Randomized Controlled Trial of a Spectacle Lens for Macular Degeneration
NTR 6126 (Dutch Trial Register) | | Visser MS et al. (2020) - Randomized
Visser MS, Timman R, Kampen-Smalbrugge J, et al. Randomized Controlled Trial of a Spectacle Lens for Macular Degeneration. Optom Vis Sci, 2020; 97:889–897.
Locations
8 low-vision clinics in the Netherlands
Study Period
September 2014 – July 2016
Study Design
Randomized, controlled, open-label, parallel-group trial
Study Population
Experimental Group
Control Group
Follow-up Time: 6 weeks
Outcomes
Durability
Not reported
Vision
Best-Corrected Visual Acuity (BCVA) Change in BCVA (logMAR, binocular):
• E-Scoop group: -0.05 logMAR (2.5 letters)
• Control group: No change
• p < 0.001, statistically significant but not clinically relevant Contrast Sensitivity Change in contrast sensitivity (logCS, binocular):
• E-Scoop group: +0.10 logCS (2 letters)
• Control group: No change
• p < 0.001, statistically significant but not clinically relevant
Other
Quality of Life (QoL) Vision-Related QoL Change in quality of life (NEI VFQ-25 Rasch score, primary outcome):
• E-Scoop group: -0.11
• Control group: -0.07
• Difference: -0.04 (p = 0.53, NS).
Immunognicity
Not reported
Pharmokinetics
Not reported
Anatomic
Not reported
Safety
Treatment-emergent AEs One case of yellow skin discoloration in the E-Scoop group (patient withdrew). Serious ocular AEs None reported. Non-ocular AEs None were reported, except for yellow skin in one patient.
Conclusion
E-Scoop did not improve quality of life compared to standard vision correction. Small, statistically significant improvements in visual acuity and contrast sensitivity were found, but they were not clinically meaningful. The study does not support E-Scoop as an effective intervention for AMD patients.
Risk of Bias Assessment for Primary Outcome
Randomization Process
Some concerns
Note: the method of randomization and allocation concealment was not supplied. However, the baseline characteristics of the two groups are comparable.
Missing Outcome Data
Some concerns
Note: The missing data of the total patients = 15.1% (28/185). However, the sample size anticipants have considered the high dropout of this study. In addition, the missingness is unlikely, depending on the true value.
Selection of the Reported Results
Low risk Note: Registration with the protocol
Deviations from Intended Observations
Some concerns Note: This is an open-label study. There is no information on whether the deviations arose because of the study context. ITT was applied for the primary outcome analysis.
Measurement of the Outcome
Some concerns Note: This is an open-label study, and the QoL is a patient’s reported outcome. It is unlikely that the measurement can influenced by the knowledge of the intervention.
Overall
High risk