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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

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Jan 2016, registered Feb 2018).
  • Started Jan 2016; still recruiting 10 years 10 months later.
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

In context

Blindness

144 studies on the registry are indexed under Blindness; 33 are open to participants now.

This study's planned enrollment of 1,000,000 is above the median of 37 across 101 interventional studies indexed under Blindness.

Browse Blindness studies →

Lead sponsor

Shanghai Eye Disease Prevention and Treatment Center is the lead sponsor of 66 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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.
05

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

06

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2016 to primary completion in Nov 2019, 46 months.

Of 36 interventional studies with no phase under Blindness, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 19. This study's 46 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 10, 2018
First posted
Mar 6, 2018
StartActual
Jan 1, 2016
Primary completionActual
Nov 30, 2019
CompletionEst.
Nov 30, 2026
Last update
May 24, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 24, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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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