Shanghai Eye Study for Adults (SESA)
Primary Purpose
Blindness,Visual Impairment, Refractive Error, Cataract, High Myopia, Aging
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
spectacles
Sponsored by
About this trial
This is an interventional screening trial for Blindness,Visual Impairment, Refractive Error, Cataract, High Myopia, Aging
Eligibility Criteria
Inclusion Criteria:
- shanghai residents aged ≥18 years old
Exclusion Criteria:
- cognitive and/or mobility disorders; non-shanghai residents; younger than 18 years old.
Sites / Locations
- Shanghai Eye Disease Prevention & Treatment CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
corrected refractive error
uncorrected refractive error
Arm Description
Outcomes
Primary Outcome Measures
best-corrected visual acuity (BCVA)
the prevalence of blindness and visual impairment
cataract surgery rate
cataract surgery rate of Shanghai older people
cataract surgery coverage rate
cataract surgery coverage rate of Shanghai cataract patients
visual impairment caused by high myopia
observing the rate of visual impairment caused by high myopia
Secondary Outcome Measures
Full Information
NCT ID
NCT03455478
First Posted
February 10, 2018
Last Updated
May 17, 2022
Sponsor
Shanghai Eye Disease Prevention and Treatment Center
Collaborators
Brien Holden Vision
1. Study Identification
Unique Protocol Identification Number
NCT03455478
Brief Title
Shanghai Eye Study for Adults
Acronym
SESA
Official Title
Shanghai Eye Study for Adults
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
November 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Eye Disease Prevention and Treatment Center
Collaborators
Brien Holden Vision
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blindness,Visual Impairment, Refractive Error, Cataract, High Myopia, Aging
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
1000000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
corrected refractive error
Arm Type
Experimental
Arm Title
uncorrected refractive error
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
spectacles
Intervention Description
dispending spectacles for uncorrected refractive error
Primary Outcome Measure Information:
Title
best-corrected visual acuity (BCVA)
Description
the prevalence of blindness and visual impairment
Time Frame
5 years
Title
cataract surgery rate
Description
cataract surgery rate of Shanghai older people
Time Frame
5 years
Title
cataract surgery coverage rate
Description
cataract surgery coverage rate of Shanghai cataract patients
Time Frame
5 years
Title
visual impairment caused by high myopia
Description
observing the rate of visual impairment caused by high myopia
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
shanghai residents aged ≥18 years old
Exclusion Criteria:
cognitive and/or mobility disorders; non-shanghai residents; younger than 18 years old.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xun Xu, MD
Phone
8613386259538
Email
drxuxun@tom.com
Facility Information:
Facility Name
Shanghai Eye Disease Prevention & Treatment Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xun Xu, MD
Phone
86-13386259538
Email
drxuxun@tom.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Shanghai Eye Study for Adults
We'll reach out to this number within 24 hrs