Ocular Response Analyzer Assessment of Intraocular Pressure and Corneal Biomechanical Properties in Myopic and Anisometropic Patients Under Atropine Treatment - Full Text View

Ocular Response Analyzer Assessment of Intraocular Pressure and Corneal Biomechanical Properties in Myopic and Anisometropic Patients Under Atropine Treatment

This study is currently recruiting participants.
Verified by Far Eastern Memorial Hospital, March 2008

Sponsored by:	Far Eastern Memorial Hospital
Information provided by:	Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier:	NCT00658502

Purpose

Our study has three parts has three parts, and the main aim of the study is to find out if corneal hysteresis was associated with myopia or even a predictor of myopia poor control predictor:

Part 1 of our study: patients with anisomeropia whose spherical equivalent refraction as measured by cycloplegic autorefraction between the two eyes differ greater than 1.5 D.
Part 2 of our study: Minus spherical equivalent refraction as measured by cycloplegic autorefraction.
Part 3 of our study: patients with minus spherical equivalent refraction as measured by cycloplegic autorefraction who are under regular atropine for the treatment of myopia;patients who are prescribed with atropine treatment are in need of myopia control instead of for research interest

Condition

Myopia
Anisometropia

ChemIDplus related topics:

Atropine Atropine sulfate

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

Official Title:	Ocular Response Analyzer Assessment of Intraocular Pressure and Corneal Biomechanical Properties in Myopic and Anisometropic Patients Under Atropine Treatment

Further study details as provided by Far Eastern Memorial Hospital:

Primary Outcome Measures:

axial length, corneal hysteresis [ Time Frame: 3 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Refractive error, visual acuity, , intraocular pressure, , and corneal thickness [ Time Frame: 3 month ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	March 2008
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts

Eligibility

Ages Eligible for Study:	6 Years to 30 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

age under 25 year old with or without myopia

Criteria

Inclusion Criteria:

Normal ocular health other than myopia or anisometropia
In good general health with no history of prematurity or cardiac or significant respiratory diseases
No allergy to atropine, tropicamide, proparacaine, and benzalkonium chloride
No previous or current use of contact lenses, bifocals, progressive addition lenses
No amblyopia or manifest strabismus, including intermittent tropia

Exclusion Criteria:

presence of keratoconus or other corneal disease
previous eye drops usage except Atropine
major ocular surgery history (including refractive surgery, scleral buckle, glaucoma filtering, cornea transplant, cataract and vitreoretinal surgery)
presence of other ocular conditions such as glaucoma, uveitis, or other ocular inflammatory or vitreoretinal diseases.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00658502

Contacts


Contact: Shu-Wen Chang, MD	886-8966-7000 ext 2601	swchang@ntu.edu.tw

Locations


Taiwan, Taipei county
	Far Eastern Memorial Hospital	Recruiting
	Pan-chiao, Taipei county, Taiwan, 220
	Contact: Shu-Wen Chang, MD 886-8966-2000 ext 2601 swchang@ntu.edu.tw
	Principal Investigator: Shu-Wen Chang, MD

Sponsors and Collaborators

Far Eastern Memorial Hospital

More Information

Responsible Party:	Far Eastern Memorial Hospital ( Shu-Wen Chang/Far Eastern Memorial Hospital )
Study ID Numbers:	FEMH97006
First Received:	April 11, 2008
Last Updated:	April 14, 2008
ClinicalTrials.gov Identifier:	NCT00658502
Health Authority:	Taiwan: Institutional Review Board

Study placed in the following topic categories:

Eye Diseases

Myopia

Refractive Errors

Anisometropia

Atropine

ClinicalTrials.gov processed this record on October 17, 2008