Evaluation of TeleOphthalmology in AMD-TeleMedicine Solutions to Improve Patient Access and Quality of Vision Outcomes
This study is currently recruiting participants.
Verified April 2012 by Lawson Health Research Institute
Sponsor:
Lawson Health Research Institute
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
- To evaluate the efficacy of teleophthalmology in screening patients referred to retina specialists for suspected wet AMD.
- 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.
- To determine the efficacy of teleophthalmology in monitoring patients with wet AMD post therapy.
- To determine the compliance rate for monitoring wet AMD during follow-up utilizing teleophthalmology.
- 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.
- To assess patient satisfaction with teleophthalmology versus standard clinical care in the monitoring of post-treatment wet AMD.
- 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:
Genetics Home Reference related topics:
age-related macular degeneration
X-linked juvenile retinoschisis
MedlinePlus related topics:
Macular Degeneration
U.S. FDA Resources
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
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 May 21, 2013