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EFFECT:Eccentric Fixation From Enhanced Clinical Training (EFFECT)

Primary Purpose

Age Related Macular Degeneration (ARMD)

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Supervised Reading
EVT at the PRL
EVT at the TRL
Sponsored by
Moorfields Eye Hospital NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age Related Macular Degeneration (ARMD)

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Moorfields Eye Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Active Comparator

Experimental

Experimental

Arm Label

Group 1-Control

Group 2-Control plus supervised reading

Group 3-EVT at the PRL

Group 4-EVT at the TRL

Arm Description

No extra training will be given.

The same amount of contact time as Groups 3 and 4 - three 45 minute sessions completed over three weeks.

Eccentric viewing training at the Preferred Retinal Locus (PRL), using reading/target cards. Three 45 minute sessions completed over three weeks.

Eccentric viewing training at the Trained Retinal Locus (TRL), using reading/target cards and microperimeter. Three 45 minute sessions completed over three weeks.

Outcomes

Primary Outcome Measures

Score on the Massof Activity Inventory - 6 month follow up

Secondary Outcome Measures

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

Full Information

First Posted
December 20, 2011
Last Updated
September 29, 2016
Sponsor
Moorfields Eye Hospital NHS Foundation Trust
Collaborators
British Eye Research Foundation, operating as Fight for Sight
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1. Study Identification

Unique Protocol Identification Number
NCT01499628
Brief Title
EFFECT:Eccentric Fixation From Enhanced Clinical Training
Acronym
EFFECT
Official Title
Eccentric Fixation From Enhanced Clinical Training (EFFECT): A Randomised Clinical Trial for Patients With AMD
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Moorfields Eye Hospital NHS Foundation Trust
Collaborators
British Eye Research Foundation, operating as Fight for Sight

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Macular Degeneration (ARMD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1-Control
Arm Type
No Intervention
Arm Description
No extra training will be given.
Arm Title
Group 2-Control plus supervised reading
Arm Type
Active Comparator
Arm Description
The same amount of contact time as Groups 3 and 4 - three 45 minute sessions completed over three weeks.
Arm Title
Group 3-EVT at the PRL
Arm Type
Experimental
Arm Description
Eccentric viewing training at the Preferred Retinal Locus (PRL), using reading/target cards. Three 45 minute sessions completed over three weeks.
Arm Title
Group 4-EVT at the TRL
Arm Type
Experimental
Arm Description
Eccentric viewing training at the Trained Retinal Locus (TRL), using reading/target cards and microperimeter. Three 45 minute sessions completed over three weeks.
Intervention Type
Behavioral
Intervention Name(s)
Supervised Reading
Intervention Description
Participant attends once a week for three weeks for a 45 minute appointment of supervised reading using appropriate spectacles and/or glasses
Intervention Type
Behavioral
Intervention Name(s)
EVT at the PRL
Intervention Description
Eccentric viewing training at the Preferred Retinal Locus (PRL), using reading/target cards. Three 45 minute sessions completed over three weeks.
Intervention Type
Behavioral
Intervention Name(s)
EVT at the TRL
Intervention Description
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 Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Reading Speed (ReST) - Final Assessment
Time Frame
Change from Baseline in Reading Speed (ReST) at Final Assessment
Title
Quality of Life (MacDQoL) - Final Assessment
Time Frame
Change from Baseline in Quality of Life (MacDQoL) at Final Assessment
Title
Quality of Life (MacDQoL) - 6 month follow up
Time Frame
Change from Baseline in Quality of Life (MacDQoL) at 6 month follow up
Title
Quality of Life (MacDQoL) - 12 month follow up
Time Frame
Change from Baseline in Quality of Life (MacDQol) at 12 month follow up
Title
Self-reported health status (EQ-5D) - Final Assessment
Time Frame
Change from Baseline in EQ-5D score at Final Assessment
Title
Self-reported health status (EQ-5D) - 6 month follow up
Time Frame
Change from Baseline in EQ-5D score at 6 month follow up
Title
Self-reported health status (EQ-5D) - 12 month follow up
Time Frame
Change from Baseline in EQ-5D score at 12 month follow up
Title
Time Trade Off (TTO) - 6 month follow up
Time Frame
Change from Baseline in Time Trade Off (TTO) score at 6 month follow up
Title
WHO (Five) Well-Being Index (WBI-5) - Final Assessment
Time Frame
Change from Baseline in WBI-5 score at Final Assessment
Title
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
Title
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
Title
Interpersonal Support Evaluation List (ISEL) - Final Assessment
Time Frame
Change from Baseline in Interpersonal Support Evaluation List (ISEL) at Final Assessment
Title
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
Title
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
Title
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
Title
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
Title
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
Title
Massof Activity Inventory - Final Assessment
Time Frame
Change from Baseline in Massof Activity Inventory at Final Assessment
Title
Massof Activity Inventory - 12 month follow up
Time Frame
Change from Baseline in Massof Activity Inventory at 12 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary S Rubin, PhD
Organizational Affiliation
University College, London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moorfields Eye Hospital
City
London
ZIP/Postal Code
EC1V 2PD
Country
United Kingdom

12. IPD Sharing Statement

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EFFECT:Eccentric Fixation From Enhanced Clinical Training

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