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EFFECT:Eccentric Fixation From Enhanced Clinical Training (EFFECT)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01499628
First Posted: December 26, 2011
Last Update Posted: September 30, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
British Eye Research Foundation, operating as Fight for Sight
Information provided by (Responsible Party):
Professor Gary Rubin, University College, London
  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
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Eccentric Fixation From Enhanced Clinical Training (EFFECT): A Randomised Clinical Trial for Patients With AMD

Resource links provided by NLM:


Further study details as provided by Professor Gary Rubin, University College, London:

Primary Outcome Measures:
  • 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 Measures:
  • Reading Speed (ReST) - Final Assessment [ Time Frame: 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 ]
  • Quality of Life (MacDQoL) - 6 month follow up [ Time Frame: 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 ]
  • Self-reported health status (EQ-5D) - Final Assessment [ Time Frame: 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 ]
  • Self-reported health status (EQ-5D) - 12 month follow up [ Time Frame: 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 ]
  • WHO (Five) Well-Being Index (WBI-5) - Final Assessment [ Time Frame: 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 ]
  • 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 ]
  • Interpersonal Support Evaluation List (ISEL) - Final Assessment [ Time Frame: 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Massof Activity Inventory - Final Assessment [ Time Frame: 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 ]

Estimated Enrollment: 200
Study Start Date: April 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: April 2017 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01499628


Locations
United Kingdom
Moorfields Eye Hospital
London, United Kingdom, EC1V 2PD
Sponsors and Collaborators
Moorfields Eye Hospital NHS Foundation Trust
British Eye Research Foundation, operating as Fight for Sight
Investigators
Principal Investigator: Gary S Rubin, PhD University College, London
  More Information

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 ( Other Grant/Funding Number: Funder )
First Submitted: December 20, 2011
First Posted: December 26, 2011
Last Update Posted: September 30, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases