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Age Related Macular DegenerationNCT01581606

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

An observational study of Age Related Macular Degeneration, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Age Related Macular Degeneration
How many people
169 participants
Where
1 siteCanada
Study dates
30 Apr 2013to 7 Apr 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Ivey Eye Institute, St. Joseph's Health Care

    London, Ontario, N6A 4V2

Other trials in Canada

About this study

Official title: Evaluation of TeleOphthalmology in Age-related Macular Degeneration (AMD) - TeleMedicine Solutions to Improve Patient Access and Quality of Vision Outcomes.

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.

Read more

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.
Read the detailed description

For purposes of this study, two patient streams will be developed and implemented: AMD screening patients (Group 1) and post-Lucentis monitoring patients (Group 2).

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).

In group 1R patients will receive an appointment in the current standard fashion with review and consultation within the retinal physician's office, evaluation of the need for diagnostic testing and subsequent treatment as indicated. Group 1T will undergo pre-screening at the nearest OHC. These patients will obtain full ocular evaluation by the current OTN (Ontario Telemedicine Network) ophthalmology pilot standards (visual acuity, intraocular pressure measurement, fundus photography and OCT - at a quality level established by a working group for the OTN in 2009). At the completion of the screening visit, images and data will be stored in the OHC database and notification of the visit sent to the treating center. This will trigger a formal evaluation and grading of the patient's status and determination of the need for an in person evaluation and treatment at the treating center. This formal evaluation will occur only if the teleophthalmology dataset suggests the presence of wet AMD requiring treatment or if the dataset quality is insufficient to allow accurate determination of the need to treat. In both groups following consultation, a full report for each patient will be generated which documents the patient's current macular status and suggested management strategy.

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).

As in group 1, patients in Group 2T will obtain a full ocular evaluation by the current OTN (Ontario Telemedicine Network) ophthalmology pilot standards, and as in group 1, this data will be analyzed to determine the need for retreatment. If necessary, the patients will be recalled to the treating center. Those who do not meet the requirements for retreatment will be booked for reassessment in two months. The two month follow up period, although longer than the "gold standard", is the routine being employed clinically at this time across the province. This is due to the current OHIP rules which cover the costs associated with OCT to a maximum of 6 per year and a desire to limit the out of pocket expenses patients incur. The follow up period of two months will be standard in both groups 2T and 2R.

Group 2R patients will be reviewed in person with evaluation in the standard fashion by obtaining visual acuity, fundus photography and OCT within the investigators clinic and will receive treatment following this consultation as needed on the date of that visit.

Data will be collected, stored, and transmitted in a secure password protected manner with appropriate encryption.

Data to be obtained will include participant age, sex, number and type of prior AMD treatments, current driving status, distance from the site of residence to the screening and treatment sites respectively. Data to answer objective 2 will be obtained by the research coordinator at study entry including duration of visual symptoms, time (in weeks) from initiation of symptoms to initial assessment visit and time (in weeks) between initial assessment and screening visit to determine treatment eligibility), time from monitoring visit to treatment, and the number of visits not requiring treatment (deemed "avoidable"). The study will included a short, post screening visit patient satisfaction questionnaire to assess the perceived patient satisfaction with the screening/monitoring process to answer objective 6. In patients who are being followed after treatment, additional demographics from the office of the vitreoretinal surgeons will be collected including baseline visual acuity, and prior treatments (in each eye and number of treatments).

Data will be collected to document patient compliance with scheduled visits, the timing of evaluations, the imaging quality/adequacy as perceived by the grading physician, recurrent disease activity and recurrence rate, and time from the assessment visits treatment if applicable. Patients will also be administered a short patient satisfaction survey regarding duration of visit, parking / facility access, perceived satisfaction with clinic or OHC visit. These questionnaires will be done at discharge from the hospital system, at the completion of the first OHC visit and at the end of 1 year of follow up.

Keywords
Age Related Macular Degeneration, Teleophthalmology, Screening, Diagnosis, Timing, Treatment
Medical subject headings
Macular Degeneration, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01581606
Study groupRoleWhat they receive
Group 1R and 1T AMD ScreeningGroup 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 upGroup 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: One month for Tele-screening evaluation in both groups.

Secondary outcomes (1)
  1. Patient satisfaction.

    Measured: One month.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2012 (estimated)
  2. Study start30 Apr 2013
  3. Primary completion4 Apr 2014
  4. Study completion7 Apr 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
169 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01581606
Sponsor's protocol ID
18045E
Status last verified
Nov 2017
First submitted
12 Apr 2012
Last updated
6 Nov 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 25473945

Questions about this trial

What is this clinical trial studying?

An observational study of Age Related Macular Degeneration, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Wait time for treatment (naive versus follow-up patients). (time frame: One month for Tele-screening evaluation in both groups.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01581606, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.

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