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Health ServicesNCT07547527

Evaluating the Integration Model of a Standalone Eye Centre Into Provincial Government Hospital

A study testing Vision Centre Integration in people with Health Services and Ophthalmology Services, run by Seva Canada Society.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

This study aims to evaluate the integration of a standalone eye centre into the Provincial Government Hospital in Kalaiya, Bara District, Nepal. The integration model seeks to improve access to comprehensive eye care services by combining the specialized expertise of an eye care facility with the infrastructure and… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Vision Centre Integration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
Jun 2026to Dec 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All individuals receiving eye-care services at the Kalaiya Eye Centre before and after integration.
  • Patients from Bara district and catchment areas
  • Patients attending eye services during study period
  • New and follow-up patients

Who cannot join

  • Patients outside catchment area (e.g., non-Nepalese)
  • Incomplete or missing records

About this study

Official title: Evaluating the Integration Model of a Standalone Eye Centre Into Provincial Government Hospital: A Case Study From Kalaiya, Bara District, Nepal

This study aims to evaluate the integration of a standalone eye centre into the Provincial Government Hospital in Kalaiya, Bara District, Nepal. The integration model seeks to improve access to comprehensive eye care services by combining the specialized expertise of an eye care facility with the infrastructure and patient flow of a provincial hospital. As the burden of avoidable visual impairment remains high in Nepal, strengthening service delivery at the district level has the potential to improve early detection, timely treatment, and continuity of care. 1 A mixed-method approach will be used to assess changes in service utilization patterns for example patient volume, follow ups and referrals following the integration. Additional focus will be placed on the acceptability of the integration model among patients, eye care professionals, and the hospital staff. This study will help to generate evidence-based recommendations to guide district-level planning for integrated eye care models by 2027.

Data will be collected from patient records, hospital statistics, patient and staff interviews. The findings are expected to provide evidence on the feasibility, challenges, and benefits of integrating specialized eye care units into provincial hospital systems in low-resource settings. Ultimately, the study aims to inform policy decisions, support scalable models of eye care integration, and contribute to improved eye health outcomes for underserved populations.

Read the detailed description

Worldwide there are 36.0 million blind and 216.6 million visually impaired. Of these, the majority of cases are preventable or treatable. With most eye care being delivered through secondary and tertiary levels of the health system, initial access to services remains a barrier to addressing visual impairment. A key approach to improving access is the integration of eye care into primary health care to provide treatment and referral at the lowest population level to identify those in need of eye health services.2 Visual impairment remains a significant public health concern in Nepal, particularly in rural and peri-urban regions where access to specialized eye care is limited. District-level hospitals represent the primary point of care for substantial segments of the population; however, these facilities frequently lack the ophthalmic infrastructure, skilled personnel, and diagnostic capacity required to address the growing burden of ocular morbidity. Standalone eye centers, often operated by non-governmental or semi-autonomous entities, have historically supplemented government services and played a critical role in delivering specialized ophthalmic care. Despite their strengths, these centers commonly function in parallel to the public health system, resulting in fragmented service delivery, inconsistent referral pathways, and challenges in long-term care coordination.3 This study aims to undertake a comprehensive academic evaluation of the integration of a standalone eye centre into the Provincial Government Hospital in Kalaiya, Bara District, Nepal. The initiative seeks to merge the specialized clinical capabilities and equipment resources of the Kalaiya Eye Centre (KEC) with the infrastructural capacity, patient volume, and administrative governance of the Provincial Government Hospital. This type of integration model represents an innovative approach to strengthening district-level eye care by enhancing system cohesion and optimizing resource utilization. Rigorous assessment of this model is necessary to determine its feasibility, operational efficiency, scalability, and potential contribution to strengthening Nepal's eye health system.4 The primary objectives of the study are to Compare patient service utilization (outpatient visits, follow ups, referrals) before and after integration. Secondary objectives include, to assess patient and community perceptions of accessibility, convenience, and quality of eye care services following integration.

A mixed-method research design will be employed to enable a holistic understanding of the integration process. Quantitative data will be extracted from electronic and paper-based service statistics, hospital records, and patient registries. This dataset will include indicators such as patient volume, follow ups and referrals. Statistical analyses will be undertaken to compare pre-integration and post-integration performance across these parameters, with the aim of identifying measurable improvements or persistent gaps.

Qualitative data will be obtained through semi-structured interviews, focus group discussions, and direct observational assessments involving ophthalmologists, optometrists, administrative personnel, and patients. The qualitative component will enable an in-depth examination of staff perceptions, workflow adaptations, communication pathways, patient experiences, and broader contextual factors influencing the success of the integration.

The integration will be examined not only in terms of structural reorganization but also as a dynamic process requiring alignment of institutional cultures, adaptation of workflows, and development of collaborative mechanisms. This perspective is critical for understanding integration as a multifaceted intervention that extends beyond infrastructural consolidation and entails significant organizational transformation.

The expected outcomes of the study include evidence on the extent to which integration improves patient access to timely ophthalmic evaluations, reduces unnecessary delays, and strengthens continuity of care.

This evaluation aligns with Nepal's broader commitments to Universal Eye Health and the national objective of reducing avoidable blindness. Strengthening eye care at the district level is central to achieving equitable service distribution and ensuring that underserved and marginalized populations receive timely, high-quality ophthalmic care. Findings from this study have the potential to inform policy decisions, guide health system strengthening efforts, and contribute to the development of evidence-based models for integrating specialized eye services into public hospital settings.

By providing a rigorous academic assessment of the integration model at Kalaiya, this study aims to contribute to the global discourse on health system integration and collaborative service delivery in low- and middle-income countries. The results are expected to offer transferable insights relevant to other regions seeking to harmonize parallel service structures, improve care coordination, and build more resilient and efficient eye health systems.

Being tested
Vision Centre Integration
Keywords
Eye care integration, Ophthalmology services, Health service accessibility, Eye Health delivery, Vision disorders
Medical subject headings
Vision Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vision Centre IntegrationOther

    Patients receiving services after integration into provincial hospital.

Study groups in NCT07547527
Study groupRoleWhat they receive
Post-Integration GroupExperimentalPatients receiving services after integration into provincial hospital.
Receives: Other: Vision Centre Integration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Outcome Measure: Change in patient service utilization • OPD visits • Follow-up visits • Referrals

    Measured: 6 months pre-integration vs 6 months post-integration

Secondary outcomes (1)
  1. Change in patient perception of accessibility and quality of services

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2026
  2. Study startJun 2026 (estimated)
  3. Primary completionNov 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07547527
Sponsor's protocol ID
KEH-DGH-INT-2025-01
Status last verified
Apr 2026
First submitted
17 Apr 2026
Last updated
23 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Vision Centre Integration in people with Health Services and Ophthalmology Services, run by Seva Canada Society.

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 2 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 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Outcome Measure: Change in patient service utilization • OPD visits • Follow-up visits • Referrals (time frame: 6 months pre-integration vs 6 months post-integration). 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 23 Apr 2026.

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