Multi-center Clinical Trial on Corneal Morphology Analysis in Chinese Population
NCT ID: NCT03010748
Last Updated: 2018-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
50000 participants
OBSERVATIONAL
2015-11-30
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CROSSOVER
CROSS_SECTIONAL
Study Groups
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Chinese population
Chinese population of different nation from several provinces.
Scheimpflug tomography system (Pentacam) measurement
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.
Interventions
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Scheimpflug tomography system (Pentacam) measurement
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Jilin University
OTHER
Xi'an Jiaotong University
OTHER
Second People's Hospital of Yunnan Province
OTHER
Wuhan General Hospital of Guangzhou Military Command
OTHER
Xinjiang Medical University
OTHER
Gansu Provincial Hospital
OTHER
Tianjin Eye Hospital
OTHER
Responsible Party
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Principal Investigators
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Yan Wang, director
Role: STUDY_DIRECTOR
Tianjin Eye Hospital
Xiaoyu li
Role: PRINCIPAL_INVESTIGATOR
Second People's Hospital of Yunnan Province
Yan Zhang
Role: PRINCIPAL_INVESTIGATOR
Jilin University
Jun Yang
Role: PRINCIPAL_INVESTIGATOR
Gansu Provincial Hospital
Jing Li
Role: PRINCIPAL_INVESTIGATOR
Xi'an Jiaotong University
Xianglong Yi
Role: PRINCIPAL_INVESTIGATOR
Xinjiang Medical University
Zhengwei Shen
Role: PRINCIPAL_INVESTIGATOR
Wuhan General Hospital of Guangzhou Military Command
Locations
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Tianjin Eye Hospital
Tianjin, , China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Chan 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.
Patrao 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.
Naderan 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.
Ma 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.
Related Links
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Combined tomography and epithelial thickness mapping for diagnosis of keratoconus.
Differentiation of mild keratoconus from corneal warpage according to topographic inferior steepening based on corneal tomography data
Is keratoconus more severe in pediatric population?
Other Identifiers
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Tianjin EH-pentacam
Identifier Type: -
Identifier Source: org_study_id
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