Changes in Macular Thickness After Patterns Scan Laser

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 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:
NCT00563628
First received: November 22, 2007
Last updated: November 23, 2007
Last verified: November 2007
  Purpose

Laser photocoagulation has become the treatment of choice in PDR. Laser photocoagulation has become the treatment of choice in TMD. 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.
Device: Panretinal photocoagulation with PASCAL system
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 Macular Edema Post Treatment.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Retinal thickness after treatment [ Time Frame: 12 weeks ]

Estimated Enrollment: 8
Study Start Date: October 2007
Estimated Study Completion Date: February 2008
Intervention Details:
    Device: Panretinal photocoagulation with PASCAL system
    Use the PASCAL laser system to deliver a retina photocoagulation
    Other Name: Pattern Scan Laser system
  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 tissue. Or important fibrovascular tissue that fold or detach the retina.
  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: NCT00563628

Contacts
Contact: Raul Velez-Montoya, MD 525510841400 ext 1171 rvelezmx@yahoo.com
Contact: Yoko Burgoa, Lic 525510841400 ext 1172 retinamex@yahoo.com

Locations
Mexico
Asociaciòn para Evitar la Ceguera en Mèxico Recruiting
Mexico, 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 Ascoiaciòn para Evitar la Ceguera en Mexico
Principal Investigator: Hugo Quiroz-Mercado, MD Asociaciòn para Evitar la Ceguera
Principal Investigator: Virgilio Morales-Canton, MD Asociaciòn para Evitar la Ceguera
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00563628     History of Changes
Other Study ID Numbers: PASCAL001
Study First Received: November 22, 2007
Last Updated: November 23, 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

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

ClinicalTrials.gov processed this record on September 30, 2014