EFFECT:Eccentric Fixation From Enhanced Clinical Training

Study Overview
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Brief Summary
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Age-related macular degeneration (AMD) is the leading cause of severe visual impairment in the UK, Europe and N America. Low vision patients with AMD have great difficulty reading, which leads to a loss of independence and reduced quality of life. Magnifiers alone do not compensate for loss of central vision in AMD. It has been proposed that special low vision training can improve reading ability in patients with AMD. Training programmes are widely available in the US and Scandinavia, but not in the UK, partly because there is a lack of evidence from Randomised Control Trials (RCT) showing that they are effective. The investigators are conducting a clinical trial comparing the conventional hospital-based low vision service to enhanced rehabilitation programmes that include Eccentric Viewing training. Eccentric viewing training involves teaching patients who have lost their central vision to use a new area of retina for visual tasks. Patients are either taught to improve the use of the part of the retina they naturally start using after their central vision is lost, their so-called preferred retinal locus (PRL), or, alternatively, they are taught to use a different retinal area that is thought to be better suited for everyday visual tasks, the so-called trained retinal locus (TRL). The investigators plan to compare the two types of eccentric viewing training to conventional hospital-based low vision care.

Official Title
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Eccentric Fixation From Enhanced Clinical Training (EFFECT): A Randomised Clinical Trial for Patients With AMD

Conditions
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Age Related Macular Degeneration (ARMD)

Intervention / Treatment
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* Behavioral: Supervised Reading
* Behavioral: EVT at the PRL
* Behavioral: EVT at the TRL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of age-related macular degeneration Visual acuity 6/12 to 3/60 inclusive in the better eye Dense central scotoma confirmed by microperimetry Exclusion Criteria: Patients who are not fluent in English or are cognitively impaired Patients with serious hearing impairment Patients who are hospital inpatients, who are living in nursing homes or are otherwise non-independent Ocular co-morbidity (other than mild cataract) in the better eye Recent low vision assessment or eccentric viewing training

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group 1-Control<br>No extra training will be given. | |
| Active Comparator: Group 2-Control plus supervised reading<br>The same amount of contact time as Groups 3 and 4 - three 45 minute sessions completed over three weeks. | Behavioral: Supervised Reading<br>* Participant attends once a week for three weeks for a 45 minute appointment of supervised reading using appropriate spectacles and/or glasses<br>|
| Experimental: Group 3-EVT at the PRL<br>Eccentric viewing training at the Preferred Retinal Locus (PRL), using reading/target cards. Three 45 minute sessions completed over three weeks. | Behavioral: EVT at the PRL<br>* Eccentric viewing training at the Preferred Retinal Locus (PRL), using reading/target cards. Three 45 minute sessions completed over three weeks.<br>|
| Experimental: Group 4-EVT at the TRL<br>Eccentric viewing training at the Trained Retinal Locus (TRL), using reading/target cards and microperimeter. Three 45 minute sessions completed over three weeks. | Behavioral: EVT at the TRL<br>* Participant attends once a week for three weeks for a 45 minute appointment of TRL training using the MAIA microperimeter and then further reading using magnifiers and/or spectacles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score on the Massof Activity Inventory - 6 month follow up |  | Change from Baseline in Massof Activity Inventory at 6 month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reading Speed (ReST) - Final Assessment |  | Change from Baseline in Reading Speed (ReST) at Final Assessment | 
| Quality of Life (MacDQoL) - Final Assessment |  | Change from Baseline in Quality of Life (MacDQoL) at Final Assessment | 
| Quality of Life (MacDQoL) - 6 month follow up |  | Change from Baseline in Quality of Life (MacDQoL) at 6 month follow up | 
| Quality of Life (MacDQoL) - 12 month follow up |  | Change from Baseline in Quality of Life (MacDQol) at 12 month follow up | 
| Self-reported health status (EQ-5D) - Final Assessment |  | Change from Baseline in EQ-5D score at Final Assessment | 
| Self-reported health status (EQ-5D) - 6 month follow up |  | Change from Baseline in EQ-5D score at 6 month follow up | 
| Self-reported health status (EQ-5D) - 12 month follow up |  | Change from Baseline in EQ-5D score at 12 month follow up | 
| Time Trade Off (TTO) - 6 month follow up |  | Change from Baseline in Time Trade Off (TTO) score at 6 month follow up | 
| WHO (Five) Well-Being Index (WBI-5) - Final Assessment |  | Change from Baseline in WBI-5 score at Final Assessment | 
| WHO (Five) Well-Being Index (WBI-5) - 6 month follow up |  | Change from Baseline in WBI-5 score at 6 month follow up | 
| WHO (Five) Well-Being Index (WBI-5) - 12 month follow up |  | Change from Baseline in WBI-5 score at 12 month follow up | 
| Interpersonal Support Evaluation List (ISEL) - Final Assessment |  | Change from Baseline in Interpersonal Support Evaluation List (ISEL) at Final Assessment | 
| Interpersonal Support Evaluation List (ISEL) - 6 month follow up |  | Change from Baseline in Interpersonal Support Evaluation List (ISEL) at 6 month follow up | 
| Interpersonal Support Evaluation List (ISEL) - 12 month follow up |  | Change from Baseline in Interpersonal Support Evaluation List (ISEL) at 12 month follow up | 
| Acceptance and Self Worth Adjustment Scale (AS-WAS) - Final Assessment |  | Change from Baseline in Acceptance and Self Worth Adjustment Scale (AS-WAS) at Final Assessment | 
| Acceptance and Self Worth Adjustment Scale (AS-WAS) - 6 month follow up |  | Change from Baseline in Acceptance and Self Worth Adjustment Scale (AS-WAS) at 6 month follow up | 
| Acceptance and Self Worth Adjustment Scale (AS-WAS) - 12 month follow up |  | Change from Baseline in Acceptance and Self Worth Adjustment Scale (AS-WAS) at 12 month follow up | 
| Massof Activity Inventory - Final Assessment |  | Change from Baseline in Massof Activity Inventory at Final Assessment | 
| Massof Activity Inventory - 12 month follow up |  | Change from Baseline in Massof Activity Inventory at 12 month follow up |