Clinical trial NCT01499628: EFFECT:Eccentric Fixation From Enhanced Clinical Training
Official title: Eccentric Fixation From Enhanced Clinical Training (EFFECT): A Randomised Clinical Trial for Patients With AMD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age Related Macular Degeneration (ARMD)
Lead sponsor: Moorfields Eye Hospital NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: British Eye Research Foundation, operating as Fight for Sight
First posted: 2011-12-26
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Score on the Massof Activity Inventory - 6 month follow up
timeFrame: Change from Baseline in Massof Activity Inventory at 6 month follow up
Secondary outcomes:
measure: Reading Speed (ReST) - Final Assessment
timeFrame: Change from Baseline in Reading Speed (ReST) at Final Assessment
measure: Quality of Life (MacDQoL) - Final Assessment
timeFrame: Change from Baseline in Quality of Life (MacDQoL) at Final Assessment
measure: Quality of Life (MacDQoL) - 6 month follow up
timeFrame: Change from Baseline in Quality of Life (MacDQoL) at 6 month follow up
measure: Quality of Life (MacDQoL) - 12 month follow up
timeFrame: Change from Baseline in Quality of Life (MacDQol) at 12 month follow up
measure: Self-reported health status (EQ-5D) - Final Assessment
timeFrame: Change from Baseline in EQ-5D score at Final Assessment
measure: Self-reported health status (EQ-5D) - 6 month follow up
timeFrame: Change from Baseline in EQ-5D score at 6 month follow up
measure: Self-reported health status (EQ-5D) - 12 month follow up
timeFrame: Change from Baseline in EQ-5D score at 12 month follow up
measure: Time Trade Off (TTO) - 6 month follow up
timeFrame: Change from Baseline in Time Trade Off (TTO) score at 6 month follow up
measure: WHO (Five) Well-Being Index (WBI-5) - Final Assessment
timeFrame: Change from Baseline in WBI-5 score at Final Assessment
measure: WHO (Five) Well-Being Index (WBI-5) - 6 month follow up
timeFrame: Change from Baseline in WBI-5 score at 6 month follow up
measure: WHO (Five) Well-Being Index (WBI-5) - 12 month follow up
timeFrame: Change from Baseline in WBI-5 score at 12 month follow up
measure: Interpersonal Support Evaluation List (ISEL) - Final Assessment
timeFrame: Change from Baseline in Interpersonal Support Evaluation List (ISEL) at Final Assessment
measure: Interpersonal Support Evaluation List (ISEL) - 6 month follow up
timeFrame: Change from Baseline in Interpersonal Support Evaluation List (ISEL) at 6 month follow up
measure: Interpersonal Support Evaluation List (ISEL) - 12 month follow up
timeFrame: Change from Baseline in Interpersonal Support Evaluation List (ISEL) at 12 month follow up
measure: Acceptance and Self Worth Adjustment Scale (AS-WAS) - Final Assessment
timeFrame: Change from Baseline in Acceptance and Self Worth Adjustment Scale (AS-WAS) at Final Assessment
measure: Acceptance and Self Worth Adjustment Scale (AS-WAS) - 6 month follow up
timeFrame: Change from Baseline in Acceptance and Self Worth Adjustment Scale (AS-WAS) at 6 month follow up
measure: Acceptance and Self Worth Adjustment Scale (AS-WAS) - 12 month follow up
timeFrame: Change from Baseline in Acceptance and Self Worth Adjustment Scale (AS-WAS) at 12 month follow up
measure: Massof Activity Inventory - Final Assessment
timeFrame: Change from Baseline in Massof Activity Inventory at Final Assessment
measure: Massof Activity Inventory - 12 month follow up
timeFrame: Change from Baseline in Massof Activity Inventory at 12 month follow up
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Moorfields Eye Hospital
Study officials:
affiliation: University College, London
name: Gary S Rubin, PhD
role: PRINCIPAL_INVESTIGATOR
References: