SESA: Shanghai Eye Study for Adults

• Sponsor: Shanghai Eye Disease Prevention and Treatment Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03455478
• Collaborator: Brien Holden Vision (Industry)
• Enrollment: 1,000,000
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 131
• Patients Per Site Per Month: 7636.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Blindness,Visual Impairment, Refractive Error, Cataract, High Myopia, Aging	Device: spectacles	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 1000000 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Screening
• Official Title: Shanghai Eye Study for Adults
• Actual Study Start Date: Jan 1, 2016
• Actual Primary Completion Date: Nov 30, 2019
• Anticipated Study Completion Date: Nov 30, 2026

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. best-corrected visual acuity (BCVA) [5 years]

   the prevalence of blindness and visual impairment

2. cataract surgery rate [5 years]

   cataract surgery rate of Shanghai older people

3. cataract surgery coverage rate [5 years]

   cataract surgery coverage rate of Shanghai cataract patients

4. visual impairment caused by high myopia [5 years]

   observing the rate of visual impairment caused by high myopia

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• shanghai residents aged ≥18 years old

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Eye Disease Prevention & Treatment Center	Shanghai	Shanghai	China	200040

Sponsors and Collaborators

• Shanghai Eye Disease Prevention and Treatment Center
• Brien Holden Vision

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shanghai Eye Disease Prevention and Treatment Center
• ClinicalTrials.gov Identifier: NCT03455478
• Other Study ID Numbers: YFZX2018001
• First Posted: Mar 6, 2018
• Last Update Posted: May 24, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Vision Disorders; Vision, Low; Blindness; Cataract; Refractive Errors

Study Results

No Results Posted as of May 24, 2022