Cataract SurgeryNCT07227714
Effect of Vision Centers on Access to Eye Care and Eye Health Outcomes
A study testing Establishment of a vision center in people with Cataract Surgery and Eye Care, run by University of California, San Francisco at 1 site in United States.
Trial summary
This cluster-randomized trial aims to evaluate the effect of vision centers on access to eye care and eye health outcomes in South Asia. The main questions it aims to answer are: 1. Do vision centers improve effective refractive error coverage? 2. Do vision centers increase eye care center utilization? 3. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cataract Surgery, Eye Care, Glasses
- What is being tested?
- Establishment of a vision center
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2026to 1 Dec 2028
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- The catchment area of the proposed VC site is predominantly rural.
- The proposed VC site is located within 20-100 km of the base hospital.
- There are no major primary eye care services within 10 km of the proposed site.
- Care at sites randomized to establish VCs immediately is accessible to anyone.
Who cannot join
- Sites located in non-rural or urban catchment areas.
- Sites outside the 20-100 km distance range from the base hospital.
- Sites with existing major primary eye care services within a 10 km radius.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of California, San Francisco
San Francisco, California, 94158
About this study
Official title: A Cluster-Randomized Trial Evaluating the Effect of Vision Centers on Access to Eye Care and Eye Health Outcomes in South Asia
This cluster-randomized trial aims to evaluate the effect of vision centers on access to eye care and eye health outcomes in South Asia. The main questions it aims to answer are:
- Do vision centers improve effective refractive error coverage?
- Do vision centers increase eye care center utilization?
- Do vision centers improve population visual acuity?
Researchers will compare outcomes in communities randomized to immediate versus delayed establishment of a vision center. Outcomes will be assessed through population-based surveys at baseline and after two years as well as through hospital records collected throughout the study period.
Read the detailed description
The vast majority of visual impairment and blindness is preventable or treatable with existing interventions. Nearly all of this burden is faced by those living in low- and middle-income countries. Access to eye care is a key challenge in these settings, particularly in rural and remote areas.
Vision centers (VCs) have been developed to increase access to primary eye care in such underserved settings. VCs typically involve establishment of a fixed center staffed by a mid-level ophthalmic technician who offers refraction, spectacles, diagnosis and treatment of basic eye conditions, and referrals for more complex care. VCs have become a common approach to increase access to care in many low- and middle-income country settings, yet little rigorous evidence exists on their impact on eye health in the communities they serve. A recent literature review was unable to identify randomized controlled trials on the impact of vision centers on eye health outcomes in real world settings. While the observational research that exists suggests VCs improve eye health in the communities they serve, the existing evidence is prone to bias.
The investigators propose a cluster-randomized trial to evaluate the effect of VCs on access to eye care and eye health outcomes in South Asia. The trial will leverage VCs planned by the Seva Foundation and partners Bangladesh, India, and Nepal and will monitor outcomes via population-based surveys and hospital network records over 2 years. The investigators expect to provide rigorous evidence on VC impact in real-world settings that can be used to influence programmatic decision making and policy.
- Conditions
- Cataract Surgery, Eye Care, Glasses, Primary Eye Care, Vision Center, Eyecare Visits
- Being tested
- Establishment of a vision center
- Keywords
- vision center, primary eye care, cataract surgery, glasses, glassess ownership, spectacle ownership, cluster-randomized trial, eyecare visits
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Establishment of a vision centerOther
The establishment of a vision center includes building a fixed center, and equipping it with a trained vision technician to provide basic eye care services such as refractive error correction, spectacle dispensing, basic diagnosis for common conditions, as well as referrals for advanced care at base hospitals. The establishment of VCs will be actively publicized in the neighboring communities through promotion by local stakeholders, teachers, community workers, village leaders, health workers, and radio announcements prior to establishment. Additional outreach activities include posters and loudspeaker announcements in the communities the day before operations begin.
| Study group | Role | What they receive |
|---|---|---|
| Immediate establishment of a vision center | Experimental | The intervention arm will include the establishment of a fixed vision center equipped with trained vision technicians to provide basic eye care services and referrals to higher care. Receives: Other: Establishment of a vision center |
| Delayed establishment of a vision center | No intervention | The control arm will receive standard of care during the study period. The establishment of a vision center will occur after endline data collection, if hospital interest and resources remain adequate. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective refractive error coverage
Proportion of survey participants with met need for distance refractive error correction with good quality vision of 6/12 or better in the better seeing eye among the total number of people in need (met need + undermet need + unmet need).
Measured: 2 years
Secondary outcomes (10)
Prevalence of eyecare visits
Prevalence of eyecare visits completed in the past one year, defined for each cluster as the number of individuals self-reporting having completed at least one visit in the past year divided by the total number of individuals surveyed.
Measured: 1 year
Mean presenting and pinhole visual acuity
Mean presenting and pinhole visual acuity (logMAR) as assessed during the survey.
Measured: 2 years
Near vision effective refractive error coverage
Proportion of survey participants with met need for near vision correction with good quality vision of N6 or better among the total number of people in need of near vision correction (met need + undermet neet + unmet need)
Measured: 2 years
Effective cataract surgical coverage
Proportion of survey participants with met need for cataract surgery with a good-quality outcome of presenting visual acuity 6/12 or better among the total number of people who have had or are in need of cataract surgery
Measured: 2 years
Prevalence of current spectacle ownership
Prevalence of current spectacle ownership assessed during the population-based survey.
Measured: 2 years.
Prevalence of spectacle wearing
Prevalence of spectacle wearing as assessed during the survey.
Measured: 2 years
Prevalence of visual impairment
Visual impairment is defined as presenting visual acuity worse than logMAR 0.54 in the better-seeing eye as assessed during the population-based survey.
Measured: 2 years
Prevalence of blindness
Blindness is defined as presenting visual acuity worse than logMAR 1.30 in the better-seeing eye as assessed during the population-based survey.
Measured: 2 years
Prevalence of employment
Prevalence of employment as assessed during the population-based survey.
Measured: 2 years
Prevalence of individuals with caregiving responsibilities for visually impaired household members
Prevalence of individuals with caregiving responsibilities for visually impaired household members assessed during the population-based survey.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2025
- Study start1 Aug 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract SurgeryStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Seva Foundation, Proctor Foundation
- Responsible party
- Sponsor
- Investigators
- Kieran O'Brien, PhD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07227714
- Sponsor's protocol ID
- 25-45086
- Status last verified
- Jun 2026
- First submitted
- 10 Nov 2025
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified cluster-level data will be shared publicly via osf.io
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster-Randomized Trial Evaluating the Effect of Vision Centers on Access to Eye Care and Eye Health Outcomes in South Asia
- ClinicalTrials.gov ID
- NCT07227714
- Acronym / sponsor ID
- 25-45086
- Conditions
- Cataract Surgery, Eye Care, Glasses, Primary Eye Care, Vision Center, Eyecare Visits
- Keywords
- vision center, primary eye care, cataract surgery, glasses, glassess ownership, spectacle ownership, cluster-randomized trial, eyecare visits
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150,000 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Seva Foundation, Proctor Foundation
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 13 Nov 2025 (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.
This cluster-randomized trial aims to evaluate the effect of vision centers on access to eye care and eye health outcomes in South Asia. The main questions it aims to answer are:
- Do vision centers improve effective refractive error coverage?
- Do vision centers increase eye care center utilization?
- Do vision centers improve population visual acuity?
Researchers will compare outcomes in communities randomized to immediate versus delayed establishment of a vision center. Outcomes will be assessed through population-based surveys at baseline and after two years as well as through hospital records collected throughout the study period.
Detailed description
The vast majority of visual impairment and blindness is preventable or treatable with existing interventions. Nearly all of this burden is faced by those living in low- and middle-income countries. Access to eye care is a key challenge in these settings, particularly in rural and remote areas.
Vision centers (VCs) have been developed to increase access to primary eye care in such underserved settings. VCs typically involve establishment of a fixed center staffed by a mid-level ophthalmic technician who offers refraction, spectacles, diagnosis and treatment of basic eye conditions, and referrals for more complex care. VCs have become a common approach to increase access to care in many low- and middle-income country settings, yet little rigorous evidence exists on their impact on eye health in the communities they serve. A recent literature review was unable to identify randomized controlled trials on the impact of vision centers on eye health outcomes in real world settings. While the observational research that exists suggests VCs improve eye health in the communities they serve, the existing evidence is prone to bias.
The investigators propose a cluster-randomized trial to evaluate the effect of VCs on access to eye care and eye health outcomes in South Asia. The trial will leverage VCs planned by the Seva Foundation and partners Bangladesh, India, and Nepal and will monitor outcomes via population-based surveys and hospital network records over 2 years. The investigators expect to provide rigorous evidence on VC impact in real-world settings that can be used to influence programmatic decision making and policy.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate establishment of a vision center | Experimental | Other: Establishment of a vision centerThe intervention arm will include the establishment of a fixed vision center equipped with trained vision technicians to provide basic eye care services and referrals to higher care. |
| Delayed establishment of a vision center | No intervention | –The control arm will receive standard of care during the study period. The establishment of a vision center will occur after endline data collection, if hospital interest and resources remain adequate. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- The catchment area of the proposed VC site is predominantly rural.
- The proposed VC site is located within 20-100 km of the base hospital.
- There are no major primary eye care services within 10 km of the proposed site.
- Care at sites randomized to establish VCs immediately is accessible to anyone.
Key exclusion criteria (3 listed)
- Sites located in non-rural or urban catchment areas.
- Sites outside the 20-100 km distance range from the base hospital.
- Sites with existing major primary eye care services within a 10 km radius.
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 |
|---|---|---|
| Establishment of a vision centerThe establishment of a vision center includes building a fixed center, and equipping it with a trained vision technician to provide basic eye care services such as refractive error correction, spectacle dispensing, basic diagnosis for common conditions, as well as referrals for advanced care at base hospitals. The establishment of VCs will be actively publicized in the neighboring communities through promotion by local stakeholders, teachers, community workers, village leaders, health workers, and radio announcements prior to establishment. Additional outreach activities include posters and loudspeaker announcements in the communities the day before operations begin. | Other | Immediate establishment of a vision center |
Primary outcome
Effective refractive error coverage
Time frame: 2 years
Proportion of survey participants with met need for distance refractive error correction with good quality vision of 6/12 or better in the better seeing eye among the total number of people in need (met need + undermet need + unmet need).
10 secondary outcomes
Prevalence of eyecare visits
Time frame: 1 year
Mean presenting and pinhole visual acuity
Time frame: 2 years
Near vision effective refractive error coverage
Time frame: 2 years
Effective cataract surgical coverage
Time frame: 2 years
Prevalence of current spectacle ownership
Time frame: 2 years.
Prevalence of spectacle wearing
Time frame: 2 years
Prevalence of visual impairment
Time frame: 2 years
Prevalence of blindness
Time frame: 2 years
Prevalence of employment
Time frame: 2 years
Prevalence of individuals with caregiving responsibilities for visually impaired household members
Time frame: 2 years
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 30 Jun 2026.
- Individual participant dataSharing planned: Yes. De-identified cluster-level data will be shared publicly via osf.io
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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.
Kieran O'Brien, PhD, MPH principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Establishment of a vision center in people with Cataract Surgery and Eye Care, run by University of California, San Francisco at 1 site in United States.
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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 30 Jun 2026. 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 United States. 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 Kieran O'Brien, PhD, MPH (415-514-2163, Kieran.OBrien@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective refractive error coverage (time frame: 2 years). 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 30 Jun 2026.