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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Lawson Health Research Institute.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
The Physicians' Services Incorporated Foundation
Alternate Funding Plans for Academic Health Sciences Centres
Information provided by (Responsible Party):
Thomas G. Sheidow, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01581606
First received: April 12, 2012
Last updated: April 18, 2012
Last verified: April 2012
  Purpose

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. To evaluate the efficacy of teleophthalmology in screening patients referred to retina specialists for suspected wet AMD.
  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. To determine the efficacy of teleophthalmology in monitoring patients with wet AMD post therapy.
  4. To determine the compliance rate for monitoring wet AMD during follow-up utilizing teleophthalmology.
  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. To assess patient satisfaction with teleophthalmology versus standard clinical care in the monitoring of post-treatment wet AMD.
  7. To evaluate teleophthalmology as a tool for communication between community based Optometrists /Ophthalmologists and Retina Specialists.

Condition
Age Related Macular Degeneration

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of TeleOphthalmology in Age-related Macular Degeneration (AMD) - TeleMedicine Solutions to Improve Patient Access and Quality of Vision Outcomes.

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Wait time for treatment (naive versus follow-up patients). [ Time Frame: One month for Tele-screening evaluation in both groups. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient satisfaction. [ Time Frame: One month. ] [ Designated as safety issue: No ]

Estimated Enrollment: 212
Study Start Date: November 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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).

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01581606

Contacts
Contact: Thomas G Sheidow, MD, FRCSC 519.685.8133 tom.sheidow@lhsc.on.ca
Contact: Anne-Marie Powell, RN 519.685.8500 ext 52606 annemarie.powell@sjhc.london.on.ca

Locations
Canada, Ontario
Ivey Eye Institute, St. Joseph's Health Care Recruiting
London, Ontario, Canada, N6A 4V2
Contact: Thomas G Sheidow, MD, FRCSC    519.685.8133    tom.sheidow@lhsc.on.ca   
Contact: Anne-Marie Powell, RN    519.685.8500 ext 52606    annemarie.powell@sjhc.london.on.ca   
Principal Investigator: Thomas G Sheidow, MD, FRCSC         
Sub-Investigator: Philip L Hooper, MD, FRCSC         
Sponsors and Collaborators
Lawson Health Research Institute
The Physicians' Services Incorporated Foundation
Alternate Funding Plans for Academic Health Sciences Centres
Investigators
Principal Investigator: Thomas G Sheidow, MD, FRCSC Ivey Eye Institute, St. Joseph's Health Care, London, Ontario, Canada
  More Information

No publications provided

Responsible Party: Thomas G. Sheidow, Ophthalmologist, Vitreoretinal Surgeon, Associate Professor of Ophthalmology, University of Western Ontario, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01581606     History of Changes
Other Study ID Numbers: 18045E
Study First Received: April 12, 2012
Last Updated: April 18, 2012
Health Authority: Canada: Health Canada

Keywords provided by Lawson Health Research Institute:
Age Related Macular Degeneration
Teleophthalmology
Screening
Diagnosis
Timing
Treatment

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on September 16, 2014