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Completed

NCT Number: NCT01499628

EFFECT:Eccentric Fixation From Enhanced Clinical Training

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Moorfields Eye Hospital

London, EC1V 2PD, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supervised Reading

Behavioral

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

Behavioral

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

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.

Primary outcomes

  1. 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 outcomes

  1. Reading Speed (ReST) - Final Assessment

    Time frame: Change from Baseline in Reading Speed (ReST) at Final Assessment

  2. Quality of Life (MacDQoL) - Final Assessment

    Time frame: Change from Baseline in Quality of Life (MacDQoL) at Final Assessment

  3. Quality of Life (MacDQoL) - 6 month follow up

    Time frame: Change from Baseline in Quality of Life (MacDQoL) at 6 month follow up

  4. Quality of Life (MacDQoL) - 12 month follow up

    Time frame: Change from Baseline in Quality of Life (MacDQol) at 12 month follow up

  5. Self-reported health status (EQ-5D) - Final Assessment

    Time frame: Change from Baseline in EQ-5D score at Final Assessment

  6. Self-reported health status (EQ-5D) - 6 month follow up

    Time frame: Change from Baseline in EQ-5D score at 6 month follow up

  7. Self-reported health status (EQ-5D) - 12 month follow up

    Time frame: Change from Baseline in EQ-5D score at 12 month follow up

  8. Time Trade Off (TTO) - 6 month follow up

    Time frame: Change from Baseline in Time Trade Off (TTO) score at 6 month follow up

  9. WHO (Five) Well-Being Index (WBI-5) - Final Assessment

    Time frame: Change from Baseline in WBI-5 score at Final Assessment

  10. 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

  11. 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

  12. Interpersonal Support Evaluation List (ISEL) - Final Assessment

    Time frame: Change from Baseline in Interpersonal Support Evaluation List (ISEL) at Final Assessment

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. Massof Activity Inventory - Final Assessment

    Time frame: Change from Baseline in Massof Activity Inventory at Final Assessment

  19. Massof Activity Inventory - 12 month follow up

    Time frame: Change from Baseline in Massof Activity Inventory at 12 month follow up

Sponsors and collaborators

Lead sponsor

Moorfields Eye Hospital NHS Foundation Trust

Other

Collaborators

  • British Eye Research Foundation, operating as Fight for Sight

Registry information

Official study title

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

Acronym: EFFECT

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Dec 26, 2011
Registry last updated
Dec 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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