EFFECT:Eccentric Fixation From Enhanced Clinical Training

Moorfields Eye Hospital NHS Foundation Trust

Status: Completed

Conditions: Age Related Macular Degeneration (ARMD)

Treatments: Behavioral: EVT at the PRL; Behavioral: EVT at the TRL; Behavioral: Supervised Reading

Study type: Interventional

Funder types: Other

Identifiers

NCT01499628

RUBG1008

Fight for Sight Ref: 1777/78 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 4 patient groups

Group 1-Control

No Intervention group

Description:

No extra training will be given.

Group 2-Control plus supervised reading

Active Comparator group

Description:

The same amount of contact time as Groups 3 and 4 - three 45 minute sessions completed over three weeks.

Treatment:

Behavioral: Supervised Reading

Group 3-EVT at the PRL

Experimental group

Description:

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

Treatment:

Behavioral: EVT at the PRL

Group 4-EVT at the TRL

Experimental group

Description:

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

Treatment:

Behavioral: EVT at the TRL