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

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

Study Overview

• Status: Unknown
• Conditions: Myopia; Anisometropia

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Taiwan
  • Taipei county
    • Pan-chiao, Taipei county, Taiwan, 220
      • Recruiting
      • Far Eastern Memorial Hospital
      • Contact: Shu-Wen Chang, MD; Phone Number: 2601 886-8966-2000; Email: swchang@ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

age under 25 year old with or without myopia

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
1
2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
axial length, corneal hysteresis	3 month

Secondary Outcome Measures

Outcome Measure	Time Frame
Refractive error, visual acuity, , intraocular pressure, , and corneal thickness	3 month

Collaborators and Investigators

• Sponsor: Far Eastern Memorial Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Anticipated): August 1, 2009
• Study Completion (Anticipated): August 1, 2009

Study Registration Dates

• First Submitted: April 11, 2008
• First Submitted That Met QC Criteria: April 14, 2008
• First Posted (Estimate): April 15, 2008

Study Record Updates

• Last Update Posted (Estimate): April 15, 2008
• Last Update Submitted That Met QC Criteria: April 14, 2008
• Last Verified: March 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Anisometropia
• Other Study ID Numbers: FEMH97006