Health TrialsbyHealthPanel

Effect of Vision Centers on Access to Eye Care and Eye Health Outcomes

ConditionsCataract SurgeryEye CareGlassesPrimary Eye CareVision CenterEyecare Visits
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of California, San Francisco

About this trial

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. 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Establishment of a vision center

    Other intervention

    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.

Treatment groups

150,000 Participants
are divided into 2 treatment groups
Group A: Immediate establishment of a vision centerExperimental treatment 1 intervention
Group B: Delayed establishment of a vision centerNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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).

Time frame
2 years

Secondary outcomes

1

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.

Time frame
1 year
2

Mean presenting and pinhole visual acuity

Mean presenting and pinhole visual acuity (logMAR) as assessed during the survey.

Time frame
2 years
3

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)

Time frame
2 years
4

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

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

Seva Foundation

Collaborator

Proctor Foundation

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: