EFFECT:Eccentric Fixation From Enhanced Clinical Training

Age Related Macular Degeneration (ARMD) Clinical Trial

— EFFECT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01499628
• Other study ID #: RUBG1008
• Secondary ID: Fight for Sight
• Status: Completed
• Phase: N/A
• Start date: April 27, 2011
• Est. completion date: December 31, 2015

Study information

• Verified date: December 2023
• Source: Moorfields Eye Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 31, 2015
• Est. primary completion date: November 26, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age Related Macular Degeneration (ARMD)
• Macular Degeneration

Intervention

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
• 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.
• 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.

Locations

Country	Name	City	State
United Kingdom	Moorfields Eye Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
Moorfields Eye Hospital NHS Foundation Trust	British Eye Research Foundation, operating as Fight for Sight

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score on the Massof Activity Inventory - 6 month follow up		Change from Baseline in Massof Activity Inventory at 6 month follow up
Secondary	Reading Speed (ReST) - Final Assessment		Change from Baseline in Reading Speed (ReST) at Final Assessment
Secondary	Quality of Life (MacDQoL) - Final Assessment		Change from Baseline in Quality of Life (MacDQoL) at Final Assessment
Secondary	Quality of Life (MacDQoL) - 6 month follow up		Change from Baseline in Quality of Life (MacDQoL) at 6 month follow up
Secondary	Quality of Life (MacDQoL) - 12 month follow up		Change from Baseline in Quality of Life (MacDQol) at 12 month follow up
Secondary	Self-reported health status (EQ-5D) - Final Assessment		Change from Baseline in EQ-5D score at Final Assessment
Secondary	Self-reported health status (EQ-5D) - 6 month follow up		Change from Baseline in EQ-5D score at 6 month follow up
Secondary	Self-reported health status (EQ-5D) - 12 month follow up		Change from Baseline in EQ-5D score at 12 month follow up
Secondary	Time Trade Off (TTO) - 6 month follow up		Change from Baseline in Time Trade Off (TTO) score at 6 month follow up
Secondary	WHO (Five) Well-Being Index (WBI-5) - Final Assessment		Change from Baseline in WBI-5 score at Final Assessment
Secondary	WHO (Five) Well-Being Index (WBI-5) - 6 month follow up		Change from Baseline in WBI-5 score at 6 month follow up
Secondary	WHO (Five) Well-Being Index (WBI-5) - 12 month follow up		Change from Baseline in WBI-5 score at 12 month follow up
Secondary	Interpersonal Support Evaluation List (ISEL) - Final Assessment		Change from Baseline in Interpersonal Support Evaluation List (ISEL) at Final Assessment
Secondary	Interpersonal Support Evaluation List (ISEL) - 6 month follow up		Change from Baseline in Interpersonal Support Evaluation List (ISEL) at 6 month follow up
Secondary	Interpersonal Support Evaluation List (ISEL) - 12 month follow up		Change from Baseline in Interpersonal Support Evaluation List (ISEL) at 12 month follow up
Secondary	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
Secondary	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
Secondary	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
Secondary	Massof Activity Inventory - Final Assessment		Change from Baseline in Massof Activity Inventory at Final Assessment
Secondary	Massof Activity Inventory - 12 month follow up		Change from Baseline in Massof Activity Inventory at 12 month follow up