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

NCT03010748 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50000

Last updated 2018-05-04

No results posted yet for this study

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.

Conditions

  • Cornea

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Jilin University

    collaborator OTHER
  • Xi'an Jiaotong University

    collaborator OTHER
  • Second People's Hospital of Yunnan Province

    collaborator OTHER
  • Wuhan General Hospital of Guangzhou Military Command

    collaborator OTHER
  • Xinjiang Medical University

    collaborator OTHER
  • Gansu Provincial Hospital

    collaborator OTHER
  • Tianjin Eye Hospital

    lead OTHER

Principal Investigators

  • Yan Wang, director · Tianjin Eye Hospital

  • Xiaoyu li · Second People's Hospital of Yunnan Province

  • Yan Zhang · Jilin University

  • Jun Yang · Gansu Provincial Hospital

  • Jing Li · Xi'an Jiaotong University

  • Xianglong Yi · Xinjiang Medical University

  • Zhengwei Shen · Wuhan General Hospital of Guangzhou Military Command

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2019-08-31
Completion
2019-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03010748 on ClinicalTrials.gov