Vision rehabilitation using microperimetric biofeedback training in age-related macular degeneration
LB.02.01/2.3/039/2021 | Not specified | Widihastha SH et al. (2023)
Widihastha SH, Iskandar E, Satari K, Irfani I, Virgana R, Amiruddin PO. Vision rehabilitation using microperimetric biofeedback training in age-related macular degeneration. Int J Ophthalmol, 2023; 16(6):933-938.
Locations
Conducted in Indonesia at the National Eye Center Cicendo Eye Hospital
Study Period
March – June 2022
Study Design
Prospective, randomized, interventional, comparative study
Study Population
Experimental Group
Control Group
Follow-up Time: 6 weeks
Outcomes
Durability
Not reported
Vision
Best-Corrected Visual Acuity (BCVA)
The mean ±SD change in BCVA (logMAR) after 6 weeks (Primary Outcome):
• MBFT group: -0.42 ± 0.25
• Control group: -0.01 ± 0.05
• Comparison: p <0.001
Near Vision Acuity (NVA)
The mean ±SD change in NVA (logMAR) after 6 weeks:
• MBFT group: -0.33 ± 0.16
• Control group: -0.01 ± 0.05
• Comparison: p <0.001
Other
Vision related quality of Life (QoL)
Reading Rate
The mean ±SD change in Reading Rate (words/min) after 6 weeks:
• MBFT group: +24.2 ± 14.9
• Control group: -1.8 ± 6.8
• Comparison: p<0.001
Immunognicity
Not reported
Pharmokinetics
Not reported
Anatomic
Safety
Not reported
Conclusion
Microperimetric biofeedback training significantly improved BCVA, near vision acuity, and reading rate in AMD patients compared to standard care. The intervention was well tolerated with no reported adverse events.
Risk of Bias Assessment for Primary Outcome
Randomization Process
Some concerns
Note: There is no information on the allocation concealment or the method of randomization. However, the two groups were comparable at the baseline.
Missing Outcome Data
Low risk
Note: “There was no drop-out reported during the process.”
Selection of the Reported Results
Low risk Note: the protocol was not publicly available.
Deviations from Intended Observations
Low risk Note: “A total of 36 eyes from 36 patients diagnosed with AMD were included in this study. There was no drop-out reported during the process.”
Measurement of the Outcome
Some concerns Note: This is a single site study. No information on whether the assessors were masked. Although there is no information, it was unlikely that assessment of the outcome was influenced by knowledge of intervention received.
Overall
Some concerns