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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00838422
Other study ID # FEMH97010
Secondary ID
Status Recruiting
Phase N/A
First received February 4, 2009
Last updated February 5, 2009
Start date June 2008
Est. completion date June 2009

Study information

Verified date February 2009
Source Far Eastern Memorial Hospital
Contact Shu-Wen Lo, MD
Phone 02-89667000
Email swchang2007@ntu.edu.tw
Is FDA regulated No
Health authority Taiwan: Institutional Review Board
Study type Observational

Clinical Trial Summary

The purpose of this study is to assess the repeatability, reproducibility, and agreement of central corneal thickness measured by Fourier Domain Optical Coherence tomography (FD-OCT, OptoVue, USA) with anterior corneal module, 20MHz ultrasound pachymetry equipped with Ocular response analyzer (ORA, Reichert Ophthalmic Instruments, USA) and 10MHz Ultrasound Pachymetry (USP).


Description:

Corneal thickness measurements are clinically important. Variation in corneal thickness affects the accuracy of applanation tonometry. A meta-analysis by Doughty and Zaman showed that a 10% change in central corneal thickness may result in an approximately 3.4-mmHg change in intraocular pressure.1 Accuracy of corneal thickness measurement is also important in considering eligibility for refractive surgery, and the amount of correction that can safely be performed. Underestimation of corneal thickness may lead to eligible patients being excluded for primary or enhancement refractive procedures. Overestimation may lead to over-ablation and inadvertent thinning of the stroma, thereby increasing the risk of iatrogenic keratectasia. Hence, studies assessing corneal thickness measurements by various instruments are of high clinical relevance.2-9 Fourier domain optical coherence tomography (FD-OCT, OptoVue, U.S.A), Confoscan 4 (CS-4, Nidek, USA) and ocular response analyzer (ORA, Reichert, USA) are non-invasive medical devices that have recently received FDA approval for measurement of the cornea thickness. However, the repeatability and reproducibility of these instruments remains unproven in the clinical settings. To our knowledge, this is the first study to describe agreement, repeatability and reproducibility in corneal pachymetric mapping between FD-OCT, ORA, CS-4 and conventional ultrasound (US), which has been the current reference corneal pachymetric mapping system for the majority of refractive surgeons.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date June 2009
Est. primary completion date January 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 70 Years
Eligibility Inclusion Criteria:

- Healthy Volunteers

Exclusion Criteria:

- Patients who had history of prior ocular surgery, ocular abnormalities other than cataract or refractive error or were unable to cooperate in the examination were excluded.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


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 Repeatability and reproducibility of corneal thickness measurement 3 months No
Secondary Comparing central corneal thickness measurement among FD-OCT, ORA, and USP 3 months No
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