Shanghai Eye Study for Adults (SESA)

May 17, 2022 updated by: Shanghai Eye Disease Prevention and Treatment Center
Blindness and visual impairment severely impact the visual health and life quality of people, particularly the 2.566 million senior citizens aged at 65 and above in Shanghai. The main reason is uncorrected refractive error, of which, 62.1% can be solved through refractive correction. For this reason, the uncorrected refractive errors of 154,000 senior citizens in Shanghai can be taken as a priority among the public health issues to prevent blindness. Now, with the aim to reduce the prevalence rate of blindness and visual impairment, it is planned to establish a public health service mechanism in terms of refractive error screening and correction for the elderly by relying on Shanghai's three-level (city-district-community) eye diseases prevention network, using proper refractive correction technology, and moving related services forward to communities in order to screen, identity, and correct blindness and visual impairment caused by refractive errors as early as possible.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1000000

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200040
        • Recruiting
        • Shanghai Eye Disease Prevention & Treatment Center

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

16 years to 98 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • shanghai residents aged ≥18 years old

Exclusion Criteria:

  • cognitive and/or mobility disorders; non-shanghai residents; younger than 18 years old.

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

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: corrected refractive error
Device: spectacles
dispending spectacles for uncorrected refractive error
No Intervention: uncorrected refractive error

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
best-corrected visual acuity (BCVA)
Time Frame: 5 years
the prevalence of blindness and visual impairment
5 years
cataract surgery rate
Time Frame: 5 years
cataract surgery rate of Shanghai older people
5 years
cataract surgery coverage rate
Time Frame: 5 years
cataract surgery coverage rate of Shanghai cataract patients
5 years
visual impairment caused by high myopia
Time Frame: 5 years
observing the rate of visual impairment caused by high myopia
5 years

Collaborators and Investigators

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

Sponsor

Shanghai Eye Disease Prevention and Treatment Center

Collaborators

Brien Holden Vision

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, 2016

Primary Completion (Actual)

November 30, 2019

Study Completion (Anticipated)

November 30, 2026

Study Registration Dates

First Submitted

February 10, 2018

First Submitted That Met QC Criteria

February 27, 2018

First Posted (Actual)

March 6, 2018

Study Record Updates

Last Update Posted (Actual)

May 24, 2022

Last Update Submitted That Met QC Criteria

May 17, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YFZX2018001

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.

Clinical Trials on Blindness,Visual Impairment, Refractive Error, Cataract, High Myopia, Aging

Clinical Trials on spectacles

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kazakhstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe