The objective of this prospective, randomized, comparative clinical trial was to evaluate the therapeutic equivalence and safety profile of two commonly used topical corticosteroids in the management of pediatric anterior chamber (AC) granulomas.
While topical steroids are the established first-line therapy for this condition, steroid-induced intraocular pressure (IOP) elevation remains a significant clinical concern, particularly in pediatric populations.
Study Methodology and Intervention:
Participants were randomized into two treatment arms to receive different topical regimens:
* Group 1 (Loteprednol): Received loteprednol etabonate 1% eye drops four times daily.
* Group 2 (Prednisolone): Received prednisolone acetate 1% eye drops six times daily.
The treatment followed a standardized protocol where dosing was spaced throughout waking hours, and bottles of prednisolone acetate (a suspension) were shaken before use to ensure dose uniformity.
Following the initial fixed-dosing phase, a clinician-guided tapering schedule was implemented based on the improvement of SUN anterior chamber activity and the reduction or clearance of the AC lesion observed during slit-lamp examinations.
Clinical Monitoring and Safety Safeguards; Patient assessments were conducted at baseline, day 1, 2 weeks, 1 month, and 3 months.
These evaluations included: Inflammatory Grading: Standardized SUN criteria for AC cells and flare.
Lesion Assessment: Slit-lamp examination to categorize granuloma status as persistent, improved, or resolved.Safety Monitoring: Goldmann applanation tonometry was used to measure IOP at every visit, with specific safety endpoints defined as IOP \> 21 mmHg, or an increase from baseline \> 5 mmHg.
To prioritize patient safety, a strict "non-responder" protocol was enforced. Any patient who failed to demonstrate adequate clinical improvement (defined as persistent granuloma or clinically significant inflammation despite protocol-driven treatment) after 4 weeks was classified as a non-responder and immediately referred for surgical intervention.
Scientific Rationale:
The study aimed to determine if the "soft drug" design of loteprednol etabonate-which undergoes rapid transformation to inactive metabolites-could achieve similar anti-inflammatory results as the ketone-based prednisolone acetate while reducing the risk of extracellular matrix remodeling in the trabecular meshwork that typically drives steroid-induced ocular hypertension.
