NCT03010748

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 28, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 5, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

May 4, 2018

Status Verified

May 1, 2018

Enrollment Period

3.8 years

First QC Date

December 28, 2016

Last Update Submit

May 3, 2018

Conditions

Cornea

Keywords

corneal morphologyChinese populationcorneal curvaturecorneal thicknesshigher order aberrations

Outcome Measures

Primary Outcomes (1)

  • corneal thickness

    preoperative

Secondary Outcomes (13)

  • corneal curvature measured by the Pentacam system

    preoperative

  • coma aberration measured by the Pentacam system

    preoperative

  • aspherical index measured by the Pentacam system

    preoperative

  • spherical aberration measured by the Pentacam system

    preoperative

  • corrected distance visual acuity

    preoperative

  • +8 more secondary outcomes

Study Arms (1)

Chinese population

Chinese population of different nation from several provinces.

Device: Scheimpflug tomography system (Pentacam) measurement

Interventions

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.

Chinese population

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chinese population of different nation from several provinces,including Jilin, Xi'an, Yunnan, Wuhan,etc.

You may qualify if:

  • 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).

You may not qualify if:

  • Eye diseases, glaucoma, ocular hypertension, glaucoma patients with normal pressure, fundus lesions, ptosis and other eyelid abnormalities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Eye Hospital

Tianjin, China

RECRUITING

Related Publications (5)

  • 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.

    PMID: 27515569BACKGROUND

  • 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.

    PMID: 27805316BACKGROUND

  • 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.

    PMID: 27626155BACKGROUND

  • 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.

    PMID: 27783185BACKGROUND

  • 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.

    PMID: 33620373DERIVED

Related Links

MeSH Terms

Conditions

Corneal Diseases

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Yan Wang, director

    Tianjin Eye Hospital

    STUDY DIRECTOR

  • Xiaoyu li

    Second People's Hospital of Yunnan Province

    PRINCIPAL INVESTIGATOR

  • Yan Zhang

    Jilin University

    PRINCIPAL INVESTIGATOR

  • Jun Yang

    Gansu Provincial Hospital

    PRINCIPAL INVESTIGATOR

  • Jing Li

    Xi'an Jiaotong University

    PRINCIPAL INVESTIGATOR

  • Xianglong Yi

    Xinjiang Medical University

    PRINCIPAL INVESTIGATOR

  • Zhengwei Shen

    Wuhan General Hospital of Guangzhou Military Command

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Wang, director

CONTACT

+86-02227305083wangyan7143@vip.sina.com

Lin Zhang

CONTACT

+86-02227305083zhanglin_2015@126.com

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2016

First Posted

January 5, 2017

Study Start

November 1, 2015

Primary Completion

August 1, 2019

Study Completion

December 1, 2019

Last Updated

May 4, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)