NCT07184255

Brief Summary

Retinal detachment is a vision-threatening condition that requires urgent surgical repair. Understanding the condition, the surgery, and post-operative instructions is difficult for many patients, particularly in multilingual and multicultural populations. This study will evaluate whether short, animated educational videos, available in 25 languages and designed with accessibility features for patients with low vision, improve patient knowledge, reduce anxiety, and support adherence to post-operative instructions when added to standard counselling. Patients will be randomized to standard counselling alone versus counselling plus video in their preferred language. Outcomes will be measured with validated questionnaires at baseline, immediately after counselling, and one week post-surgery.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

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

Study Progress35%
Jan 2026Dec 2026

First Submitted

Initial submission to the registry

September 13, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

6 months

First QC Date

September 13, 2025

Last Update Submit

September 13, 2025

Conditions

Retinal Detachment

Keywords

Retinal DetachmentPatient EducationMultilingual Video InterventionHealth LiteracyEye surgeryKnowledge translation

Outcome Measures

Primary Outcomes (1)

  • Knowledge

    Change in knowledge score (0-10 scale) from baseline (pre-surgery) to post-intervention and procedure.

    1 week

Secondary Outcomes (4)

  • Anxiety

    1 week

  • Understanding

    1 week

  • Adherence

    1 week

  • Patient Satisfaction

    1 week

Study Arms (2)

Control Arm (Standard Counselling)

NO INTERVENTION

Standard pre-operative verbal counselling by ophthalmologist/clinic staff.

Intervention Arm (Video + Standard Counselling)

EXPERIMENTAL

Standard counselling plus a 5-minute animated video in the patient's preferred language, covering diagnosis, surgical steps, and post-operative positioning. Video includes high-contrast visuals and audio narration.

Other: Patient Education Video Intervention

Interventions

Patient Education Video InterventionOTHER

Animated video with high-contrast visuals and audio narration in the patient's preferred language, covering diagnosis, surgical steps, and post-operative positioning.

Intervention Arm (Video + Standard Counselling)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adults ≥18 years.
  • Diagnosis of primary rhegmatogenous retinal detachment.
  • Planned repair with pneumatic retinopexy (PnR), pars plana vitrectomy (PPV), or scleral buckle (SB).
  • Able to provide informed consent.
  • Preferred language available among study videos.

You may not qualify if:

  • Repeat retinal detachment surgery in study eye.
  • Combined complex procedures (e.g., PPV + corneal transplant).
  • Severe cognitive impairment precluding consent.
  • Hearing impairment preventing use of audio track (without aid).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network, Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

MeSH Terms

Conditions

Retinal Detachment

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Central Study Contacts

Tina Felfeli, MD, PhD

CONTACT

(416) 603-5418tina.felfeli@mail.utoronto.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Parallel Assignment, 1:1 randomization, stratified by surgical procedure (PnR, PPV, SB) and language proficiency (English vs non-English).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

September 13, 2025

First Posted

September 19, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

September 19, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

Yes. De-identified individual-level data (survey responses, knowledge scores, anxiety scales) will be shared via institutional repositories upon reasonable request, following UHN REB approval.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Within 12 months of publication.

Locations

CA(1)