Comparison of Two Laser Therapy Methods for PDR | NCT01232179

Studies
Comparison of Two Laser Therapy Methods for PDR

NCT01232179

Sponsor

Shahid Beheshti University of Medical Sciences

Status

Unknown status

Last Update Posted

Nov 2, 2010Estimated

Enrollment

Not provided

Phase

Phase 2

Conditions

Proiriftrative Diabetic Retinopathy

Interventions

conventional prp
targeted prp

Countries

Iran

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 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Apr 2011Estimated

Completion Date

May 2011Estimated

First Submitted Date

Nov 1, 2010

First Submission Date that Met QC Criteria

Nov 1, 2010

First Posted Date

Nov 2, 2010Estimated

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

Nov 1, 2010

Last Update Posted Date

Nov 2, 2010Estimated

Description Module

Brief Summary

Proliferative diabetic retinopathy (PDR) is treated with conventional pan retinal photocoagulation (PRP) which can improve the visual prognosis in this complication significantly. However , the treatment may also resulting adverse effects such as blurring of central vision, visual field constriction and disturbance in dark adaptation and contrast vision. Extended targeted retinal coagulation (TRP) to the ischemic areas may cause regression of the neovascularization while minimizing some of the risks and complication associated of treatment of PDR with these two methods.

Detailed Description

Not provided

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
conventional prp	Active Comparator		Procedure: conventional prp
targeted PRP	Active Comparator		Procedure: targeted prp

Interventions

Name	Type	Description	Arm Group Labels	Other Names
conventional prp	Procedure	pan retinal photocoagulation	conventional prp

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
no leakage in widefield fluorescin angiography		3 months after lasertraphy

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with PDR condidate for photocoagulation teraphy
Pupil with dilatasion≥6mm
without privious treatment with anti VEGF drugs 3months before study
without privious vitroretinal sugery
without privoius lasertraphy

Exclusion Criteria:

To have NVI cricteria with increase of inraocular pressure
to have cataract or vitrus leakage which prevent lasertraphy
pupil smaller that 6mm
traditional retinal detachment
privious treatment with anti VEGF drugs 3months before study
privious PRP
patient unable to get wide field FAG

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Labbafinejad medical center	Recruiting	Tehran	Tehran Province		Iran

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28168567	Derived	Nikkhah H, Ghazi H, Razzaghi MR, Karimi S, Ramezani A, Soheilian M. Extended targeted retinal photocoagulation versus conventional pan-retinal photocoagulation for proliferative diabetic retinopathy in a randomized clinical trial. Int Ophthalmol. 2018 Feb;38(1):313-321. doi: 10.1007/s10792-017-0469-7. Epub 2017 Feb 6.