Multi-center Ocular Biological Parameters Study

Cataract Clinical Trial

Official title:

Analysis of Eye Bioparametric Data of Chinese Population Based on Big Data

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04340635
• Other study ID #: SHIRB2018020
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2020
• Source: Aier School of Ophthalmology, Central South University
• Contact: xu chen
• Phone: 13601762646
• Email: Francois.chenxu[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is a multi-center study, which collects data from multiple regions to obtain the general biological characteristics of the Chinese population. The formula for calculating the artificial lens power based on foreign populations is effectively modified based on the Chinese population.

Description:

①Relevant domestic studies on the biological characteristics of the eye are mainly limited to a certain city and region. Most of the studies that represent the biological characteristics of the general population in China and the differences in biological parameters at home and abroad are in the research process, or Semi-finished products.

②The investigators found in clinical observation that the eyeball biological data of the Chinese population may not be consistent with the foreign population.

③ This study is the first study of human eye biological parameters based on different regions of large-scale populations in China, which is of great significance for understanding the human eye structure in different regions of China.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: December 31, 2020
• Est. primary completion date: October 1, 2020
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• patients aged over 50 years

Exclusion Criteria:

• history of refractive surgery,

• corneal diseases

• ocular inflammation

• trauma

Related Conditions & MeSH terms

• Cataract

Locations

Country	Name	City	State
China	Shanghai Aier Eye Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Aier School of Ophthalmology, Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	axial length (AL)	Measured using the partial coherence laser interferometry (IOLMaster, Carl Zeiss Meditec, Germany)	1 hour
Primary	anterior chamber depth (ACD)	Measured using the partial coherence laser interferometry (IOLMaster, Carl Zeiss Meditec, Germany)	1 hour
Primary	keratometric power (K)	Measured using the partial coherence laser interferometry (IOLMaster, Carl Zeiss Meditec, Germany)	1 hour
Primary	corneal astigmatism (CA)	Measured using the partial coherence laser interferometry (IOLMaster, Carl Zeiss Meditec, Germany)	1 hour