EFFECT:Eccentric Fixation From Enhanced Clinical Training

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2011 by Moorfields Eye Hospital NHS Foundation Trust
Sponsor:
Collaborator:
British Eye Research Foundation, operating as Fight for Sight
Information provided by (Responsible Party):
Professor Gary Rubin, University College, London
ClinicalTrials.gov Identifier:
NCT01499628
First received: December 20, 2011
Last updated: December 22, 2011
Last verified: December 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 Moorfields Eye Hospital NHS Foundation Trust:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reading Speed (ReST) - Final Assessment [ Time Frame: Change from Baseline in Reading Speed (ReST) at Final Assessment ] [ Designated as safety issue: No ]
  • Quality of Life (MacDQoL) - Final Assessment [ Time Frame: Change from Baseline in Quality of Life (MacDQoL) at Final Assessment ] [ Designated as safety issue: No ]
  • Quality of Life (MacDQoL) - 6 month follow up [ Time Frame: Change from Baseline in Quality of Life (MacDQoL) at 6 month follow up ] [ Designated as safety issue: No ]
  • Quality of Life (MacDQoL) - 12 month follow up [ Time Frame: Change from Baseline in Quality of Life (MacDQol) at 12 month follow up ] [ Designated as safety issue: No ]
  • Self-reported health status (EQ-5D) - Final Assessment [ Time Frame: Change from Baseline in EQ-5D score at Final Assessment ] [ Designated as safety issue: No ]
  • Self-reported health status (EQ-5D) - 6 month follow up [ Time Frame: Change from Baseline in EQ-5D score at 6 month follow up ] [ Designated as safety issue: No ]
  • Self-reported health status (EQ-5D) - 12 month follow up [ Time Frame: Change from Baseline in EQ-5D score at 12 month follow up ] [ Designated as safety issue: No ]
  • Time Trade Off (TTO) - 6 month follow up [ Time Frame: Change from Baseline in Time Trade Off (TTO) score at 6 month follow up ] [ Designated as safety issue: No ]
  • WHO (Five) Well-Being Index (WBI-5) - Final Assessment [ Time Frame: Change from Baseline in WBI-5 score at Final Assessment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Interpersonal Support Evaluation List (ISEL) - Final Assessment [ Time Frame: Change from Baseline in Interpersonal Support Evaluation List (ISEL) at Final Assessment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Massof Activity Inventory - Final Assessment [ Time Frame: Change from Baseline in Massof Activity Inventory at Final Assessment ] [ Designated as safety issue: No ]
  • Massof Activity Inventory - 12 month follow up [ Time Frame: Change from Baseline in Massof Activity Inventory at 12 month follow up ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: April 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01499628

Contacts
Contact: Gary S Rubin, PhD 02076086989 g.rubin@ucl.ac.uk
Contact: Michael Crossland, PhD 02076086957 m.crossland@ucl.ac.uk

Locations
United Kingdom
Moorfields Eye Hospital Recruiting
London, United Kingdom, EC1V 2PD
Contact: Sue Lydeard    02072533411    sue.lydeard@moorfields.nhs.uk   
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

No publications provided

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
Study First Received: December 20, 2011
Last Updated: December 22, 2011
Health Authority: United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on August 27, 2014