Evaluation of TeleOphthalmology in Age-related Macular Degeneration (AMD) - TeleMedicine Solutions to Improve Patient Access and Quality of Vision Outcomes.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 169
- 试验地点
- 1
- 主要终点
- Wait time for treatment (naive versus follow-up patients).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Wait time for treatment (naive versus follow-up patients).
时间窗: One month for Tele-screening evaluation in both groups.
次要结局
- Patient satisfaction.(One month.)