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CompletedNCT01499628EFFECTUpdated Dec 8, 2023

EFFECT:Eccentric Fixation From Enhanced Clinical Training

An interventional study of Supervised Reading and EVT at the PRL in Age Related Macular Degeneration (ARMD), sponsored by Moorfields Eye Hospital NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2023-12-08.

Sponsored by Moorfields Eye Hospital NHS Foundation Trust · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Apr 2011, registered Dec 2011).
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Age Related Macular Degeneration (ARMD)
03

In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's enrollment of 200 is above the median of 51 across 985 interventional studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Moorfields Eye Hospital NHS Foundation Trust is the lead sponsor of 48 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
200 participants (actual)

Study arms

  • 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

  • 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

  • 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

Interventions

  • BehavioralSupervised Reading

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

  • BehavioralEVT at the PRL

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

  • BehavioralEVT 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.

06

What researchers measure

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

07

Study locations

1 site
  • Moorfields Eye Hospital
    London, EC1V 2PD, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01499628
Lead sponsor
Moorfields Eye Hospital NHS Foundation Trust
Collaborators
British Eye Research Foundation, operating as Fight for Sight
Responsible party
Sponsor
First posted
Dec 26, 2011
Start date
Apr 27, 2011
Primary completion
Nov 26, 2015
Completion
Dec 31, 2015
Last update
Dec 8, 2023

Study contacts

Gary S Rubin, PhD
principal investigator · University College, London

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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