Clinical Trial: Panretinal Photocoagulation for Diabetic Retinopathy With PASCAL Laser

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Panretinal Photocoagulation for Diabetic Retinopathy With PASCAL Laser - an Anatomic and Functional Evaluation of Different Treatment Strategies

Brief Summary: This study will investigate the clinical efficacy and safety of the PASCAL laser (PAttern SCAn Laser) for diabetic retinopathy. Patients with proliferative or severe nonproliferative retinopathy will be treated with panretinal photocoagulation utilizing different treatment strategies. The investigators believe that using "lower" laser parameters, the clinical response may be equivalent with less adverse effects.

Detailed Summary:
Sponsor: Federal University of São Paulo

Current Primary Outcome: Incidence of severe visual loss after 1 year [ Time Frame: 1 year ]

Severe visual loss is defined as visual acuity worse or equal to 5/200 in two consecutive visits (DRS/ETDRS primary outcome)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Clinical involution of retinal new vessels [ Time Frame: 1 year ]
    Clinical involution of retinal new vessels will be evaluated with retinography and fluorescein angiography
  • Nerve fiber layer thickness [ Time Frame: 1 year ]
    Nerve fiber layer thickness will be evaluated with Spectral Domain OCT
  • Retinal sensitivity [ Time Frame: 1 year ]
    Retinal sensitivity will be evaluated with Humphrey computerized perimetry and FDT (Frequency Doubling Technology)


Original Secondary Outcome: Same as current

Information By: Federal University of São Paulo

Dates:
Date Received: February 24, 2011
Date Started: September 2010
Date Completion: March 2013
Last Updated: February 24, 2011
Last Verified: February 2011