Comparison of Two Laser Therapy Methods for PDR (PDR)
Primary Purpose
Proiriftrative Diabetic Retinopathy
Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
conventional prp
targeted prp
Sponsored by
About this trial
This is an interventional treatment trial for Proiriftrative Diabetic Retinopathy
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
Sites / Locations
- Labbafinejad medical centerRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
conventional prp
targeted PRP
Arm Description
Outcomes
Primary Outcome Measures
no leakage in widefield fluorescin angiography
Secondary Outcome Measures
Full Information
NCT ID
NCT01232179
First Posted
November 1, 2010
Last Updated
November 1, 2010
Sponsor
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01232179
Brief Title
Comparison of Two Laser Therapy Methods for PDR
Acronym
PDR
Official Title
Comparison Between Result and Side Effects of Treatment of Prolifrative Diabetic Retinopaty by Conventional and Extended Targeted Pan Retinal Photocoagolation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
April 2011 (Anticipated)
Study Completion Date
May 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Shahid Beheshti University of Medical Sciences
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proiriftrative Diabetic Retinopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
ParticipantInvestigator
Allocation
Randomized
8. Arms, Groups, and Interventions
Arm Title
conventional prp
Arm Type
Active Comparator
Arm Title
targeted PRP
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
conventional prp
Intervention Description
pan retinal photocoagulation
Intervention Type
Procedure
Intervention Name(s)
targeted prp
Intervention Description
1200-1600 spot in far periphery retin, anterior equator
Primary Outcome Measure Information:
Title
no leakage in widefield fluorescin angiography
Time Frame
3 months after lasertraphy
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Labbafinejad medical center
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masoud Soheilian, proffesor
Phone
00982122585952
Email
masoud_soheilian@yahoo.com
First Name & Middle Initial & Last Name & Degree
masoud soheilian, proffesor
12. IPD Sharing Statement
Citations:
PubMed Identifier
28168567
Citation
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.
Results Reference
derived
Learn more about this trial
Comparison of Two Laser Therapy Methods for PDR
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