Vision-Related Quality of Life and Dry Eye Symptoms After Treatment with Lyophilized Amniotic Membrane Eye Drops: A Secondary Analysis of a Prospective Cohort Study

Background/Objectives: Dry eye disease (DED) affects daily visual functioning and vision-related quality of life in addition to tear film stability and ocular surface integrity. In a previously published prospective cohort, lyophilized amniotic membrane (AM) eye drops were associated with significant improvements in objective ocular surface parameters. This secondary analysis evaluated whether treatment with lyophilized AM eye drops was accompanied by changes in patient-reported outcomes, specifically vision-related quality of life and dry eye symptoms. Methods: This secondary analysis included 40 consecutive patients with DED treated with lyophilized AM eye drops in repeated 14-day cycles over six study visits, while continuing their pre-existing standard DED therapy. Patient-reported outcomes were assessed at baseline and at the final visit using the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) and the Ocular Surface Disease Index-6 (OSDI-6). Item-level response distributions were compared between baseline and the final visit using non-parametric tests for paired ordinal data. A two-sided p value < 0.05 was considered statistically significant. Results: Global NEI VFQ-25 items, including general health, self-rated vision, and worry about eyesight, did not change significantly. In contrast, significant improvements were observed in ocular pain/discomfort (p = 0.002); near-vision activities, including reading ordinary print (p = 0.003), work or hobbies requiring near vision (p = 0.014); and finding objects on a crowded shelf or in a drawer (p = 0.008), as well as distance-related and spatial tasks, including reading street signs (p < 0.001) and noticing objects off to the side while walking (p = 0.037). Improvements were also observed in vision-related social functioning and dependence-related items. Five of six OSDI-6 items improved significantly: light sensitivity (p < 0.001), blurred vision (p = 0.008), difficulty with driving or night driving (p = 0.002), difficulty watching television (p = 0.008), and discomfort in windy conditions (p = 0.046). Discomfort in low-humidity environments showed a trend toward improvement but did not reach statistical significance (p = 0.059). Conclusions: In this secondary analysis of a prospective cohort, lyophilized AM eye drops were associated with significant improvements in several patient-reported domains of vision-related quality of life and dry eye symptoms. These findings complement previously reported objective improvements in tear film stability, ocular surface staining, meibomian gland function, and corneal sensitivity, suggesting that treatment with lyophilized AM eye drops was associated with improvements extending beyond ocular surface signs to patient-reported daily visual function and symptom burden in patients with DED.