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

Cornea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03010748
• Other study ID #: Tianjin EH-pentacam
• Status: Recruiting
• Start date: November 2015
• Est. completion date: December 2019

Study information

• Verified date: May 2018
• Source: Tianjin Eye Hospital
• Contact: Yan Wang, director
• Phone: +86-02227305083
• Email: wangyan7143[@]vip.sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50000
• Est. completion date: December 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cornea

Intervention

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.

Locations

Country	Name	City	State
China	Tianjin Eye Hospital	Tianjin

Sponsors (7)

Lead Sponsor	Collaborator
Tianjin Eye Hospital	Gansu Provincial Hospital, Health Science Center of Xi’an Jiaotong University, Jilin University, Second People's Hospital of Yunnan Province, Wuhan General Hospital of Guangzhou Military Command, Xinjiang Medical University

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View Citation

Naderan M, Rajabi MT, Zarrinbakhsh P, Farjadnia M. Is keratoconus more severe in pediatric population? Int Ophthalmol. 2016 Oct 25. [Epub ahead of print] — View Citation

Patrão LF, Canedo AL, Azevedo JL, Correa R, Ambrósio 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	corneal thickness		preoperative
Secondary	corneal curvature measured by the Pentacam system		preoperative
Secondary	coma aberration measured by the Pentacam system		preoperative
Secondary	aspherical index measured by the Pentacam system		preoperative
Secondary	spherical aberration measured by the Pentacam system		preoperative
Secondary	corrected distance visual acuity		preoperative
Secondary	uncorrected distance visual acuity		preoperative
Secondary	refractive diopter		preoperative
Secondary	corneal volume measured by the Pentacam system		preoperative
Secondary	kapple angle measured by the Pentacam system		preoperative
Secondary	introcular pressure		preoperative
Secondary	corneal diameter measured by the Pentacam system		preoperative
Secondary	anterior chamber depth measured by the Pentacam system		preoperative
Secondary	anterior chamber angle measured by the Pentacam system		preoperative

External Links

•   Combined tomography and epithelial thickness mapping for diagnosis of keratoconus.
•   Comparison of corneal measurements in keratoconus using swept-source optical coherence tomography and combined Placido-Scheimpflug imaging
•   Differentiation of mild keratoconus from corneal warpage according to topographic inferior steepening based on corneal tomography data
•   Is keratoconus more severe in pediatric population?