NCT01899963

Brief Summary

In this province, optometrists are often responsible for contacting the retinal specialists' office to arrange patients to be examined for suspected emergencies or more routine referrals related to the eye. This is often done by faxing a referral form to the specialists' office, where the retinal specialist will examine the information presented in the referral form and make a decision on when the patient should be seen. This current method has some important considerations, such as the difficulty of transmitting clear images of the back of the eye over fax. Having this information could help the retinal specialist in determining when the patient should be seen, especially in terms of booking additional tests or when treatment should be given. Teleophthalmology is a branch of telemedicine that delivers eye care through digital equipment and telecommunications technology. It offers some unique advantages, such as the ability to be integrated with electronic health records, the ability to be viewed by multiple members of the health care team, and potentially reduce wait times and travel times to the ophthalmologist. However, there is no comparison known to the study team between whether patients being referred from optometrists to retina specialists through a teleophthalmology system will be treated earlier than patients through a conventional fax system. This study aims to examine and provide more information on this topic.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
83

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 16, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

May 22, 2023

Status Verified

May 1, 2023

Enrollment Period

8.2 years

First QC Date

July 9, 2013

Last Update Submit

May 19, 2023

Conditions

Keywords

wet Age Related Macular DegenerationDiabetic Macular EdemaTelemedicineTeleophthalmologyTime to Treatment

Outcome Measures

Primary Outcomes (1)

  • Time to Treatment

    Defined as defined as the time between when the retina specialist reviews the information collected by either system to when the patient receives treatment by the specialist in the clinic.

    Average 5-6 Weeks.

Secondary Outcomes (5)

  • Maximum wait time

    Can range from 2-6 weeks.

  • Minimum Wait Time

    Can range from 2-6 weeks.

  • Mean wait time

    Can range from 2-6 weeks.

  • Travel time

    Can range from 30 minutes or greater.

  • Travel Distance

    Can range from 1 kilometer or greater.

Study Arms (2)

Tele-ophthalmology Referral Group

This group includes patients referred to a retinal specialist via a teleophthalmology referral system.

Conventional Referral Group

This group includes patients referred to a retinal specialist via a conventional fax system.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population includes patients who are referred from an optometrist either participating in the teleophthalmology referral system or via conventional fax referrals with a provisional diagnosis of possible wet AMD or DME to any of the physician investigators.

You may qualify if:

  • Aged greater than 18 years,
  • Able to provide informed consent,
  • Referred from an optometrist either participating in the teleophthalmology referral system or via conventional fax referrals with a provisional diagnosis of possible wet AMD or DME to any of the physician investigators.

You may not qualify if:

  • Patients with a presumed diagnosis of wet AMD and/or DME at the time of referral who previously had diagnostic imaging (ex. fundus images, OCT images) performed as part of the referral will be excluded;
  • Patients unable to tolerate fluorescein angiography (FA);
  • Patients unable to travel to the retina practice for treatment or further testing,
  • Patients unable to fully understand the study requirements and provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph's Healthcare Hamilton King Campus

Hamilton, Ontario, L8G5E4, Canada

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2013

First Posted

July 16, 2013

Study Start

November 1, 2013

Primary Completion

January 1, 2022

Study Completion

February 1, 2022

Last Updated

May 22, 2023

Record last verified: 2023-05

Locations