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RecruitingNCT03455478SESAUpdated May 24, 2022

Shanghai Eye Study for Adults

An interventional study of spectacles in Blindness,Visual Impairment, Refractive Error, Cataract, High Myopia, Aging, sponsored by Shanghai Eye Disease Prevention and Treatment Center. Recruiting at 1 site in China. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-24.

Sponsored by Shanghai Eye Disease Prevention and Treatment Center · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
1,000,000
Allocation
Non-randomized
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Blindness,Visual Impairment, Refractive Error, Cataract, High Myopia, Aging
03

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • shanghai residents aged ≥18 years old

Exclusion criteria

Exclusion Criteria:

  • cognitive and/or mobility disorders; non-shanghai residents; younger than 18 years old.
04

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
Single (Outcomes assessor)
Enrollment
1,000,000 participants (estimated)

Study arms

  • Experimental
    corrected refractive error

    Device: spectacles

  • No intervention
    uncorrected refractive error

Interventions

  • Devicespectacles

    dispending spectacles for uncorrected refractive error

05

What researchers measure

Primary outcomes

  1. best-corrected visual acuity (BCVA)

    the prevalence of blindness and visual impairment

    Time frame: 5 years

  2. cataract surgery rate

    cataract surgery rate of Shanghai older people

    Time frame: 5 years

  3. cataract surgery coverage rate

    cataract surgery coverage rate of Shanghai cataract patients

    Time frame: 5 years

  4. visual impairment caused by high myopia

    observing the rate of visual impairment caused by high myopia

    Time frame: 5 years

06

Study locations

1 of 1 sites recruiting
  • Shanghai Eye Disease Prevention & Treatment Center
    Shanghai, Shanghai 200040, China
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03455478
Lead sponsor
Shanghai Eye Disease Prevention and Treatment Center
Collaborators
Brien Holden Vision
Responsible party
Sponsor
First posted
Mar 6, 2018
Start date
Jan 1, 2016
Primary completion
Nov 30, 2019
Completion
Nov 30, 2026 (estimated)
Last update
May 24, 2022

Study contacts

Xun Xu, MD
Contact
drxuxun@tom.com
8613386259538

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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