CorneaNCT03010748
Multi-center Clinical Trial on Corneal Morphology Analysis in Chinese Population
An observational study of Cornea, run by Tianjin Eye Hospital at 1 site in China.
Trial summary
Based on the corneal morphometry instrumentation Oculus Pentacam, which is commonly used before and after clinical refractive surgery, we will collect the corneal morphological and biologic parameters of the population under refractive surgery screening in refractive surgery centers around the country, and construct… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cornea
- What is being tested?
- Scheimpflug tomography system (Pentacam) measurement
- Type of treatment
- Medical device
- How many people
- 50,000 participants
- Where
- 1 siteChina
- Study dates
- Nov 2015to Dec 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Chinese population of different nation from several provinces,including Jilin, Xi'an, Yunnan, Wuhan,etc.
Who may be able to join
- No less than 18 years old, in good health, have no active disease in the body and eye, have permanent resident status and have lived in the local area for at least 5 years (please mark the nation).
Who cannot join
- Eye diseases, glaucoma, ocular hypertension, glaucoma patients with normal pressure, fundus lesions, ptosis and other eyelid abnormalities.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Eye Hospital
Tianjin
Yan Wang, director, +86-02227305083, wangyan7143@vip.sina.com
About this study
Based on the corneal morphometry instrumentation Oculus Pentacam, which is commonly used before and after clinical refractive surgery, we will collect the corneal morphological and biologic parameters of the population under refractive surgery screening in refractive surgery centers around the country, and construct corneal morphology database in different living areas of Chinese people. Based on this, compared with the suspected keratoconus and keratoconus population, the screening criteria and reference standards accord with the characteristics of keratoconus of Chinese ethnic will be achieved.
Read the detailed description
The safety of refractive surgery has always been the focus of attention, keratoconus screening is the most important part for the preoperative examination of refractive surgery. Favorable tools and appropriate indicators are the premise of fast and accurate screening, and the corneal morphology from various regions of China have various characteristics, the use of uniform standards developed by foreign screening will always induce a lot of problems, for example, the differences of cornea morphological features between European and American ethnic and Chinese race, as well as the corneal morphometric indicators between various regions of China, will cause varying degrees of false-positive or false-negative screening results. Based on this, in order to further improve the safety of refractive surgery effectively and to obtain the effective and accurate screening of suspected keratoconus population, this study will be conducted to collect the corneal morphological characteristics database of Chinese people from all over the country, and to develop a database of Chinese ethnographic characteristics for screening keratoconus indicators and reference valuable to guide clinical screening and surgical design.
- Conditions
- Cornea
- Being tested
- Scheimpflug tomography system (Pentacam) measurement
- Keywords
- corneal morphology, Chinese population, corneal curvature, corneal thickness, higher order aberrations
- Medical subject headings
- Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scheimpflug tomography system (Pentacam) measurementDevice
The Scheimpflug tomography system (Pentacam,Oculus GmbH, Wetzlar, Germany) is a rotating Scheimpflug camera that measures 138,000 true elevation points to compute corneal topography. Patients were asked to blink twice and then look at the fixation device. Image acquisition was a 2-second scan of 50 rotational Scheimpflug images through the corneal sighting point, the point where the ray of light from the fovea to the fixation device crossed the cornea. All measurements were performed just after a blink to minimize the effect of tear film alteration on the data. Acceptable maps had at least 10.0 mm of corneal coverage with no extrapolated data in the central 9.0 mm zone.
| Study group | Role | What they receive |
|---|---|---|
| Chinese population | Chinese population of different nation from several provinces. Receives: Device: Scheimpflug tomography system (Pentacam) measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
corneal thickness
Measured: preoperative
Secondary outcomes (13)
corneal curvature measured by the Pentacam system
Measured: preoperative
coma aberration measured by the Pentacam system
Measured: preoperative
aspherical index measured by the Pentacam system
Measured: preoperative
spherical aberration measured by the Pentacam system
Measured: preoperative
corrected distance visual acuity
Measured: preoperative
uncorrected distance visual acuity
Measured: preoperative
refractive diopter
Measured: preoperative
corneal volume measured by the Pentacam system
Measured: preoperative
kapple angle measured by the Pentacam system
Measured: preoperative
introcular pressure
Measured: preoperative
corneal diameter measured by the Pentacam system
Measured: preoperative
anterior chamber depth measured by the Pentacam system
Measured: preoperative
anterior chamber angle measured by the Pentacam system
Measured: preoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study startNov 2015
- Primary completionAug 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for CorneaStudies 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 50,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Eye Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jilin University, Xi'an Jiaotong University, Second People's Hospital of Yunnan Province, Wuhan General Hospital of Guangzhou Military Command, Xinjiang Medical University, Gansu Provincial Hospital
- Responsible party
- Sponsor
- Investigators
- Yan Wang, director, Study director, Tianjin Eye HospitalXiaoyu li, Principal investigator, Second People's Hospital of Yunnan ProvinceYan Zhang, Principal investigator, Jilin UniversityJun Yang, Principal investigator, Gansu Provincial HospitalJing Li, Principal investigator, Xi'an Jiaotong UniversityXianglong Yi, Principal investigator, Xinjiang Medical UniversityZhengwei Shen, Principal investigator, Wuhan General Hospital of Guangzhou Military Command
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03010748
- Sponsor's protocol ID
- Tianjin EH-pentacam
- Status last verified
- May 2018
- First submitted
- 28 Dec 2016
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Silverman RH, Urs R, RoyChoudhury A, Archer TJ, Gobbe M, Reinstein DZ. Combined tomography and epithelial thickness mapping for diagnosis of keratoconus. Eur J Ophthalmol. 2017 Mar 10;27(2):129-134. doi: 10.5301/ejo.5000850. Epub 2016 Aug 8.
PubMed 27515569Chan TCY, Biswas S, Yu M, Jhanji V. Comparison of corneal measurements in keratoconus using swept-source optical coherence tomography and combined Placido-Scheimpflug imaging. Acta Ophthalmol. 2017 Sep;95(6):e486-e494. doi: 10.1111/aos.13298. Epub 2016 Nov 2.
PubMed 27805316Patrao LF, Canedo AL, Azevedo JL, Correa R, Ambrosio R Jr. Differentiation of mild keratoconus from corneal warpage according to topographic inferior steepening based on corneal tomography data. Arq Bras Oftalmol. 2016 Jul-Aug;79(4):264-7. doi: 10.5935/0004-2749.20160075.
PubMed 27626155Naderan M, Rajabi MT, Zarrinbakhsh P, Farjadnia M. Is keratoconus more severe in pediatric population? Int Ophthalmol. 2017 Oct;37(5):1169-1173. doi: 10.1007/s10792-016-0382-5. Epub 2016 Oct 25.
PubMed 27783185Ma J, Zhao L, Yang Y, Yun D, Yu-Wai-Man P, Zhu Y, Chen C, Li JO, Li M, Zhang Y, Cui T, Meng X, Zhang L, Zhang J, Song Y, Lei Y, Liu J, Huangfu X, Jiang L, Cai J, Wu H, Shang L, Wen D, Yi X, Zhang Y, Li X, Xiao J, He R, Yang Y, Yang J, Cheng GPM, Bai J, Zhong X, Guo H, Yan P, Wang Y, Lin H. Associations Between Regional Environment and Cornea-Related Morphology of the Eye in Young Adults: A Large-Scale Multicenter Cross-Sectional Study. Invest Ophthalmol Vis Sci. 2021 Feb 1;62(2):35. doi: 10.1167/iovs.62.2.35.
PubMed 33620373
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Clinical Trial on Corneal Morphology Analysis in Chinese Population
- ClinicalTrials.gov ID
- NCT03010748
- Acronym / sponsor ID
- Tianjin EH-pentacam
- Conditions
- Cornea
- Keywords
- corneal morphology, Chinese population, corneal curvature, corneal thickness, higher order aberrations
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- Tianjin Eye HospitalUniversity, hospital or other
- Collaborators
- Jilin University, Xi'an Jiaotong University, Second People's Hospital of Yunnan Province, Wuhan General Hospital of Guangzhou Military Command, Xinjiang Medical University, Gansu Provincial Hospital
- Study start
- Nov 2015
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 5 Jan 2017 (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.
Based on the corneal morphometry instrumentation Oculus Pentacam, which is commonly used before and after clinical refractive surgery, we will collect the corneal morphological and biologic parameters of the population under refractive surgery screening in refractive surgery centers around the country, and construct corneal morphology database in different living areas of Chinese people. Based on this, compared with the suspected keratoconus and keratoconus population, the screening criteria and reference standards accord with the characteristics of keratoconus of Chinese ethnic will be achieved.
Detailed description
The safety of refractive surgery has always been the focus of attention, keratoconus screening is the most important part for the preoperative examination of refractive surgery. Favorable tools and appropriate indicators are the premise of fast and accurate screening, and the corneal morphology from various regions of China have various characteristics, the use of uniform standards developed by foreign screening will always induce a lot of problems, for example, the differences of cornea morphological features between European and American ethnic and Chinese race, as well as the corneal morphometric indicators between various regions of China, will cause varying degrees of false-positive or false-negative screening results. Based on this, in order to further improve the safety of refractive surgery effectively and to obtain the effective and accurate screening of suspected keratoconus population, this study will be conducted to collect the corneal morphological characteristics database of Chinese people from all over the country, and to develop a database of Chinese ethnographic characteristics for screening keratoconus indicators and reference valuable to guide clinical screening and surgical design.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chinese population | – | Device: Scheimpflug tomography system (Pentacam) measurementChinese population of different nation from several provinces. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese population of different nation from several provinces,including Jilin, Xi'an, Yunnan, Wuhan,etc.
Key inclusion criteria (1 listed)
- No less than 18 years old, in good health, have no active disease in the body and eye, have permanent resident status and have lived in the local area for at least 5 years (please mark the nation).
Key exclusion criteria (1 listed)
- Eye diseases, glaucoma, ocular hypertension, glaucoma patients with normal pressure, fundus lesions, ptosis and other eyelid abnormalities.
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 |
|---|---|---|
| Scheimpflug tomography system (Pentacam) measurementThe Scheimpflug tomography system (Pentacam,Oculus GmbH, Wetzlar, Germany) is a rotating Scheimpflug camera that measures 138,000 true elevation points to compute corneal topography. Patients were asked to blink twice and then look at the fixation device. Image acquisition was a 2-second scan of 50 rotational Scheimpflug images through the corneal sighting point, the point where the ray of light from the fovea to the fixation device crossed the cornea. All measurements were performed just after a blink to minimize the effect of tear film alteration on the data. Acceptable maps had at least 10.0 mm of corneal coverage with no extrapolated data in the central 9.0 mm zone. | Device | Chinese population |
Primary outcome
corneal thickness
Time frame: preoperative
13 secondary outcomes
corneal curvature measured by the Pentacam system
Time frame: preoperative
coma aberration measured by the Pentacam system
Time frame: preoperative
aspherical index measured by the Pentacam system
Time frame: preoperative
spherical aberration measured by the Pentacam system
Time frame: preoperative
corrected distance visual acuity
Time frame: preoperative
uncorrected distance visual acuity
Time frame: preoperative
refractive diopter
Time frame: preoperative
corneal volume measured by the Pentacam system
Time frame: preoperative
kapple angle measured by the Pentacam system
Time frame: preoperative
introcular pressure
Time frame: preoperative
corneal diameter measured by the Pentacam system
Time frame: preoperative
anterior chamber depth measured by the Pentacam system
Time frame: preoperative
anterior chamber angle measured by the Pentacam system
Time frame: preoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
- Background: PubMed 27515569Silverman RH, Urs R, RoyChoudhury A, Archer TJ, Gobbe M, Reinstein DZ. Combined tomography and epithelial thickness mapping for diagnosis of keratoconus. Eur J Ophthalmol. 2017 Mar 10;27(2):129-134. doi: 10.5301/ejo.5000850. Epub 2016 Aug 8.
- Background: PubMed 27805316Chan TCY, Biswas S, Yu M, Jhanji V. Comparison of corneal measurements in keratoconus using swept-source optical coherence tomography and combined Placido-Scheimpflug imaging. Acta Ophthalmol. 2017 Sep;95(6):e486-e494. doi: 10.1111/aos.13298. Epub 2016 Nov 2.
- Background: PubMed 27626155Patrao LF, Canedo AL, Azevedo JL, Correa R, Ambrosio R Jr. Differentiation of mild keratoconus from corneal warpage according to topographic inferior steepening based on corneal tomography data. Arq Bras Oftalmol. 2016 Jul-Aug;79(4):264-7. doi: 10.5935/0004-2749.20160075.
- Background: PubMed 27783185Naderan M, Rajabi MT, Zarrinbakhsh P, Farjadnia M. Is keratoconus more severe in pediatric population? Int Ophthalmol. 2017 Oct;37(5):1169-1173. doi: 10.1007/s10792-016-0382-5. Epub 2016 Oct 25.
- Derived from this study: PubMed 33620373Ma J, Zhao L, Yang Y, Yun D, Yu-Wai-Man P, Zhu Y, Chen C, Li JO, Li M, Zhang Y, Cui T, Meng X, Zhang L, Zhang J, Song Y, Lei Y, Liu J, Huangfu X, Jiang L, Cai J, Wu H, Shang L, Wen D, Yi X, Zhang Y, Li X, Xiao J, He R, Yang Y, Yang J, Cheng GPM, Bai J, Zhong X, Guo H, Yan P, Wang Y, Lin H. Associations Between Regional Environment and Cornea-Related Morphology of the Eye in Young Adults: A Large-Scale Multicenter Cross-Sectional Study. Invest Ophthalmol Vis Sci. 2021 Feb 1;62(2):35. doi: 10.1167/iovs.62.2.35.
- Combined tomography and epithelial thickness mapping for diagnosis of keratoconus.Link provided by the sponsor.
- Comparison of corneal measurements in keratoconus using swept-source optical coherence tomography and combined Placido-Scheimpflug imagingLink provided by the sponsor.
- Differentiation of mild keratoconus from corneal warpage according to topographic inferior steepening based on corneal tomography dataLink provided by the sponsor.
- Is keratoconus more severe in pediatric population?Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Yan Wang, director study director
Tianjin Eye Hospital
Xiaoyu li principal investigator
Second People's Hospital of Yunnan Province
Yan Zhang principal investigator
Jilin University
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 Cornea, run by Tianjin Eye Hospital 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 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 4 May 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Wang, director (+86-02227305083, wangyan7143@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
corneal thickness (time frame: preoperative). 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 NCT03010748, which also lists 5 linked publications.
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 4 May 2018; AzTrials last refreshed its copy on 6 Nov 2026.