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Panretinal Photocoagulation for Diabetic Retinopathy With PASCAL Laser

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Federal University of São Paulo.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01304225
First received: February 24, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Diabetic Retinopathy
 Procedure: Panretinal photocoagulation
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Panretinal Photocoagulation for Diabetic Retinopathy With PASCAL Laser - an Anatomic and Functional Evaluation of Different Treatment Strategies

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Incidence of severe visual loss after 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Severe visual loss is defined as visual acuity worse or equal to 5/200 in two consecutive visits (DRS/ETDRS primary outcome)


Secondary Outcome Measures:
  • Clinical involution of retinal new vessels [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Clinical involution of retinal new vessels will be evaluated with retinography and fluorescein angiography

  • Nerve fiber layer thickness [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Nerve fiber layer thickness will be evaluated with Spectral Domain OCT

  • Retinal sensitivity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Retinal sensitivity will be evaluated with Humphrey computerized perimetry and FDT (Frequency Doubling Technology)


Estimated Enrollment: 60
Study Start Date: September 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 100ms single-shot
Panretinal photocoagulation utilizing 100ms pulse duration, moderate intensity burns, in a single-shot fashion
 Procedure: Panretinal photocoagulation
Panretinal photocoagulation utilizing 100ms pulse duration, moderate intensity burns, in a single-shot fashion
Experimental: 20ms multiple-shot
Panretinal photocoagulation utilizing 20ms pulse duration, moderate intensity burns, in a multiple-shot fashion
 Procedure: Panretinal photocoagulation
Panretinal photocoagulation utilizing 20ms pulse duration, moderate intensity burns, in a multiple-shot fashion
Experimental: 20ms multiple-shot, barely visible
Panretinal photocoagulation utilizing 20ms pulse duration, barely visible intensity burns, in a multiple-shot fashion
 Procedure: Panretinal photocoagulation
Panretinal photocoagulation utilizing 20ms pulse duration, barely visible intensity burns, in a multiple-shot fashion

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • proliferative or severe nonproliferative diabetic retinopathy (type 1 or type 2)
  • best corrected visual acuity of 20/50 or better
  • capability to read and follow instructions
  • capability to sign the consignment term

Exclusion Criteria:

  • best corrected visual acuity worse than 20/50
  • significant macular edema responsible for visual acuity lower than 20/50
  • media opacities (includes vitreous hemorrhage in the visual axis, but not a reabsorbing inferior vitreous hemorrhage)
  • previous laser treatment (PRP, focal or macular grid)
  • glaucoma (confirmed or suspicious)
  • other diseases of the retina and optic nerve
  • previous ocular surgery in the last 6 months
  • impossibility to obtain good quality images of retinography, angiography or OCT
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01304225

Contacts
Contact: Renato M Passos, MD 55 11 50852043 renatompassos@yahoo.com.br

Locations
Brazil
Department of Ophthalmology, Federal University of São Paulo Recruiting
São Paulo, SP, Brazil, 04023062
Sponsors and Collaborators
Federal University of São Paulo
  More Information

Publications:

Responsible Party: Renato Magalhães Passos, Doctor at the Ophthalmology Department of UNIFESP
ClinicalTrials.gov Identifier: NCT01304225     History of Changes
Other Study ID Numbers: PASCAL-001
Study First Received: February 24, 2011
Last Updated: February 24, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:
diabetic retinopathy
photocoagulation
PASCAL laser

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 May 23, 2013