Reliability of Pachymetry Measurement With FD-oCT, ORA, Confoscan 4 and Ultrasound
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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).
| Condition |
|---|
|
Keratitis |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Repeatability and Reproducibility of Pachymetric Mapping With Fourier Domain Optical Coherence Tomography, Ocular Response Analyzer, Confoscan 4 and Ultrasound |
- Repeatability and reproducibility of corneal thickness measurement [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Comparing central corneal thickness measurement among FD-OCT, ORA, and USP [ Time Frame: 3 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | June 2009 |
| Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| FD-OCT, ORA, USP |
Detailed 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.
Eligibility| Ages Eligible for Study: | 20 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Healthy volunteer who has no prior ocular disease history and prior intraocular surgical history
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.
Contacts and Locations| Contact: Shu-Wen Lo, MD | 02-89667000 ext 4271 | swchang2007@ntu.edu.tw |
| Taiwan | |
| Far Eastern Memorial Hospital | Recruiting |
| Pan-Chiao, Taipei County, Taiwan, 220 | |
| Principal Investigator: Shu-Wen Chang, MD | |
| Principal Investigator: | Shu-Wen Chang, MD | Far Eastern Memorial Hospital |
More Information
No publications provided
| Responsible Party: | Shu-Wen Chang, Far Eastern Memorial Hospital |
| ClinicalTrials.gov Identifier: | NCT00838422 History of Changes |
| Other Study ID Numbers: | FEMH97010 |
| Study First Received: | February 4, 2009 |
| Last Updated: | February 5, 2009 |
| Health Authority: | Taiwan: Institutional Review Board |
Additional relevant MeSH terms:
|
Keratitis Corneal Diseases Eye Diseases |
ClinicalTrials.gov processed this record on May 23, 2013