MyopiaNCT01587287
A Comprehensive Assessment of Anterior Corneal Power by Different Devices
An observational study of Myopia, run by Wenzhou Medical University at 1 site in China.
Trial summary
To comprehensively assess the precision and agreement of anterior corneal power measurements using 8 different devices. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Corneal power measurement
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- Apr 2011to Jul 2011
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The present study's definitions of reproducibility, repeatability and agreement were based on those adopted by the British Standards Institute and the International Organization for Standardization. Corneal curvature measurement provides crucial information for calculating intraocular lens power,screening and managing corneal refractive surgeries and corneal disease. Volunteers with healthy corneas will be measured by different instruments to detect their anterior corneal power.Only the right eye of each subject was selected.Measurements were repeated in the second session scheduled 1 to 2 weeks later, at almost the same time as the first session, by the same examiner using the same protocol.
Who may be able to join
- healthy cornea,
- best corrected distance visual acuity (BCVA) equal to or better than 20/25,
- willing and able to comply with scheduled visits and other study procedures.
Who cannot join
- History of refractive surgery or any keratoplasty procedure,
- use of contact lenses,
- history of corneal dystrophies or degenerative diseases,
- history of glaucoma or ocular hypertension,
- significant subjective dry eye symptoms, Schirmer I test results of less than 5.0 mm, tear film break-up time shorter than 5 seconds and corneal fluorescein staining positive.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comprehensive Assessment of the Precision and Agreement of Anterior Corneal Power Measurements Obtained Using Different Devices
To comprehensively assess the precision and agreement of anterior corneal power measurements using 8 different devices.
Read the detailed description
Volunteers with healthy corneas will be measured by different instruments to detect their anterior corneal power. Only the right eye of each subject was selected. Measurements were repeated in the second session scheduled 1 to 2 weeks later.
- Conditions
- Myopia
- Being tested
- Corneal power measurement
- Keywords
- Anterior corneal power, Placido topographer, Scheimpflug, Precision, Agreement
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corneal power measurementDevice
Also called Tomey RC-5000
All subjects will be underwent a full ophthalmic examination including vision, auto- and subjective refraction, slit-lamp examination, non-contact tonometry, corneal power measurements with the 8 devices and fundus examination.
| Study group | Role | What they receive |
|---|---|---|
| Corneal power measurement | All recruited volunteers in present study, that underwent corneal power measurement with 8 different instruments Receives: Device: Corneal power measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flat corneal power
The intrasession repeatability and intersession reproducibility of flat corneal curvature measurements by using the 8 commercially available instruments.
Measured: 2 weeks
Steep corneal power
The intrasession repeatability and intersession reproducibility of Steep corneal curvature measurements by using the 8 commercially available instruments.
Measured: 2 weeks
Secondary outcomes (2)
Vector power J0
The intrasession repeatability and intersession reproducibility of vector power J0 measurements by using the 8 commercially available instruments.
Measured: 2 weeks
Vector power J45
The intrasession repeatability and intersession reproducibility of vector power J45 measurements by using the 8 commercially available instruments.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2012 (estimated)
- Study startApr 2011
- Primary completionJun 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yifan Feng, Wenzhou Medical University
- Investigators
- Yifang Feng, MD, Principal investigator, Eye Hospital, Wenzhou Medical College, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01587287
- Sponsor's protocol ID
- YNKT201101
- Status last verified
- Jan 2011
- First submitted
- 23 Apr 2012
- Last updated
- 1 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wang Q, Savini G, Hoffer KJ, Xu Z, Feng Y, Wen D, Hua Y, Yang F, Pan C, Huang J. A comprehensive assessment of the precision and agreement of anterior corneal power measurements obtained using 8 different devices. PLoS One. 2012;7(9):e45607. doi: 10.1371/journal.pone.0045607. Epub 2012 Sep 25.
PubMed 23049823
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comprehensive Assessment of the Precision and Agreement of Anterior Corneal Power Measurements Obtained Using Different Devices
- ClinicalTrials.gov ID
- NCT01587287
- Acronym / sponsor ID
- YNKT201101
- Conditions
- Myopia
- Keywords
- Anterior corneal power, Placido topographer, Scheimpflug, Precision, Agreement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 30 Apr 2012 (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.
To comprehensively assess the precision and agreement of anterior corneal power measurements using 8 different devices.
Detailed description
Volunteers with healthy corneas will be measured by different instruments to detect their anterior corneal power. Only the right eye of each subject was selected. Measurements were repeated in the second session scheduled 1 to 2 weeks later.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Corneal power measurement | – | Device: Corneal power measurementAll recruited volunteers in present study, that underwent corneal power measurement with 8 different instruments |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The present study's definitions of reproducibility, repeatability and agreement were based on those adopted by the British Standards Institute and the International Organization for Standardization. Corneal curvature measurement provides crucial information for calculating intraocular lens power,screening and managing corneal refractive surgeries and corneal disease. Volunteers with healthy corneas will be measured by different instruments to detect their anterior corneal power.Only the right eye of each subject was selected.Measurements were repeated in the second session scheduled 1 to 2 weeks later, at almost the same time as the first session, by the same examiner using the same protocol.
Key inclusion criteria (3 listed)
- healthy cornea,
- best corrected distance visual acuity (BCVA) equal to or better than 20/25,
- willing and able to comply with scheduled visits and other study procedures.
Key exclusion criteria (5 listed)
- History of refractive surgery or any keratoplasty procedure,
- use of contact lenses,
- history of corneal dystrophies or degenerative diseases,
- history of glaucoma or ocular hypertension,
- significant subjective dry eye symptoms, Schirmer I test results of less than 5.0 mm, tear film break-up time shorter than 5 seconds and corneal fluorescein staining positive.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corneal power measurementAlso: Tomey RC-5000All subjects will be underwent a full ophthalmic examination including vision, auto- and subjective refraction, slit-lamp examination, non-contact tonometry, corneal power measurements with the 8 devices and fundus examination. | Device | Corneal power measurement |
Primary outcome
Flat corneal power
Time frame: 2 weeks
The intrasession repeatability and intersession reproducibility of flat corneal curvature measurements by using the 8 commercially available instruments.
Steep corneal power
Time frame: 2 weeks
The intrasession repeatability and intersession reproducibility of Steep corneal curvature measurements by using the 8 commercially available instruments.
2 secondary outcomes
Vector power J0
Time frame: 2 weeks
Vector power J45
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2012.
- Derived from this study: PubMed 23049823Wang Q, Savini G, Hoffer KJ, Xu Z, Feng Y, Wen D, Hua Y, Yang F, Pan C, Huang J. A comprehensive assessment of the precision and agreement of anterior corneal power measurements obtained using 8 different devices. PLoS One. 2012;7(9):e45607. doi: 10.1371/journal.pone.0045607. Epub 2012 Sep 25.
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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.
Yifang Feng, MD principal investigator
Eye Hospital, Wenzhou Medical College, China
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 Myopia, run by Wenzhou Medical University at 1 site in China.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 1 May 2012. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flat corneal power (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01587287, which also lists 1 linked publication.
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 1 May 2012.