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

History of Changes

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:

MedlinePlus related topics: Diabetic Eye Problems Edema Nuclear Scans Retinal Disorders

U.S. FDA Resources

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:

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

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:

Blumenkranz MS, Yellachich D, Andersen DE, Wiltberger MW, Mordaunt D, Marcellino GR, Palanker D. Semiautomated patterned scanning laser for retinal photocoagulation. Retina. 2006 Mar;26(3):370-6. No abstract available.

Perlman I, Gdal-On M, Miller B, Zonis S. Retinal function of the diabetic retina after argon laser photocoagulation assessed electroretinographically. Br J Ophthalmol. 1985 Apr;69(4):240-6.

Greenstein VC, Chen H, Hood DC, Holopigian K, Seiple W, Carr RE. Retinal function in diabetic macular edema after focal laser photocoagulation. Invest Ophthalmol Vis Sci. 2000 Oct;41(11):3655-64.

Varano M, Parisi V, Tedeschi M, Sciamanna M, Gallinaro G, Capaldo N, Catalano S, Pascarella A. Macular function after PDT in myopic maculopathy: psychophysical and electrophysiological evaluation. Invest Ophthalmol Vis Sci. 2005 Apr;46(4):1453-62.

Liang JC, Fishman GA, Huamonte FU, Anderson RJ. Comparative electroretinograms in argon laser and xenon arc panretinal photocoagulation. Br J Ophthalmol. 1983 Aug;67(8):520-5.

Rema M, Sujatha P, Pradeepa R. Visual outcomes of pan-retinal photocoagulation in diabetic retinopathy at one-year follow-up and associated risk factors. Indian J Ophthalmol. 2005 Jun;53(2):93-9.

Nonaka A, Kiryu J, Tsujikawa A, Yamashiro K, Nishijima K, Kamizuru H, Ieki Y, Miyamoto K, Nishiwaki H, Honda Y, Ogura Y. Inflammatory response after scatter laser photocoagulation in nonphotocoagulated retina. Invest Ophthalmol Vis Sci. 2002 Apr;43(4):1204-9.

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:

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

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