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Changes in Electroretinogram and Contrast Sensitivity After PASCAL Treatment

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ClinicalTrials.gov Identifier: NCT00563043
Recruitment Status : Unknown
Verified December 2007 by Asociación para Evitar la Ceguera en México.
Recruitment status was:  Recruiting
First Posted : November 26, 2007
Last Update Posted : December 7, 2007
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Non Proliferative Diabetic Retinopathy Proliferative Diabetic Retinopathy Procedure: PASCAL laser treatment Phase 4

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pattern Scan Laser System vs Regular Photocoagulation System: Changes in Electroretinograms and Contrast Sensitivity Post Treatment.
Study Start Date : October 2007
Estimated Study Completion Date : February 2008
Arms and Interventions

Intervention Details:
    Procedure: PASCAL laser treatment
    Patterns Scan Laser treatment in patients with PDR.

Outcome Measures

Primary Outcome Measures :
  1. Changes in a wave amplitude [ Time Frame: 12 weeks ]
  2. changes in b wave amplitude [ Time Frame: 12 weeks ]
  3. changes in ERG implicit time [ Time Frame: 12 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): 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
First Posted: November 26, 2007    Key Record Dates
Last Update Posted: December 7, 2007
Last Verified: December 2007

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:
Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases