Blindness,Visual Impairment, Refractive Error, Cataract, High Myopia, AgingSESANCT03455478
Shanghai Eye Study for Adults
A study testing spectacles in people with Blindness,Visual Impairment, Refractive Error, Cataract, High Myopia, Aging, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Blindness,Visual Impairment, Refractive Error, Cataract, High Myopia, Aging
- What is being tested?
- spectacles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2016to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- shanghai residents aged ≥18 years old
Who cannot join
- cognitive and/or mobility disorders; non-shanghai residents; younger than 18 years old.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Eye Disease Prevention & Treatment Center
Shanghai, Shanghai Municipality, 200040
Xun Xu, MD, 86-13386259538, drxuxun@tom.com
About this study
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.
- Being tested
- spectacles
- Medical subject headings
- Blindness, Vision Disorders, Refractive Errors, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spectaclesDevice
dispending spectacles for uncorrected refractive error
| Study group | Role | What they receive |
|---|---|---|
| corrected refractive error | Experimental | Not described Receives: Device: spectacles |
| uncorrected refractive error | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
best-corrected visual acuity (BCVA)
the prevalence of blindness and visual impairment
Measured: 5 years
cataract surgery rate
cataract surgery rate of Shanghai older people
Measured: 5 years
cataract surgery coverage rate
cataract surgery coverage rate of Shanghai cataract patients
Measured: 5 years
visual impairment caused by high myopia
observing the rate of visual impairment caused by high myopia
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start1 Jan 2016
- Primary completion30 Nov 2019
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blindness,Visual Impairment, Refractive Error, Cataract, High Myopia, AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,000,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Sponsor type
- University, hospital or other
- Collaborators
- Brien Holden Vision
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03455478
- Sponsor's protocol ID
- YFZX2018001
- Acronym
- SESA
- Status last verified
- May 2022
- First submitted
- 10 Feb 2018
- Last updated
- 24 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shanghai Eye Study for Adults
- ClinicalTrials.gov ID
- NCT03455478
- Acronym / sponsor ID
- SESA / YFZX2018001
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000,000 participants (estimated)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Collaborators
- Brien Holden Vision
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 6 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| corrected refractive error | Experimental | Device: spectacles |
| uncorrected refractive error | No intervention | – |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- shanghai residents aged ≥18 years old
Key exclusion criteria (1 listed)
- cognitive and/or mobility disorders; non-shanghai residents; younger than 18 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spectaclesdispending spectacles for uncorrected refractive error | Device | corrected refractive error |
Primary outcome
best-corrected visual acuity (BCVA)
Time frame: 5 years
the prevalence of blindness and visual impairment
cataract surgery rate
Time frame: 5 years
cataract surgery rate of Shanghai older people
cataract surgery coverage rate
Time frame: 5 years
cataract surgery coverage rate of Shanghai cataract patients
visual impairment caused by high myopia
Time frame: 5 years
observing the rate of visual impairment caused by high myopia
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spectacles in people with Blindness,Visual Impairment, Refractive Error, Cataract, High Myopia, Aging, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xun Xu, MD (8613386259538, drxuxun@tom.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
best-corrected visual acuity (BCVA) (time frame: 5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022.