EFFECT:Eccentric Fixation From Enhanced Clinical Training (EFFECT)

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

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.

Study Overview

• Status: Completed
• Conditions: Age Related Macular Degeneration (ARMD)
• Intervention / Treatment: Behavioral: Supervised Reading; Behavioral: EVT at the PRL; Behavioral: EVT at the TRL

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, EC1V 2PD
    • Moorfields Eye Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Moorfields Eye Hospital NHS Foundation Trust
• Collaborators: British Eye Research Foundation, operating as Fight for Sight
• Investigators: Principal Investigator: Gary S Rubin, PhD, University College, London

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2011
• Primary Completion (Actual): November 26, 2015
• Study Completion (Actual): December 31, 2015

Study Registration Dates

• First Submitted: December 20, 2011
• First Submitted That Met QC Criteria: December 22, 2011
• First Posted (Estimated): December 26, 2011

Study Record Updates

• Last Update Posted (Actual): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: RUBG1008; Fight for Sight Ref: 1777/78 (Other Grant/Funding Number: Funder)