EFFECT:Eccentric Fixation From Enhanced Clinical Training (EFFECT)

December 1, 2023 updated by: Moorfields Eye Hospital NHS Foundation Trust

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Score on the Massof Activity Inventory - 6 month follow up
Time Frame: Change from Baseline in Massof Activity Inventory at 6 month follow up
Change from Baseline in Massof Activity Inventory at 6 month follow up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Reading Speed (ReST) - Final Assessment
Time Frame: Change from Baseline in Reading Speed (ReST) at Final Assessment
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Change from Baseline in Massof Activity Inventory at 12 month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Moorfields Eye Hospital NHS Foundation Trust

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
British Eye Research Foundation, operating as Fight for Sight

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gary S Rubin, PhD, University College, London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 27, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 26, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 20, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2011

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 26, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RUBG1008
  • Fight for Sight Ref: 1777/78 (Other Grant/Funding Number: Funder)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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