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Changes in Electroretinogram and Contrast Sensitivity After PASCAL Treatment

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Asociación para Evitar la Ceguera en México.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Asociación para Evitar la Ceguera en México
ClinicalTrials.gov Identifier:
NCT00563043
First received: November 22, 2007
Last updated: December 5, 2007
Last verified: December 2007
History of Changes
  Purpose

Laser photocoagulation has become the treatment of choice in PDR. Laser photocoagulation has become the treatment of choice in PDR. The aim is to destroy a substantial portion of the peripheral retina in order to reduce the angiogenic stimulus (decrease the difference between oxygen demand and the administration). Their effectiveness is determined by the extent of destruction of the retina (2.4).


Condition Intervention Phase
Non Proliferative Diabetic Retinopathy
Proliferative Diabetic Retinopathy
 Procedure: PASCAL laser treatment
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pattern Scan Laser System vs Regular Photocoagulation System: Changes in Electroretinograms and Contrast Sensitivity Post Treatment.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Asociación para Evitar la Ceguera en México:

Primary Outcome Measures:
  • Changes in a wave amplitude [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • changes in b wave amplitude [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • changes in ERG implicit time [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 8
Study Start Date: October 2007
Estimated Study Completion Date: February 2008
Intervention Details:
    Procedure: PASCAL laser treatment
    Patterns Scan Laser treatment in patients with PDR.
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   25 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients older than 25 years, with a diagnosis of severe NPDR or PRD.
  • Good pupil mydriasis (minimum 5mm) With clear media
  • Patients without previous laser treatment or treatment with antiangiogenic drug.

Exclusion Criteria:

  • Patients who do not accept informed consent.
  • Patients with clinical macular Edema before treatment.
  • Significant corneal opacity.
  • Patients with other eye diseases that interfere with the studies required for the monitoring of patients.
  • History of refractive surgery, glaucoma or ocular hypertension, intraocular inflammation, choroiditis multifocal, retinal detachment, optic neuropathy (4).
  • Patients with tractional retinal detachment due to abundant fibrovascular
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00563043

Contacts
Contact: Raul Velez-Montoya, MD 525510841400 ext 1171 rvelezmx@yahoo.com
Contact: Hugo Quiroz-Mercado, MD 525510841400 ext 1172 retinamex@yahoo.com

Locations
Mexico
Asociaciòn para Evitar la Ceguera en Mèxico Recruiting
Mèxico, DF, Mexico, 04030
Contact: Yoko Burgoa, Lic     525510841400 ext 1171     retinamex@yahoo.com    
Sponsors and Collaborators
Asociación para Evitar la Ceguera en México
Investigators
Principal Investigator: Raul Velez-Montoya, MD Asociaciòn para Evitar la Ceguera en Mèxico
Principal Investigator: Hugo Quiroz-Mercado, MD Asociaciòn para Evitar la Ceguera en Mèxico
Principal Investigator: Virgilio Morales-Canton, MD Asociaciòn para Evitar la Ceguera en Mèxico
Principal Investigator: Juan Manuel Jimenez-Sierra, MD Asociaciòn para Evitar la Ceguera en Mèxico
  More Information

Publications:

Responsible Party: Asociacion para evitar la ceguera en mexico, apec
ClinicalTrials.gov Identifier: NCT00563043     History of Changes
Other Study ID Numbers: PASCAL002
Study First Received: November 22, 2007
Last Updated: December 5, 2007
Health Authority: Mexico: Ministry of Health

Keywords provided by Asociación para Evitar la Ceguera en México:
Pattern Scan Laser.
Photocoagulation.
Diabetic retinopathy treatment.
Laser treatment.
 Electroretinogram.
a wave.
b wave.
Implicit time.

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 22, 2013