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
  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

Resource links provided by NLM:


Further study details as provided by Far Eastern Memorial Hospital:

Primary Outcome Measures:
  • Repeatability and reproducibility of corneal thickness measurement [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Study Population

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00838422

Contacts
Contact: Shu-Wen Lo, MD 02-89667000 ext 4271 swchang2007@ntu.edu.tw

Locations
Taiwan
Far Eastern Memorial Hospital Recruiting
Pan-Chiao, Taipei County, Taiwan, 220
Principal Investigator: Shu-Wen Chang, MD         
Sponsors and Collaborators
Far Eastern Memorial Hospital
Investigators
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

ClinicalTrials.gov processed this record on September 22, 2014