Multi-center Clinical Trial on Corneal Morphology Analysis in Chinese Population

NCT ID: NCT03010748

Last Updated: 2018-05-04

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

50000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2019-12-31

Brief Summary

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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

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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

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Cornea

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Chinese population

Chinese population of different nation from several provinces.

Scheimpflug tomography system (Pentacam) measurement

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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).

Exclusion Criteria

* Eye diseases, glaucoma, ocular hypertension, glaucoma patients with normal pressure, fundus lesions, ptosis and other eyelid abnormalities.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jilin University

OTHER

Sponsor Role collaborator

Xi'an Jiaotong University

OTHER

Sponsor Role collaborator

Second People's Hospital of Yunnan Province

OTHER

Sponsor Role collaborator

Wuhan General Hospital of Guangzhou Military Command

OTHER

Sponsor Role collaborator

Xinjiang Medical University

OTHER

Sponsor Role collaborator

Gansu Provincial Hospital

OTHER

Sponsor Role collaborator

Tianjin Eye Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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China

Central Contacts

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Yan Wang, director

Role: CONTACT

+86-02227305083

Lin Zhang

Role: CONTACT

+86-02227305083

Facility Contacts

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Yan Wang, director

Role: primary

+86-02227305083

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.

Reference Type BACKGROUND
PMID: 27515569 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27805316 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27626155 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27783185 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33620373 (View on PubMed)

Related Links

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http://www.eur-j-ophthalmol.com/article/640efc2c-7e6d-47ad-b8ca-19ef814a8101

Combined tomography and epithelial thickness mapping for diagnosis of keratoconus.

http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0004-27492016000400264&lng=en&nrm=iso&tlng=en

Differentiation of mild keratoconus from corneal warpage according to topographic inferior steepening based on corneal tomography data

http://link.springer.com/article/10.1007%2Fs10792-016-0382-5

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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