Comparison of Two Laser Therapy Methods for PDR

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Shahid Beheshti Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Shahid Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT01232179
First received: November 1, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted
  Purpose

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 Intervention Phase
Proiriftrative Diabetic Retinopathy
Procedure: conventional prp
Procedure: targeted prp
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Shahid Beheshti Medical University:

Primary Outcome Measures:
  • no leakage in widefield fluorescin angiography [ Time Frame: 3 months after lasertraphy ] [ Designated as safety issue: No ]

Study Start Date: October 2010
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Medical University
  More Information

No publications provided

Responsible Party: Masoud Soheilian, Ophthalmic Research center
ClinicalTrials.gov Identifier: NCT01232179     History of Changes
Other Study ID Numbers: 88100
Study First Received: November 1, 2010
Last Updated: November 1, 2010
Health Authority: Iran: Ethics commitee

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

ClinicalTrials.gov processed this record on July 24, 2014