
Green Laser Photocoagulation Study in Proliferative Diabetic Retinopathy

NCT00355680

Sponsor

Aurolab

Status

Completed

Last Update Posted

Feb 11, 2009Estimated

Enrollment

24Actual

Phase

Phase 3

Conditions

Diabetic Retinopathy

Interventions

Green Laser (Aurolas, Aurolab)
Green Laser (Iridex)

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

Feb 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

Dec 2005

Primary Completion Date

Jul 2006Actual

Completion Date

Jul 2006Actual

First Submitted Date

Jul 21, 2006

First Submission Date that Met QC Criteria

Jul 21, 2006

First Posted Date

Jul 24, 2006Estimated

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

Feb 10, 2009

Last Update Posted Date

Feb 11, 2009Estimated

Name	Class
Raja Ramanna Centre for Advanced Technology (RRCAT)	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

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

To Demonstrate that indigenous green laser produces similar treatment effect on the retina when compared with already available green laser.

Detailed Description

Proliferative Diabetic Retinopathy is ocular pathology in poor glycaemic controlled Diabetic patient Characterized by micro-vascular pathology with capillary closure in the retina leading to hypoxia of tissue there by formation of immature vessels to provide better oxygenation of retinal tissue.

In this randomized double blinded study a convenient sample size of 24 eyes assigned to compare indigenously developed green laser with already available green laser.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Aurolab Green Laser	Device: Green Laser (Aurolas, Aurolab)
2	Active Comparator	Available Green Laser	Device: Green Laser (Iridex)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Green Laser (Aurolas, Aurolab)	Device	Green laser developed by Aurolab	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pigmentation of burn		2 months, 4 months, 6 months post laser
Lateral spread of burn		2 months, 4 months, 6 months post laser
Regression of new vessels		2 months, 4 months, 6 months post laser

Secondary Outcomes

Measure	Description	Time Frame
Choroidal detachment		2 months, 4 months, 6 months post laser
Retinal detachment		2 months, 4 months, 6 months post laser
Tractional retinal detachment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients more than 18 years of age
Eyes with proliferative diabetic retinopathy requiring laser photocoagulation

Exclusion Criteria:

Eyes with media opacities not allowing proper fundus photography or adequate laser photocoagulation
Patients requiring more than two sessions of laser photocoagulation
Patients who had undergone previous laser photocoagulation
Patients who had undergone any previous vitreo-retinal surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chandra Mohan, MS	Arvind Eye Hospital, Madurai	Principal Investigator
Dhananjay Shukla, MS	Aravind Eye Hospital	Principal Investigator
Naresh Babu, MS, FNB	Aravind Eye Hospital	Principal Investigator

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D003930	Diabetic Retinopathy
D012164	Retinal Diseases

Ancestor Terms

ID	Term
D005128	Eye Diseases
D003925	Diabetic Angiopathies
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided