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Reliability of Pachymetry Measurement With FD-oCT, ORA, Confoscan 4 and Ultrasound

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Far Eastern Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00838422
First received: February 4, 2009
Last updated: February 5, 2009
Last verified: February 2009

February 4, 2009
February 5, 2009
June 2008
January 2009   (final data collection date for primary outcome measure)
Repeatability and reproducibility of corneal thickness measurement [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00838422 on ClinicalTrials.gov Archive Site
Comparing central corneal thickness measurement among FD-OCT, ORA, and USP [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Reliability of Pachymetry Measurement With FD-oCT, ORA, Confoscan 4 and Ultrasound
Repeatability and Reproducibility of Pachymetric Mapping With Fourier Domain Optical Coherence Tomography, Ocular Response Analyzer, Confoscan 4 and Ultrasound

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).

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Healthy volunteer who has no prior ocular disease history and prior intraocular surgical history

Keratitis
Not Provided
FD-OCT, ORA, USP
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
June 2009
January 2009   (final data collection date for primary outcome measure)

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.
Both
20 Years to 70 Years
Yes
Contact: Shu-Wen Lo, MD 02-89667000 ext 4271 swchang2007@ntu.edu.tw
Taiwan
 
NCT00838422
FEMH97010
Yes
Shu-Wen Chang, Far Eastern Memorial Hospital
Far Eastern Memorial Hospital
Not Provided
Principal Investigator: Shu-Wen Chang, MD Far Eastern Memorial Hospital
Far Eastern Memorial Hospital
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP