NCT07697014

Brief Summary

Although cataract remains the leading cause of avoidable blindness in Nepal, completion of referral from peripheral Eye Care Centers (ECCs) to Bharatpur Eye Hospital (BEH) for cataract surgery remains very low, with only about 3% of referred patients attending the hospital. Poor referral completion is influenced by barriers such as long travel distances, transportation costs, inadequate counselling, fear of surgery, and limited communication between peripheral eye care providers and ophthalmologists. This study aims to evaluate whether an enhanced tele-ophthalmology model improves cataract referral completion compared with the existing referral system. A stratified matched-cluster quasi-experimental study will be conducted in 12 satellite ECCs of Bharatpur Eye Hospital, comprising six intervention ECCs and six matched control ECCs. Adults aged 40 years or older diagnosed with visually significant cataract or other conditions requiring ophthalmological consultation will be enrolled. Participants in intervention ECCs will receive real-time tele-ophthalmology consultation using slit lamp-mounted anterior segment cameras, allowing ophthalmologists to remotely examine patients, confirm the diagnosis, provide counselling, and support referral planning. Control ECCs will continue the existing standard referral process without real-time ophthalmologist-patient interaction. The primary outcome is referral completion, defined as attendance at Bharatpur Eye Hospital or a designated secondary hospital within 12 weeks of referral. Secondary outcomes include patient-reported barriers to referral completion, time to hospital attendance, acceptance of tele-ophthalmology, and diagnostic confidence among ECC staff. A total of 396 participants (198 per group) will be enrolled. Referral completion rates between groups will be compared to determine whether enhanced tele-ophthalmology improves access to cataract surgical services and strengthens referral systems in rural Nepal.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
396

participants targeted

Target at P75+ for not_applicable

Timeline
12mo left

Started Aug 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 10, 2026

Completed
22 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

July 10, 2026

Status Verified

July 1, 2026

Enrollment Period

8 months

First QC Date

July 6, 2026

Last Update Submit

July 6, 2026

Conditions

Keywords

TeleophthalmologyEye care CentreCataract surgeryReferral

Outcome Measures

Primary Outcomes (1)

  • ECC referrals

    The number of referred patients from ECCs through teleconsultation attending base hospital or secondary hospital within the window period of 12weeks±1 weeks.

    3 months

Secondary Outcomes (1)

  • Barriers to referrals

    3 months

Study Arms (2)

Advanced teleophthalmology with referral tracking

EXPERIMENTAL
Other: Advanced teleophthalmology

Existing teleophthalmology

NO INTERVENTION

Interventions

Advanced teleophthalmology that includes real time video consultation with ophthalmologist at base hospital using slit lamp mounted anterior segment camera with referral support and tracking.

Advanced teleophthalmology with referral tracking

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged ≥40 years
  • Diagnosed with visually significant cataract or other ocular conditions requiring Ophthalmological consultation by ECC staff
  • Provided a referral slip to BEH for cataract surgery

You may not qualify if:

  • Patients requiring urgent referral for other ocular comorbidities
  • Patients already under follow-up at BEH
  • Patients unable to participate in tele-consultation due to hearing, communication, or cognitive limitations when companion-assisted consultation is not feasible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2026

First Posted

July 10, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

July 10, 2026

Record last verified: 2026-07