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EFFECT:Eccentric Fixation From Enhanced Clinical Training

NCT ID: NCT01499628

Last Updated: 2023-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-27

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Age Related Macular Degeneration (ARMD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group 1-Control

No extra training will be given.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

Supervised Reading

Intervention Type BEHAVIORAL

Participant attends once a week for three weeks for a 45 minute appointment of supervised reading using appropriate spectacles and/or glasses

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.

Group Type EXPERIMENTAL

EVT at the PRL

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

EVT at the TRL

Intervention Type BEHAVIORAL

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.

Interventions

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Supervised Reading

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

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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British Eye Research Foundation, operating as Fight for Sight

UNKNOWN

Sponsor Role collaborator

Moorfields Eye Hospital NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gary S Rubin, PhD

Role: PRINCIPAL_INVESTIGATOR

University College, London

Locations

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Moorfields Eye Hospital

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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Fight for Sight Ref: 1777/78

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

RUBG1008

Identifier Type: -

Identifier Source: org_study_id