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Shanghai Eye Study for Older People (SESOP)

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ClinicalTrials.gov Identifier: NCT03455478
Recruitment Status : Recruiting
First Posted : March 6, 2018
Last Update Posted : March 6, 2018
Sponsor:
Collaborator:
Brien Holden Vision
Information provided by (Responsible Party):
Shanghai Eye Disease Prevention and Treatment Center

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Shanghai Eye Study for Older People
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: corrected refractive error Device: spectacles
dispending spectacles for uncorrected refractive error

No Intervention: uncorrected refractive error



Primary Outcome Measures :
  1. best-corrected visual acuity (BCVA) [ Time Frame: 2 years ]
    the prevalence of blindness and visual impairment

  2. cataract surgery rate [ Time Frame: 2 years ]
    cataract surgery rate of Shanghai older people

  3. cataract surgery coverage rate [ Time Frame: 2 years ]
    cataract surgery coverage rate of Shanghai cataract patients

  4. visual impairment caused by high myopia [ Time Frame: 2 years ]
    observing the rate of visual impairment caused by high myopia



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Ages Eligible for Study:   60 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • shanghai residents with age over than 60 years old

Exclusion Criteria:

  • cognitive disorders; non-shanghai residents; ≤ 60 years old;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03455478


Contacts
Contact: Xun Xu, MD 8613386259538 drxuxun@tom.com

Locations
China, Shanghai
Shanghai Eye Disease Prevention & Treatment Center Recruiting
Shanghai, Shanghai, China, 200040
Contact: Xun Xu, MD    86-13386259538    drxuxun@tom.com   
Sponsors and Collaborators
Shanghai Eye Disease Prevention and Treatment Center
Brien Holden Vision

Responsible Party: Shanghai Eye Disease Prevention and Treatment Center
ClinicalTrials.gov Identifier: NCT03455478     History of Changes
Other Study ID Numbers: YFZX2018001
First Posted: March 6, 2018    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
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
Cataract
Refractive Errors
Vision, Low
Blindness
Lens Diseases
Eye Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms