Multi-center Ocular Biological Parameters Study

April 7, 2020 updated by: Aier School of Ophthalmology, Central South University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

20000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Select elderly cataract patients from different regions of China (at least one representative city in each of east, south, west, north, and central China) who were treated in Aier Eye Hospital.

Description

Inclusion Criteria:

  • patients aged over 50 years

Exclusion Criteria:

  • history of refractive surgery,
  • corneal diseases
  • ocular inflammation
  • trauma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Multi-center data collection
Without intervention

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aier School of Ophthalmology, Central South University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Anticipated)

October 1, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

March 29, 2020

First Submitted That Met QC Criteria

April 7, 2020

First Posted (Actual)

April 9, 2020

Study Record Updates

Last Update Posted (Actual)

April 9, 2020

Last Update Submitted That Met QC Criteria

April 7, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHIRB2018020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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