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Comparison of Two Laser Therapy Methods for PDR (PDR)

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ClinicalTrials.gov Identifier: NCT01232179
Recruitment Status : Unknown
Verified October 2010 by Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : November 2, 2010
Last Update Posted : November 2, 2010
Sponsor:
Information provided by:
Shahid Beheshti University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Proiriftrative Diabetic Retinopathy Procedure: conventional prp Procedure: targeted prp Phase 2

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Comparison Between Result and Side Effects of Treatment of Prolifrative Diabetic Retinopaty by Conventional and Extended Targeted Pan Retinal Photocoagolation
Study Start Date : October 2010
Estimated Primary Completion Date : April 2011
Estimated Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: conventional prp Procedure: conventional prp
pan retinal photocoagulation
Active Comparator: targeted PRP Procedure: targeted prp
1200-1600 spot in far periphery retin, anterior equator



Primary Outcome Measures :
  1. no leakage in widefield fluorescin angiography [ Time Frame: 3 months after lasertraphy ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01232179


Locations
Iran, Islamic Republic of
Labbafinejad medical center Recruiting
Tehran, Iran, Islamic Republic of
Contact: Masoud Soheilian, proffesor    00982122585952    masoud_soheilian@yahoo.com   
Principal Investigator: masoud soheilian, proffesor         
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Masoud Soheilian, Ophthalmic Research center
ClinicalTrials.gov Identifier: NCT01232179     History of Changes
Other Study ID Numbers: 88100
First Posted: November 2, 2010    Key Record Dates
Last Update Posted: November 2, 2010
Last Verified: October 2010

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases