Overview

This trial is active, not recruiting.

Condition age related macular degeneration (armd)
Treatments supervised reading, evt at the prl, evt at the trl
Sponsor Moorfields Eye Hospital NHS Foundation Trust
Collaborator British Eye Research Foundation, operating as Fight for Sight
Start date April 2011
End date April 2017
Trial size 200 participants
Trial identifier NCT01499628, Fight for Sight Ref: 1777/78, RUBG1008

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(No Intervention)
No extra training will be given.
(Active Comparator)
The same amount of contact time as Groups 3 and 4 - three 45 minute sessions completed over three weeks.
supervised reading
Participant attends once a week for three weeks for a 45 minute appointment of supervised reading using appropriate spectacles and/or glasses
(Experimental)
Eccentric viewing training at the Preferred Retinal Locus (PRL), using reading/target cards. Three 45 minute sessions completed over three weeks.
evt at the prl
Eccentric viewing training at the Preferred Retinal Locus (PRL), using reading/target cards. Three 45 minute sessions completed over three weeks.
(Experimental)
Eccentric viewing training at the Trained Retinal Locus (TRL), using reading/target cards and microperimeter. Three 45 minute sessions completed over three weeks.
evt at the trl
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.

Primary Outcomes

Measure
Score on the Massof Activity Inventory - 6 month follow up
time frame: Change from Baseline in Massof Activity Inventory at 6 month follow up

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 50 years old.

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

Additional Information

Official title Eccentric Fixation From Enhanced Clinical Training (EFFECT): A Randomised Clinical Trial for Patients With AMD
Principal investigator Gary S Rubin, PhD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Moorfields Eye Hospital NHS Foundation Trust.