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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00838422
Enrollment
100
Registered
2009-02-06
Start date
2008-06-30
Completion date
2009-06-30
Last updated
2009-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratitis

Brief 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).

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.

Interventions

None listed

Sponsors

Far Eastern Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Repeatability and reproducibility of corneal thickness measurement3 months

Secondary

MeasureTime frame
Comparing central corneal thickness measurement among FD-OCT, ORA, and USP3 months

Countries

Taiwan

Contacts

Primary ContactShu-Wen Lo, MD
swchang2007@ntu.edu.tw02-89667000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026