Comparison of Cross-Cylinder Approach and Routine Method for Laser Correction of Astigmatism - Full Text View

Sponsored by:	Tabriz University
Information provided by:	Tabriz University
ClinicalTrials.gov Identifier:	NCT00663923

Purpose

The purpose of this study is to determine whether cross-cylinder approach is more effective than routine method in laser correction of astigmatism.

Condition	Intervention	Phase
Astigmatism	Procedure: photorefractive keratectomy (PRK)	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparison of Cross-Cylinder Approach and Routine Method for Laser Correction of Astigmatism: A Randomized Clinical Study

Further study details as provided by Tabriz University:

Primary Outcome Measures:

Improvement of visual acuity (snelen chart), refraction, aberrometry [ Time Frame: six months after surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

aberrometry for higher order aberrations, refraction for residual and regressed astigmatism, snelen chart for visual acuity test [ Time Frame: six months postop ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	November 2007
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Taking laser (PRK): by cross-cylinder approach	Procedure: photorefractive keratectomy (PRK) comparison of PRK by cross-cylinder approach in one eye and PRK by monotoric (routine) method in the other eye for laser correction of astigmatism
2: Active Comparator taking laser (PRK): by routine method	Procedure: photorefractive keratectomy (PRK) comparison of PRK by cross-cylinder approach in one eye and PRK by monotoric (routine) method in the other eye for laser correction of astigmatism

Detailed Description:

All patients with eligible criteria and candidate for correction of astigmatism by excimer laser,will be treated using photorefractive keratectomy (PRK) technique. The right or left eye of every patient would be allocated randomly to one of the study methods. In spite of recent advances in excimer laser machines and surgical techniques,correction of astigmatism is not more successful compared to myopia. In this study we will compare the results of two methods of laser correction of astigmatism regarding to visual acuity,residual and regressed error and aberrations.

Eligibility

Ages Eligible for Study:	20 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

>20 years of age
refractive stability for at least one year
regular and symmetric astigmatism of >1.5 diopters

Exclusion Criteria:

corneal thickness<480 micron
keratoconus or suspected keratoconus
active ocular disease and systemic collagen disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663923

Contacts

Contact: Mohammad R Sedghipour, MD

98-41-1330-6619

sedghipm@yahoo.com

Locations

Iran, Islamic Republic of, East Azarbaijan
Nikookari hospital	Recruiting
Tabriz, East Azarbaijan, Iran, Islamic Republic of, 5154645395
Contact: Mohammad R Sedghipour, MD 98-91-4115-9811 sedghipm@yahoo.com
Principal Investigator: Mohammad R Sedghipour, MD

Sponsors and Collaborators

Tabriz University

Investigators

Study Director:

Mohammad R Sedghipoor, MD

Ophthalmology Department, Tabriz University of medical Sciences

More Information

No publications provided

Responsible Party:	Tabriz University of medical sciences ( Dr.Javadzadeh )
Study ID Numbers:	86-43
Study First Received:	April 18, 2008
Last Updated:	April 21, 2008
ClinicalTrials.gov Identifier:	NCT00663923 History of Changes
Health Authority:	Iran: Ethics Committee

Keywords provided by Tabriz University:

Excimer Laser
photorefractive keratectomy
astigmatism

Study placed in the following topic categories:

Eye Diseases
Refractive Errors
Astigmatism

Additional relevant MeSH terms:

Eye Diseases
Refractive Errors
Astigmatism

ClinicalTrials.gov processed this record on September 10, 2009