Changes in Electroretinogram and Contrast Sensitivity After PASCAL Treatment - Full Text View

Sponsored by:	Asociación para Evitar la Ceguera en México
Information provided by:	Asociación para Evitar la Ceguera en México
ClinicalTrials.gov Identifier:	NCT00563043

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Pattern Scan Laser System vs Regular Photocoagulation System: Changes in Electroretinograms and Contrast Sensitivity Post Treatment.

Resource links provided by NLM:

MedlinePlus related topics: Diabetic Eye Problems Nuclear Scans Retinal Disorders

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:

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, DF
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:

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.

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

Study placed in the following topic categories:

Diabetic Retinopathy
Eye Diseases
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases

Endocrinopathy
Diabetes Complications
Retinal Diseases
Diabetic Angiopathies

Additional relevant MeSH terms:

Diabetic Retinopathy
Eye Diseases
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases

Cardiovascular Diseases
Diabetes Complications
Retinal Diseases
Diabetic Angiopathies

ClinicalTrials.gov processed this record on September 10, 2009