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

• Conditions: Cornea

• Registration Number: NCT03010748
• Lead Sponsor: Tianjin Eye Hospital

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.

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 Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-12-28
• Study First Submitted QC: 2017-01-03
• Study First Posted: 2017-01-05
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-03
• Last Update Posted: 2018-05-04
• Primary Completion: 2019-08
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
corneal thickness	preoperative

Secondary Outcome Measures

Name	Time	Method
anterior chamber depth measured by the Pentacam system	preoperative
anterior chamber angle measured by the Pentacam system	preoperative
kapple angle measured by the Pentacam system	preoperative
corneal diameter 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
uncorrected distance visual acuity	preoperative
corneal volume measured by the Pentacam system	preoperative
refractive diopter	preoperative
introcular pressure	preoperative
corneal curvature measured by the Pentacam system	preoperative

Trial Locations

Locations (1)

Tianjin Eye Hospital; 🇨🇳 Tianjin, China