Evaluation of TeleOphthalmology in AMD-TeleMedicine Solutions to Improve Patient Access and Quality of Vision Outcomes

NCT01581606 | Completed

• 1 other identifier: 18045E
• Study Type: observational
• Target: 169
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothesis: The use of teleophthalmology for patient screening will result in more rapid patient access for treatment. The use of teleophthalmology to monitor patients with wet AMD post-treatment will result in maintenance of good visual outcomes combined with a reduction in patient travel and improved patients satisfaction in a cost effective manner. Objectives : The Evaluation of Teleophthalmology in AMD project objectives are as follows:

1. 1.To evaluate the efficacy of teleophthalmology in screening patients referred to retina specialists for suspected wet AMD.
2. 2.To compare the "time to treatment/retreatment" with this program with that of patient's entering the system and being followed conventionally to determine the efficacy of teleophthalmology to provide rapid entry/re-entry into treatment programs.
3. 3.To determine the efficacy of teleophthalmology in monitoring patients with wet AMD post therapy.
4. 4.To determine the compliance rate for monitoring wet AMD during follow-up utilizing teleophthalmology.
5. 5.To evaluate the cost effectiveness of teleophthalmology in screening/monitoring wet AMD patients including direct costs to the OHIP system and indirect costs to the patient/caregiver.
6. 6.To assess patient satisfaction with teleophthalmology versus standard clinical care in the monitoring of post-treatment wet AMD.
7. 7.To evaluate teleophthalmology as a tool for communication between community based Optometrists /Ophthalmologists and Retina Specialists.

Conditions

Age Related Macular Degeneration

Keywords

Age Related Macular Degeneration; Teleophthalmology; Screening; Diagnosis; Timing; Treatment

Outcome Measures

Primary Outcomes (1)

• Wait time for treatment (naive versus follow-up patients).

  One month for Tele-screening evaluation in both groups.

Secondary Outcomes (1)

• Patient satisfaction.

  One month.

Study Arms (2)

Group 1R and 1T AMD Screening

Group 1 patients will be collected through all referrals to any of the physician investigators with a provisional diagnosis of possible wet AMD. Any request for clinical evaluation of a patient for presumed wet AMD will be randomized into Group 1R (Routine Screening) and Group 1T (Tele-ophthalmology screening).

Group 2R and 2T Follow up

Group 2 patients will be collected from the patients previously treated for wet AMD within the practices of the physician investigators. All patients in whom the disease is inactive (not receiving active treatment) and who therefore require monitoring will be randomized into Group 2R (Routine Monitoring) and Group 2T (Teleophthalmology Monitoring).

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Group 1: Patients will be collected from all referrals with a provisional diagnosis of possible Wet-AMD to any of the physician investigators. Group 2: Subjects will be collected from patients previously treated at this institution for wet-AMD within the practices of the physician investigators.

You may qualify if:

• Group 1: Patients will be collected from all referrals with a provisional diagnosis of possible Wet-AMD to any of the physician investigators. These patients will subsequently be randomized into Group 1R (Routine Screening) and Group 1T (Tele-ophthalmology Screening)
• Group 2: Patients will be collected from patients previously treated at this institution for Wet-AMD within the practices of the physician investigators. All patients in whom the disease is inactive (not receiving active treatment) and who require monitoring will be randomized into Group 2R (Routine Monitoring) and Group 2T (Tele-Ophthalmology Monitoring).

You may not qualify if:

• Patients will be excluded if they live more than an hours driving distance from London or from one of the afore-mentioned Ocular Health Centre(s)
• Patients with a presumed diagnosis of Wet-AMD at the time of referral who have previously had diagnostic imaging performed as part of the referral will be excluded.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• The Physicians' Services Incorporated Foundation: collaborator
• Academic Health Science Centres: collaborator

Study Sites (1)

Ivey Eye Institute, St. Joseph's Health Care

London, Ontario, N6A 4V2, Canada

Location

Related Publications (1)

• Li B, Powell AM, Hooper PL, Sheidow TG. Prospective evaluation of teleophthalmology in screening and recurrence monitoring of neovascular age-related macular degeneration: a randomized clinical trial. JAMA Ophthalmol. 2015 Mar;133(3):276-82. doi: 10.1001/jamaophthalmol.2014.5014.

  PMID: 25473945 DERIVED

MeSH Terms

Conditions

Macular Degeneration; Disease

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas G Sheidow, MD, FRCSC

  Ivey Eye Institute, St. Joseph's Health Care, London, Ontario, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2012
• First Posted: April 20, 2012
• Study Start: April 30, 2013
• Primary Completion: April 4, 2014
• Study Completion: April 7, 2014
• Last Updated: November 6, 2017

Record last verified: 2017-11

Locations

CA (1)