The trial, led by Alyssa Godfrey from Drexel University College of Medicine, Philadelphia, evaluated whether a commercially available microdosing spray could match the effectiveness of conventional eye drops used during routine pediatric eye examinations. Pupillary dilation is essential for accurate retinal evaluation and refraction, but the discomfort and anxiety associated with eye drops often make the process challenging in children.
Researchers conducted a prospective, randomized, single-masked non-inferiority trial involving 67 children undergoing scheduled eye examinations that required dilation. The participants had a mean age of 8.8 years, and approximately 60% were boys. Each child received dilation in both eyes, with one eye randomly assigned to standard eye drops and the other to the spray device. The conventional approach involved one drop each of tropicamide 1% and phenylephrine 2.5%, while the spray group received two 8-microliter sprays containing the same medications.
Baseline pupil size, refractive error, and intraocular pressure were measured before administration, and follow-up assessments were performed 30 minutes later. The primary outcomes focused on changes in maximum pupil diameter and the percentage of pupillary constriction, which are key indicators of adequate mydriasis.
The study led to the following findings:
• The ophthalmic spray was non-inferior to standard eye drops for both primary endpoints assessing pupillary dilation.
• The spray achieved a slightly larger maximum pupil diameter compared with eye drops and produced a marginally greater reduction in pupillary constriction percentage, meeting prespecified non-inferiority criteria.
• Clinically inadequate dilation (≤ 6.0 mm) was uncommon in both groups, occurring in one eye in the spray group and two eyes in the eye-drop group.
• No adverse effects were reported with either delivery method, indicating a favorable safety profile for the spray.
• Patient preference favored the spray, with 67% of children preferring it over traditional eye drops, likely due to reduced discomfort, minimal spillage, and a less intimidating mode of administration.
The investigators highlighted a practical limitation of standard eye drops: commercial droppers typically dispense volumes far exceeding what the conjunctival sac can absorb. This excess leads to medication overflow, waste, and potentially higher systemic absorption. In contrast, the microdosing spray delivers a much smaller volume, aligning more closely with ocular absorption capacity.
The authors concluded that small-volume ophthalmic sprays containing tropicamide and phenylephrine can provide effective pupillary dilation in children while improving comfort and acceptability. They noted that further research is needed to evaluate the cycloplegic effects of spray delivery. If confirmed, this approach could represent a meaningful shift in pediatric ophthalmic practice by maintaining diagnostic accuracy while enhancing the patient experience.
Reference:
Godfrey, A., Menon, S., Takla, P., Lu, J., Chen, T., Bass, O., Brown, M., Indaram, M., & Oatts, J. T. (2025). A Small Volume Topical Ophthalmic Spray for Pupillary Dilation in Children: A Randomized, Masked Non-inferiority Trial. Ophthalmology. https://doi.org/10.1016/j.ophtha.2025.11.009
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