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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03010748
Enrollment
50000
Registered
2017-01-05
Start date
2015-11-30
Completion date
2019-12-31
Last updated
2018-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cornea

Keywords

corneal morphology, Chinese population, corneal curvature, corneal thickness, higher order aberrations

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.

Interventions

DEVICEScheimpflug 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

Jilin University
CollaboratorOTHER
Xi'an Jiaotong University
CollaboratorOTHER
Second People's Hospital of Yunnan Province
CollaboratorOTHER
Wuhan General Hospital of Guangzhou Military Command
CollaboratorOTHER
Xinjiang Medical University
CollaboratorOTHER
Gansu Provincial Hospital
CollaboratorOTHER
Tianjin Eye Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
corneal thicknesspreoperative

Secondary

MeasureTime frame
coma aberration measured by the Pentacam systempreoperative
aspherical index measured by the Pentacam systempreoperative
spherical aberration measured by the Pentacam systempreoperative
corrected distance visual acuitypreoperative
uncorrected distance visual acuitypreoperative
refractive diopterpreoperative
corneal curvature measured by the Pentacam systempreoperative
kapple angle measured by the Pentacam systempreoperative
introcular pressurepreoperative
corneal diameter measured by the Pentacam systempreoperative
anterior chamber depth measured by the Pentacam systempreoperative
anterior chamber angle measured by the Pentacam systempreoperative
corneal volume measured by the Pentacam systempreoperative

Countries

China

Contacts

Primary ContactYan Wang, director
wangyan7143@vip.sina.com+86-02227305083
Backup ContactLin Zhang
zhanglin_2015@126.com+86-02227305083

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026