Shanghai Eye Study for Adults

NCT03455478 | Recruiting

• 1 other identifier: YFZX2018001
• Study Type: interventional
• Target: 1,000,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• best-corrected visual acuity (BCVA)

  the prevalence of blindness and visual impairment

  5 years

• cataract surgery rate

  cataract surgery rate of Shanghai older people

  5 years

• cataract surgery coverage rate

  cataract surgery coverage rate of Shanghai cataract patients

  5 years

• visual impairment caused by high myopia

  observing the rate of visual impairment caused by high myopia

  5 years

Study Arms (2)

corrected refractive error

EXPERIMENTAL

Device: spectacles

uncorrected refractive error

NO INTERVENTION

Interventions

spectacles DEVICE

dispending spectacles for uncorrected refractive error

corrected refractive error

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• shanghai residents aged ≥18 years old

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Eye Disease Prevention and Treatment Center: lead
• Brien Holden Vision: collaborator

Study Sites (1)

Shanghai Eye Disease Prevention & Treatment Center

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

MeSH Terms

Conditions

Blindness; Vision Disorders; Refractive Errors; Cataract

Interventions

Eyeglasses

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lens Diseases

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Central Study Contacts

Xun Xu, MD

CONTACT

8613386259538; drxuxun@tom.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2018
• First Posted: March 6, 2018
• Study Start: January 1, 2016
• Primary Completion: November 30, 2019
• Study Completion (Estimated): November 30, 2026
• Last Updated: May 24, 2022

Record last verified: 2022-05

Locations

CN (1)