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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00658502
• Other study ID #: FEMH97006
• Status: Recruiting
• Phase: N/A
• First received: April 11, 2008
• Last updated: April 14, 2008
• Start date: March 2008
• Est. completion date: August 2009

Study information

• Verified date: March 2008
• Source: Far Eastern Memorial Hospital
• Contact: Shu-Wen Chang, MD
• Phone: 886-8966-7000
• Email: swchang[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 30 Years

Eligibility

Inclusion Criteria:

1. Normal ocular health other than myopia or anisometropia

2. In good general health with no history of prematurity or cardiac or significant respiratory diseases

3. No allergy to atropine, tropicamide, proparacaine, and benzalkonium chloride

4. No previous or current use of contact lenses, bifocals, progressive addition lenses

5. No amblyopia or manifest strabismus, including intermittent tropia

Exclusion Criteria:

1. presence of keratoconus or other corneal disease

2. previous eye drops usage except Atropine

3. major ocular surgery history (including refractive surgery, scleral buckle, glaucoma filtering, cornea transplant, cataract and vitreoretinal surgery)

4. presence of other ocular conditions such as glaucoma, uveitis, or other ocular inflammatory or vitreoretinal diseases.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anisometropia
• Myopia

Locations

Country	Name	City	State
Taiwan	Far Eastern Memorial Hospital	Pan-chiao	Taipei county

Sponsors (1)

Lead Sponsor	Collaborator
Far Eastern Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	axial length, corneal hysteresis		3 month	No
Secondary	Refractive error, visual acuity, , intraocular pressure, , and corneal thickness		3 month	No