- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07611682
Community-Based Eye Screening With Structured Referral Tracking for Preventing Avoidable Blindness in Adults in Rawalpindi, Pakistan (SIGHT)
Community-Based Eye Screening With a Structured Referral Tracking Intervention for the Prevention of Avoidable Blindness Among Adults in Rawalpindi District, Pakistan
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Avoidable blindness remains a major public health challenge in low- and middle-income countries, including Pakistan. Community-based eye screening camps are commonly used to identify individuals with visual impairment and eye diseases requiring treatment; however, referral completion to tertiary eye care facilities remains poor. Many patients fail to attend referral hospitals because of limited awareness, lack of follow-up, transportation barriers, and uncertainty regarding treatment procedures.
This study aims to evaluate the effectiveness and implementation of a Structured Referral Tracking (SRT) intervention in improving referral completion among adults identified with avoidable blindness during community-based eye screening camps in Rawalpindi District, Pakistan.
The study will use a cluster randomized controlled trial design. Ten community clusters (union councils) from five tehsils of Rawalpindi District will be selected using multistage random sampling. Clusters will be randomized into intervention and control arms. Participants attending eye screening camps who are diagnosed with eye conditions requiring referral to a tertiary eye hospital will be enrolled after informed consent.
Participants in the intervention arm will receive a multi-component Structured Referral Tracking intervention consisting of referral counseling, weekly reminder calls or mobile messages, visual educational material, and customized referral guidance regarding hospital location, estimated costs, and required documents. Participants in the control arm will receive standard referral procedures consisting of routine counseling and referral slips without structured follow-up.
The primary outcome will be referral completion at the tertiary eye hospital within eight weeks after screening, verified through hospital attendance records. Secondary outcomes will include knowledge regarding avoidable blindness, treatment satisfaction, feasibility and acceptability of the intervention, and barriers influencing referral completion.
The findings of this study are expected to provide evidence regarding the effectiveness and feasibility of structured referral tracking systems for improving eye care service utilization and reducing avoidable blindness in Pakistan.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Khizar Nabeel, PHD (In progress)
- Phone Number: +923455096776
- Email: khizar@hsa.edu.pk
Study Locations
-
-
Punjab Province
-
Rawalpindi, Punjab Province, Pakistan, 46600
- ACCO Department, Al-Shifa Trust Eye Hospital, Rawalpindi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 18 years or above
- Individuals diagnosed with visual impairment or eye conditions requiring referral to a tertiary eye care facility
- Permanent residents of Rawalpindi District, Pakistan
- Willing and able to provide informed consent
Exclusion Criteria:
- Individuals already undergoing treatment for the identified eye condition
- Individuals requiring emergency ophthalmic care
- Severe systemic or physical illness limiting follow-up
- Individuals unable to provide informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Structured Referral Tracking (SRT)
Participants will receive structured referral counseling, weekly reminder calls or messages, visual educational material, and customized referral guidance for eight weeks following community-based eye screening.
|
A multi-component referral tracking intervention including referral counseling, weekly reminder calls or mobile messages, visual educational material, and customized referral guidance to improve referral completion after community eye screening.
|
|
No Intervention: Standard Referral Procedure
Participants will receive routine referral slips and standard counseling without structured follow-up or reminder communication.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Referral Completion Rate Verified Through Hospital Records
Time Frame: Within 8 weeks after community eye screening
|
Proportion of referred participants who complete referral visits at the tertiary eye hospital, verified through hospital attendance records.
|
Within 8 weeks after community eye screening
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knowledge Score on Avoidable Blindness Questionnaire
Time Frame: Baseline and 8 weeks after screening
|
Participant knowledge regarding avoidable blindness and eye health assessed using a structured questionnaire developed for the study.
|
Baseline and 8 weeks after screening
|
|
Participant Acceptability of Structured Referral Tracking Assessed Using Structured Feedback Questionnaire
Time Frame: Within 8 weeks after screening
|
Participant acceptability of the Structured Referral Tracking intervention assessed using a structured feedback questionnaire regarding usefulness and satisfaction with reminder communication.
|
Within 8 weeks after screening
|
|
Barriers Influencing Referral Completion Assessed Using Structured Barrier Assessment Questionnaire
Time Frame: Within 8 weeks after screening
|
Barriers and facilitators influencing referral completion assessed using a structured questionnaire among referred participants.
|
Within 8 weeks after screening
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participant Treatment Satisfaction Score Using Structured Satisfaction Questionnaire
Time Frame: Within 8 weeks after screening
|
Participant-reported satisfaction regarding referral services and treatment received at the tertiary eye hospital assessed using a structured satisfaction questionnaire.
|
Within 8 weeks after screening
|
|
Feasibility of Structured Referral Tracking Assessed by Reminder Delivery and Follow-up Completion Rates
Time Frame: Within 8 weeks after screening
|
Feasibility of the intervention assessed through successful delivery of reminder messages/calls and completion of scheduled follow-up procedures.
|
Within 8 weeks after screening
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Dr. Ahmad Abdullah, PHD, Shifa International Hospital, Islamabad
Publications and helpful links
General Publications
- Harwood M, Cunningham W. Lessons from 2020 for equity in global eye health. Lancet Glob Health. 2021 Apr;9(4):e387-e388. doi: 10.1016/S2214-109X(21)00036-X. Epub 2021 Feb 16. No abstract available.
- World Health Organization. Blindness and visual impairment. Geneva: World Health Organization; 2023
- Khan AA, Talpur KI, Awan Z, Arteaga SL, Bolster NM, Katibeh M, Watts E, Bastawrous A. Improving equity, efficiency and adherence to referral in Pakistan's eye health programmes: Pre- and post-pandemic onset. Front Public Health. 2022 Jul 22;10:873192. doi: 10.3389/fpubh.2022.873192. eCollection 2022.
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- hsa2026135
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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