Eccentric Viewing Training for Age-Related Macular Disease: Results of a Randomized Controlled Trial (the EFFECT Study)

NCT01499628 | EFFECT | Rubin GS et al. (2024)

Rubin, G. S., Crossland, M. D., Dunbar, H. M. P., Brown, G. M., Petriti, B., Roche, H., Sirrell, S. V., Broom, K. T., Hamilton, R. D. Eccentric Viewing Training for Age-Related Macular Disease: Results of a Randomized Controlled Trial (the EFFECT Study). Ophthalmology Science, 2024; 4:100422.

Locations

United Kingdom

Study Period

August 2012 to December 2012

Study Design

Randomized, multicenter, controlled trial

Study Population

Characteristic:

Type of AMD:

1 (Dry AMD) and 2 (Wet AMD)

AMD Stage:

1 to 3 (All stages)

Total Sample Size:

200 randomized into 4 groups (Control: 50, Supervised Reading: 50, PRL Training: 50, TRL Training: 50)

Age:

Randomized, multicenter, controlled trial

Sex (Male) n%:

Not reported

Experimental Group

Intervention Therapy:

• PRL training: standard low-vision rehabilitation plus three 45-minute sessions of PRL training • TRL training: standard low-vision rehabilitation plus three 45-minute sessions of TRL training

Dose & Frequency:

• 3 sessions of training using their preferred retinal locus (PRL) • 3 sessions of biofeedback training for a theoretically optimal trained retinal locus (TRL)

Age (Years):

• PRL training=80.3±6.0 • TRL training=81.4±6.7

Number of Patients:

• PRL training=51 • TRL training=53

Male N %:

• PRL training=28 (54.9%) • TRL training=37 (69.8%)

Patients Followed Up:

• PRL training=44 • TRL training=45

Control Group

Intervention Therapy:

• Supervised reading: low vision rehabilitation (control treatment) plus three 45-minute sessions of supervised reading. • Standard low vision rehabilitation only.

Dose & Frequency:

• Standard rehabilitation plus 3 sessions of supervised reading practice • Standard rehabilitation without eccentric viewing training

Age (Years):

• Supervised reading=82.4±8.4 • Standard rehabilitation=81.6 ±7.4

Number of Patients:

• Supervised reading=49 • Standard rehabilitation=47

Male N %:

• Supervised reading=30 (61.2%) • Standard rehabilitation=27 (57.4%)

Patients Followed Up:

• Supervised reading=44 • Standard rehabilitation=43

Follow-up Time: 26 weeks

Outcomes

Durability

Not reported

Vision

Best-corrected visual acuity (BCVA)
• There was no significant difference in visual acuity change between those with dry AMD (mean change = 0.21 logMAR [SD: 0.42]) and those with wet AMD (mean change= 0.19 logMAR [SD: 0.50], ANOVA between wet and dry AMD, P = 0.78).
• There was no difference between groups in the magnitude of visual acuity change (ANOVA between groups, P = 0.75).
• There was no difference between groups in the magnitude of contrast sensitivity change (ANOVA between groups, P = 0.08).

Other

Primary Outcome: Patient-Reported Visual Task Ability
No significant difference between groups in change in visual task ability (F (3,174) = 1.48, p = 0.22).
Reading Performance
No significant difference in reading speed change between groups (F (3,168) = 1.17, p = 0.32).
Fixation Stability
No significant difference in fixation stability changes between groups (F (3,137) = 0.57, p = 0.64).

Immunognicity

Not reported

Pharmokinetics

Not reported

Anatomic

Not reported

Safety

Not reported

Outcomes

Conclusion

Eccentric viewing training did not significantly improve task ability, reading performance, or fixation stability. The results do not support routine use of this training for people with progressing age-related macular disease.

Risk of Bias Assessment for Primary Outcome

Randomization Process

Some concerns

Note: No information on the methods for randomization and concealment of the allocation sequence. However, the baseline characteristics are balanced between the groups.

Missing Outcome Data

Some concerns

Note: No sensitivity analysis or appropriate imputation (‘last-observation-carried-forward’ was used in the study) was applied. Therefore, there is no evidence that the result was not biased by missing outcome data. However, it is unlikely that missingness in the outcome depended on its true value (the reasons and rate of the missingness are balanced among the four groups).

Selection of the Reported Results

Low risk Note: Registration with the protocol.

Deviations from Intended Observations

Some concerns Note: Both participants and the personnel aware of the treatments. There were deviations from the intended intervention that arose because of the trial context (e.g., unhappy of the allocation, leave with no reasons, and discontinuous). However, the deviations are balanced among the groups. Therefore, the deviation is unlikely affect the outcome. ITT principle was applied for the data analysis.

Measurement of the Outcome

Low risk Note: The primary outcome measure for this study was visual task ability assessed using the AI after 6 months.

Overall

High risk