EFFECT:Eccentric Fixation From Enhanced Clinical Training
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Age Related Macular Degeneration (ARMD) |
Behavioral: Supervised Reading Behavioral: EVT at the PRL Behavioral: EVT at the TRL |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Eccentric Fixation From Enhanced Clinical Training (EFFECT): A Randomised Clinical Trial for Patients With AMD |
- Score on the Massof Activity Inventory - 6 month follow up [ Time Frame: Change from Baseline in Massof Activity Inventory at 6 month follow up ] [ Designated as safety issue: No ]
- Reading Speed (ReST) - Final Assessment [ Time Frame: Change from Baseline in Reading Speed (ReST) at Final Assessment ] [ Designated as safety issue: No ]
- Quality of Life (MacDQoL) - Final Assessment [ Time Frame: Change from Baseline in Quality of Life (MacDQoL) at Final Assessment ] [ Designated as safety issue: No ]
- Quality of Life (MacDQoL) - 6 month follow up [ Time Frame: Change from Baseline in Quality of Life (MacDQoL) at 6 month follow up ] [ Designated as safety issue: No ]
- Quality of Life (MacDQoL) - 12 month follow up [ Time Frame: Change from Baseline in Quality of Life (MacDQol) at 12 month follow up ] [ Designated as safety issue: No ]
- Self-reported health status (EQ-5D) - Final Assessment [ Time Frame: Change from Baseline in EQ-5D score at Final Assessment ] [ Designated as safety issue: No ]
- Self-reported health status (EQ-5D) - 6 month follow up [ Time Frame: Change from Baseline in EQ-5D score at 6 month follow up ] [ Designated as safety issue: No ]
- Self-reported health status (EQ-5D) - 12 month follow up [ Time Frame: Change from Baseline in EQ-5D score at 12 month follow up ] [ Designated as safety issue: No ]
- Time Trade Off (TTO) - 6 month follow up [ Time Frame: Change from Baseline in Time Trade Off (TTO) score at 6 month follow up ] [ Designated as safety issue: No ]
- WHO (Five) Well-Being Index (WBI-5) - Final Assessment [ Time Frame: Change from Baseline in WBI-5 score at Final Assessment ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Interpersonal Support Evaluation List (ISEL) - Final Assessment [ Time Frame: Change from Baseline in Interpersonal Support Evaluation List (ISEL) at Final Assessment ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Massof Activity Inventory - Final Assessment [ Time Frame: Change from Baseline in Massof Activity Inventory at Final Assessment ] [ Designated as safety issue: No ]
- Massof Activity Inventory - 12 month follow up [ Time Frame: Change from Baseline in Massof Activity Inventory at 12 month follow up ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Group 1-Control
No extra training will be given.
|
|
|
Active Comparator: Group 2-Control plus supervised reading
The same amount of contact time as Groups 3 and 4 - three 45 minute sessions completed over three weeks.
|
Behavioral: 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: Group 3-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.
|
Behavioral: 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: Group 4-EVT at the TRL
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
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.
|
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Gary S Rubin, PhD | 02076086989 | g.rubin@ucl.ac.uk |
| Contact: Michael Crossland, PhD | 02076086957 | m.crossland@ucl.ac.uk |
| United Kingdom | |
| Moorfields Eye Hospital | Recruiting |
| London, United Kingdom, EC1V 2PD | |
| Contact: Sue Lydeard 02072533411 sue.lydeard@moorfields.nhs.uk | |
| Principal Investigator: | Gary S Rubin, PhD | University College, London |
More Information
No publications provided
| Responsible Party: | Professor Gary Rubin, Helen Keller Professor of Ophthalmology, University College, London |
| ClinicalTrials.gov Identifier: | NCT01499628 History of Changes |
| Other Study ID Numbers: | RUBG1008, Fight for Sight Ref: 1777/78 |
| Study First Received: | December 20, 2011 |
| Last Updated: | December 22, 2011 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Additional relevant MeSH terms:
|
Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases |
ClinicalTrials.gov processed this record on June 17, 2013