KeratitisNCT00838422
Reliability of Pachymetry Measurement With FD-oCT, ORA, Confoscan 4 and Ultrasound
An observational study of Keratitis, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Keratitis
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2008to Jun 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteer who has no prior ocular disease history and prior intraocular surgical history
Who may be able to join
- Healthy Volunteers
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Far Eastern Memorial Hospital
Banqiao District, Taipei, 220
Shu-Wen Chang, MD
About this study
Official title: 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).
Read the 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.
- Conditions
- Keratitis
- Medical subject headings
- Keratitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| FD-OCT, ORA, USP | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repeatability and reproducibility of corneal thickness measurement
Measured: 3 months
Secondary outcomes (1)
Comparing central corneal thickness measurement among FD-OCT, ORA, and USP
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2009 (estimated)
- Study startJun 2008
- Primary completionJan 2009 (estimated)
- Study completionJun 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Shu-Wen Chang, MD, Principal investigator, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00838422
- Sponsor's protocol ID
- FEMH97010
- Status last verified
- Feb 2009
- First submitted
- 4 Feb 2009
- Last updated
- 6 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeatability and Reproducibility of Pachymetric Mapping With Fourier Domain Optical Coherence Tomography, Ocular Response Analyzer, Confoscan 4 and Ultrasound
- ClinicalTrials.gov ID
- NCT00838422
- Acronym / sponsor ID
- FEMH97010
- Conditions
- Keratitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Jan 2009 (estimated)
- Study completion
- Jun 2009 (estimated)
- First posted
- 6 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FD-OCT, ORA, USP | – | – |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteer who has no prior ocular disease history and prior intraocular surgical history
Key inclusion criteria (1 listed)
- Healthy Volunteers
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Repeatability and reproducibility of corneal thickness measurement
Time frame: 3 months
1 secondary outcome
Comparing central corneal thickness measurement among FD-OCT, ORA, and USP
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shu-Wen Chang, MD principal investigator
Far Eastern Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Keratitis, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shu-Wen Lo, MD (02-89667000 ext. 4271, swchang2007@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Repeatability and reproducibility of corneal thickness measurement (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2009.