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Not yet recruitingNCT07333248Updated May 14, 2026

Strengthening Community- to- Hospital Eye Care Pathways From Boko Eye Care Center in Rural Assam

An interventional study of Experimental: Integrated Referral and Engagement Model in Cataract and Refractive Errors, sponsored by Seva Canada Society. Not yet recruiting at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-14.

Sponsored by Seva Canada Society · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
2,000
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 36 studies in Cataract with a site in India — 5 open to participants now, 5 under way, none of them phase 3. Cataract · India.

Planned enrollment
Largest of 25
2,000 · median 120
Started
2026
with 2 others
No phase
12 of 36
4 open now
Registered
34th of 36
by date
Lead sponsor
2 of 36
Seva Canada Society

Among the 36 studies in Cataract with a site in India, this one has the largest planned enrollment of the 25 interventional ones, is one of 3 that started in 2026, is one of 12 with no phase, and was the 34th registered.

By phase

36 studies; the count open now beside each. This study's row is marked.

No phasethis study12 · 4 open
Observational11 · 1 open
Phase 48 · 0 open
Phase 35 · 0 open

By the year they started

First in 2003; this study’s year is marked. 3 started in 2026.

Size and results

Median enrollment 120 across the 25 interventional studies, 99 across the 11 observational. Of the 26 that completed or were terminated, 4 (15%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 36 studies in Cataract with a site in India, or all of them as a file.
02

Study summary

This operational research project aims to strengthen continuity of eye care delivery between community screening and hospital-based treatment in rural Assam by redesigning referral pathways from the Boko Eye Care Center (ECC) to Sri Sankaradeva Nethralaya (SSDN) base hospital. Despite active outreach in the Boko region from the Boko ECC through conducting regular outreach screenings, less than 30 percent of patients referred to the base hospital actually arrive for evaluation and less than 25 percent of those advised for surgery proceed to treatment. The proposed study addresses these gaps by examining behavioural, structural and logistical barriers to referral completion and surgical uptake, and by implementing a coordinated patient-centered referral and engagement strategy.

The proposed intervention comprises of five sequential components: (1) root cause analysis to identify bottlenecks and facilitators in the current referral pathway, (2) community engagement activities to improve awareness and proactive health-seeking behaviour, (3) implementation of an integrated referral and engagement model supported by trained community team and structured referral tracking, (4) strengthening referral completion through patient navigation, scheduled transport and follow-up reminders, and (5) enhancement of surgical acceptance through standardized counseling, affordability support and social reinforcement. The outcomes will be measured prospectively, focusing on increase in hospital footfall from the Boko catchment area, proportion of referred patients who complete hospital visits, and proportion of patients who were advised for surgery and had undergone the procedure. The proposed project aims to achieve a minimum of 70 percent referral completion and 45 percent surgical conversion by the end of the 36-month study period.

Read the detailed description

This 36-month prospective mixed-methods operational research project is designed to strengthen the referral-to-treatment continuum for rural eye care by improving patient flow from community screening activities at the Boko Eye Care Center (ECC) in Kamrup (Rural), Assam, to Sri Sankaradeva Nethralaya (SSDN) base hospital in Guwahati. Despite extensive outreach activities, the Boko ECC indicated comparatively weak conversion from community identification to hospital attendance and surgical uptake, with recent service statistics indicating less than 30 percent of referred patients reaching the base hospital and less than 25 percent undergoing advised surgery. The gap could be driven by a combination of behavioural barriers (fear, stigma, low motivation, skepticism about surgery), socioeconomic constraints (inability to pay, transport challenges, lost wages), logistical barriers (distance, lack of navigation or follow-up systems), and competition from private providers offering more proactive patient-handling systems. This study aims to systematically identify and address these barriers by developing and evaluating a context-sensitive, patient-centered model that would integrate community engagement, structured patient navigation, standardized counseling and financial facilitation.

The study will be conducted in three phases: a diagnostic research phase, an implementation phase and an evaluation phase. Phase 1 (Months 0-6) would include baseline referral pathway analysis and a root cause analysis using mixed methods. A quantitative baseline data will be extracted from screening registers, referral records and hospital information systems to determine referral uptake and surgical conversion. Qualitative data will be collected through in-depth interviews, focus group discussions, staff consultations and participatory group discussions with patients, family members, outreach field workers, and ECC service providers. The output of this phase will be a synthesized list of bottlenecks and facilitators that will guide intervention refinement.

Phase 2 (Months 7-18) would focus on community engagement and response building. A Community Engagement Toolkit (CET) will be developed and pretested for discussions in local settings and peer influences from successfully treated patients. The Community Eye Health workers and SSDN's dedicated ASECA workers will be trained to reinforce awareness and normalize hospital-based treatment. The engagement activities will be monitored using attendance logs, communication audit checklists and community feedback interviews. A midline survey will be conducted to capture changes in awareness, risk perception and care-seeking behaviour compared to baseline.

Phase 3 (Months 13-36) would focus on implementation of an integrated referral and engagement model informed by findings from Phase 1 and behaviour change momentum from Phase 2. This model would include structured referral tracking at the point of screening, scheduled referral appointments, active follow-up reminders, trained navigators to accompany patients, transport coordination to SSDN and standardized surgical counseling sessions at both the ECC and at the base hospital. The Counseling will follow a documented script that would address disease severity, outcome expectation, fear reduction, cost transparency and postoperative course. The field navigators will maintain referral completion forms and navigation logs. The fidelity of intervention delivery will be supervised through periodic observation and score-based assessment.

The outcome assessment will be done throughout implementation and formally at the end of the study. The primary outcome would be the referral completion rate (defined as the proportion of referred patients attending the SSDN base hospital within 90 days) and the proportionate change in hospital footfall from the Boko catchment area. The secondary outcome would include surgical conversion rate, defined as the percentage of patients advised for surgery who undergo the procedure within 90 days of referral. Trend analyses will also examine whether community engagement contributes to an increase in first-time eye screening attendance. Quantitative analysis will use descriptive statistics, chi-square tests for comparison of proportions, multivariate logistic regression to examine adjusted effects and interrupted time-series analysis to assess change in monthly conversion patterns. Qualitative transcripts will undergo thematic analysis, and the findings will be triangulated with quantitative results to understand mechanisms of change.

The proposed project has both scientific and public health relevance. Scientifically, the project would generate implementation evidence on strengthening referral systems in low-resource settings where passive referrals could lead to bottlenecks in treatment completion. Operationally, it would blend behavioural and structural interventions through toolkits, navigation systems and financial facilitation to reduce preventable blindness. The proposed project is fully aligned with WHO's Integrated People-Centered Eye Care framework and India's National Programme for Control of Blindness and Visual Impairment. Upon completion of the project, the findings are expected to demonstrate feasible and scalable approaches for optimizing patient referral and surgical acceptance in rural Assam, with potential to be adapted across SSDN's network of other 19 primary eye care centers. The expected outcomes include at least 70 percent referral completion, 45 percent surgical conversion and 30 percent rise in hospital footfall from the Boko ECC catchment by the end of 36 months. The broader aim is to establish a durable system of community-to-hospital linkage that would ensure timely access to sight-restoring care for underserved populations.

03

Conditions studied

  • Cataract
  • Refractive Errors

Keywords

  • Referral completion
  • Cataract surgery uptake
  • Patient navigation
  • Community engagement
  • Rural eye care
  • Surgical acceptance
  • Assam
  • LMIC
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Adults diagnosed with eye conditions requiring referral or surgical treatment.

Exclusion criteria

Exclusion Criteria:

Patients requiring emergency treatment, patients medically unfit for surgery, or patients unwilling to participate.

Eligibility: Enrolment criteria: Participants will be enrolled consecutively at the time of screening in community outreach camps and at the Boko Eye Care Center if they meet the following operational criteria:

i. Adult (≥18 years) with a diagnosed eye condition requiring referral to Sri Sankaradeva Nethralaya for tertiary evaluation or surgical treatment, as determined by the examining optometrist/ophthalmologist.

ii. Resident of the Boko Eye Care Center catchment area (villages linked to the Eye Care Center under Sri Sankaradeva Nethralaya outreach).

iii. Patients willing to provide to participate in the study and to allow follow-up for referral completion and surgical acceptance outcomes.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2,000 participants (estimated)

Study arms

  • Experimental
    Referral and Engagement

    Referral tracking, patient navigation, community awareness tools, standardized counseling, transport and financial facilitation mechanisms

    Other: Experimental: Integrated Referral and Engagement Model

Interventions

  • OtherExperimental: Integrated Referral and Engagement Model

    Referral tracking, patient navigation, community awareness tools, standardized counseling, transport and financial facilitation mechanisms

06

What researchers measure

Primary outcomes

  1. Referral completion rate to base hospital

    Referral completion rate to base hospital

    Time frame: 36 months

Secondary outcomes

  1. Surgical conversion rate among patients advised for surgery

    Surgical conversion rate among patients advised for surgery

    Time frame: 36 months

Other outcomes

  1. Increase in overall hospital footfall originating from Boko catchment area

    Increase in overall hospital footfall originating from Boko catchment area

    Time frame: 36 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2026; primary completion for Jan 2027, 7 months later.

Of 300 non-industry interventional studies with no phase under Cataract, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 7 months is below that.

Counting every sponsor, half of 490 studies reached it within 17 months; a quarter within 9 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 30, 2025
First posted
Jan 12, 2026
StartEst.
Jun 15, 2026
Primary completionEst.
Jan 31, 2027
CompletionEst.
Jan 31, 2028
Last update
May 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07333248
Lead sponsor
Seva Canada Society
Collaborators
Pragyaan Sustainable Health Outcomes Foundation, Sri Sankaradeva Nethralaya
Responsible party
Sponsor
First posted
Jan 12, 2026
Start date
Jun 15, 2026 (estimated)
Primary completion
Jan 31, 2027 (estimated)
Completion
Jan 31, 2028 (estimated)
Last update
May 14, 2026

Study contacts

Dr Harsha Bhattacharjee
Contact
ssnghy1@gmail.com
0361-2233444
Priya Adisesha Reddy
study director · Seva Canada Society

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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