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Cataract (Post-operative Cataract Surgery Follow-up)NCT07513402

Vision Center Determinants of Cataract Follow-Up in Rural India

A study testing Follow-Up Strengthening Intervention Framework in people with Cataract (Post-operative Cataract Surgery Follow-up), 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

Cataract remains the leading cause of avoidable blindness in India despite substantial expansion of surgical services over the past two decades. While surgical coverage has improved, optimal visual outcomes depend on effective post-operative follow-up, which remains inconsistent across decentralized Vision… Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
Follow-Up Strengthening Intervention Framework
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
No sites listed yet
Study dates
May 2026to Mar 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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥40 years
  • All cataract surgery types (e.g., SICS, phacoemulsification)
  • Advised Vision Center follow-up at discharge
  • Complete HMIS-VCMIS linkage

Who cannot join

  • Age <40 years
  • Non-cataract surgeries
  • No advised Vision Center follow-up

About this study

Official title: Facility-Level Determinants of Post-Operative Cataract Follow-Up Compliance: A Phased Mixed-Methods Implementation Study of Vision Center-Based Follow-Up Systems in Rural and Semi-Rural India.

Cataract remains the leading cause of avoidable blindness in India despite substantial expansion of surgical services over the past two decades. While surgical coverage has improved, optimal visual outcomes depend on effective post-operative follow-up, which remains inconsistent across decentralized Vision Center-based systems, particularly in rural and semi-urban settings. Routine program data show wide variation in post-operative cataract follow-up compliance among Vision Centers operating within similar organizational and geographic contexts, suggesting the influence of facility-level determinants.

This phased mixed-methods implementation study aims to identify facility-level factors influencing post-operative cataract follow-up compliance and to develop an evidence-based framework to strengthen follow-up systems. Phase 1 will involve retrospective analysis of three years of integrated Health Management Information System- Vision Centre Management Information System (HMIS-VCMIS) data from approximately 120 Vision Centers to establish empirical benchmarks and classify centers as high- or low-performing. Structured facility assessments and qualitative interviews with Vision Center staff, program managers, and post-operative patients will be conducted to identify operational practices, workflows, and contextual factors associated with follow-up performance.

Read more

Phase 2 will focus on co-design, pilot testing, and early implementation of a Follow-Up Strengthening Intervention Framework in selected low-performing Vision Centers. The intervention will include standardized counselling workflows, follow-up tracking and reminder systems, role clarification, supervisory feedback mechanisms, and peer-learning support from high-performing centers. Changes in follow-up compliance will be monitored using routine data over a 12-month implementation period, alongside process evaluation to assess feasibility, fidelity, and acceptability.

Findings from this study will generate practical evidence to strengthen post-operative cataract follow-up systems and inform scalable quality improvement strategies within decentralized Vision Center networks.

Read the detailed description

Cataract remains the leading cause of avoidable blindness in India, accounting for nearly two-thirds of blindness among adults aged 50 years and older. Over the past two decades, the expansion of cataract surgical services through public-private partnerships, outreach programs, and high-volume surgical models has significantly improved surgical coverage and access to care. However, increasing surgical coverage alone is insufficient to ensure optimal visual outcomes unless it is supported by effective post-operative follow-up care.

Post-operative cataract follow-up is a complex service delivery function that requires coordinated action between surgical hospitals, Vision Centers, and community-based systems. It is essential for early detection and management of complications, monitoring visual recovery, providing refractive correction, reinforcing post-surgical counselling, and accurately assessing surgical outcomes. Poor follow-up compliance can result in avoidable visual impairment, delayed treatment of complications, reduced patient satisfaction, and inaccurate assessment of surgical quality, thereby undermining the overall effectiveness of cataract programs.

Vision Centers (VCs) serve as decentralized eye care facilities providing continuity of care following cataract surgery, particularly in rural and semi-urban settings. By reducing travel distance, direct costs, and opportunity losses for patients, Vision Centers are intended to facilitate timely post-operative follow-up closer to patients' homes. Although often categorized as primary eye care facilities, in the context of cataract services they function as task-shifted platforms for post-operative follow-up and referral, linking secondary surgical care with community-level access.

Despite this decentralized model, routine program data indicate wide variation in post-operative follow-up compliance across Vision Centers. Some centers consistently achieve compliance rates exceeding 80%, while others remain below 60%, even within similar organizational, geographic, and programmatic contexts. This variability suggests that follow-up compliance is influenced not only by patient-level factors but also by facility-level and system-level determinants, including staffing patterns, counselling workflows, follow-up tracking mechanisms, documentation practices, community engagement strategies, and managerial or sponsor support. These facility-level determinants have not yet been systematically examined using an implementation-focused and evidence-based approach.

Definition of High- and Low-Performing Vision Centers

For the purpose of this study, Vision Centers will be categorized based on pooled three-year post-operative cataract follow-up compliance and consistency of performance over time:

  • High-Performing Vision Centers: Vision Centers achieving ≥80% post-operative follow-up compliance, consistently across at least two of the preceding three years.
  • Low-Performing Vision Centers: Vision Centers achieving ≤60% post-operative follow-up compliance, with persistently low performance across the same period.

Rationale Routine data from integrated Hospital Management Information Systems (HMIS) and Vision Center Management Information Systems (VCMIS) demonstrate persistent differences in post-operative cataract follow-up compliance across Vision Centers. The coexistence of high- and low-performing Vision Centers serving comparable populations within the same service delivery system provides an opportunity to identify modifiable facility-level determinants influencing follow-up adherence.

As cataract programs progressed, the primary challenge has shifted from increasing surgical volume to ensuring quality assurance and continuity of care. Post-operative follow-up remains a critical yet weakly institutionalized component of routine cataract service delivery. Facility-level practices influencing follow-up performance are poorly documented, insufficiently standardized, and inconsistently monitored. Addressing these gaps is essential to protect surgical outcomes and optimize returns on investment in cataract surgery programs.

Establishing empirical benchmarks based on high-performing Vision Centers and analytically identifying facilitators and barriers differentiating them from low-performing centers is therefore essential. A phased mixed-methods implementation research approach, linking retrospective analysis of routine data, structured facility assessments, and qualitative stakeholder inquiry, will allow a comprehensive examination of both quantitative performance patterns and the contextual factors shaping them.

Study Objectives Overall Objective To generate an evidence-based framework for strengthening post-operative cataract follow-up compliance within decentralized Vision Center-based follow-up systems in rural and semi-urban India.

Phase 1: Assessment (Months 0-8) Primary Objective 1 To determine an empirical benchmark for post-operative cataract follow-up compliance by analyzing retrospective data from high-performing Vision Centers over the preceding three years.

Primary Objective 2 To identify and compare facility-level facilitators and operational characteristics associated with high and low post-operative follow-up compliance through structured Vision Center assessments.

Secondary Objective To explore stakeholder perceptions, workflows, leadership practices, and contextual factors influencing post-operative follow-up adherence through qualitative interviews at high- and low-performing Vision Centers.

Phase 2: Intervention Design and Early Implementation (Months 9-26)

Phase 2 will involve:

  1. Co-design of a Follow-Up Strengthening Intervention Framework informed by Phase 1 findings and high-performing Vision Center practices.
  2. Pilot testing of the intervention in one or two low-performing Vision Centers for three months.
  3. Early implementation and evaluation of the refined intervention in selected low-performing Vision Centers over 12 months, using routine monitoring and structured process evaluation.

Conditions Conditions: Cataract (Post-operative Cataract Surgery Follow-up)

Keywords:

Cataract surgery, Community-based eye care, Continuity of care, Decentralized eye care, Facility-level determinants, Follow-up compliance, Mixed-methods study, Post-operative cataract care, Quality of care, Vision Centers

Study Design:

This is a phased mixed-methods study, comprising a retrospective observational study in Phase 1 and an intervention with early implementation in Phase 2.

Study Type:

Observational study with mixed-methods design focusing on implementation research and quality improvement at the facility level.

Primary Purpose:

To determine an empirical benchmark for post-operative cataract follow-up compliance and design and implement an evidence-based interventions aimed at strengthening post-operative follow-up systems at the vision centres.

Study Phase:

The study will be conducted in two sequential phases:

  • Phase 1-Assessment Phase: This phase involves retrospective analysis of routinely collected HMIS-VCMIS data and facility-level and qualitative assessments to establish baseline follow-up compliance rates, determine empirical benchmarks from high-performing Vision Centers, and identify key facilitators and barriers influencing follow-up compliance.
  • Phase 2 - Intervention and Early Implementation Phase: Based on findings from Phase 1, this phase will focus on the design and early implementation of evidence-based interventions aimed at strengthening post-operative follow-up systems. The interventions will primarily target low-performing Vision Centers to improve follow-up compliance, while sustaining and enhancing performance in high-performing Vision Centers.
Being tested
Follow-Up Strengthening Intervention Framework
Keywords
Cataract surgery, Community-based eye care, Continuity of care, Facility-level determinant, Follow-up compliance
Medical subject headings
Cataract

What participants receive

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

  • Follow-Up Strengthening Intervention FrameworkOther

    The intervention will include standardized counselling workflows, follow-up tracking and reminder systems, role clarification, supervisory feedback mechanisms, and peer-learning support from high-performing centers.

Study groups in NCT07513402
Study groupRoleWhat they receive
Compliance Improvement armExperimentalNot described
Receives: Other: Follow-Up Strengthening Intervention Framework

What is being measured

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

  1. Post-operative follow-up compliance

    The primary outcome will be defined as facility-level postoperative follow-up compliance, calculated as the proportion of cataract patients who complete at least one follow-up visit at a Vision Center within 1 month (±15 days) of surgery. The denominator will include patients advised to follow up with the Vision Center at discharge, and the numerator will include those who completed the follow-up within this time window. The outcome will be based on HMIS-VCMIS linked patient records and analyzed at the Vision Center level over a 12-month observation period.

    Measured: 12 months

Timeline

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

  1. First posted7 Apr 2026
  2. Study startMay 2026 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionMar 2028 (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
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07513402
Sponsor's protocol ID
SNC/IEC/2026-01/04/04
Status last verified
Apr 2026
First submitted
16 Mar 2026
Last updated
7 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Follow-Up Strengthening Intervention Framework in people with Cataract (Post-operative Cataract Surgery Follow-up), 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 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 7 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?

Post-operative follow-up compliance (time frame: 12 months). 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 7 Apr 2026.

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