NCT07405489

Oral Prednisolone Versus Posterior Sub-Tenon Triamcinolone for Acute Ocular VKH

A Retrospective Comparative Cohort Study Evaluating the Efficacy, Anatomical Outcomes, Recurrence Rates, and Safety of Oral Prednisolone Versus Posterior Sub-Tenon Triamcinolone Acetonide as Initial Therapy in Acute Ocular Vogt-Koyanagi-Harada Disease

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Benha University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Vogt-Koyanagi-Harada (VKH) disease is a rare autoimmune disorder characterized by bilateral ocular inflammation that may lead to serous retinal detachment and permanent visual impairment if not promptly treated. Systemic corticosteroids are commonly used as first-line therapy; however, periocular corticosteroid administration has been proposed as an alternative approach that may reduce systemic adverse effects. This retrospective cohort study reviewed the medical records of patients with acute ocular VKH disease to compare two initial treatment strategies: systemic oral prednisolone and posterior sub-Tenon triamcinolone acetonide (PST/STA). The primary objective was to evaluate control of ocular inflammation three months after treatment initiation. Secondary objectives included assessment of visual acuity changes over six months, anatomical recovery on optical coherence tomography (OCT), recurrence of inflammation, need for additional therapy, and treatment-related adverse events.

Detailed description

This retrospective comparative observational cohort study evaluated the efficacy and safety of oral prednisolone versus posterior sub-Tenon triamcinolone acetonide (PST/STA) as initial therapy for acute ocular Vogt-Koyanagi-Harada (VKH) disease. The study was conducted at the Ophthalmology Department, Faculty of Medicine, Benha University, Egypt, through a review of electronic and paper-based medical records of patients treated between January 2021 and December 2025. Eligible patients were adults diagnosed with acute ocular VKH disease who had not received prior systemic or periocular corticosteroid therapy and who had a minimum follow-up duration of six months. Patients were managed according to routine clinical practice and received either systemic oral prednisolone or PST/STA as initial treatment, based on treating physician discretion. Both eyes of each patient were treated using the same modality, and analyses were performed at the patient level. Patients in the oral prednisolone group received an initial dose of approximately 1 mg/kg/day (maximum 80 mg/day), followed by gradual tapering over 3-6 weeks. Patients in the PST/STA group received a posterior sub-Tenon injection of triamcinolone acetonide (40 mg/1 mL), with repeat injection considered if clinically indicated. Topical corticosteroids and cycloplegics were permitted in both groups. Systemic corticosteroids were reserved as rescue therapy in the PST/STA group when necessary. Data extracted from medical records included demographic characteristics, baseline ophthalmic findings, best-corrected visual acuity (BCVA), OCT parameters, follow-up clinical assessments, recurrence episodes, requirement for rescue therapy, and ocular or systemic adverse events. The primary outcome measure was control of ocular inflammation at three months following initiation of therapy. Secondary outcome measures included longitudinal changes in BCVA, OCT-based anatomical recovery, recurrence of inflammation, need for additional treatment, and treatment-related adverse events during follow-up. Statistical analysis was planned using appropriate parametric or non-parametric tests for between-group comparisons, survival analysis methods for time-to-event outcomes, and a significance threshold of p \< 0.05. The study protocol was approved by the Institutional Review Board of the Faculty of Medicine, Benha University (Approval No. RC 11\_1\_2026). Due to the retrospective nature of the study, informed consent was waived. The study was conducted in accordance with the principles of the Declaration of Helsinki.

Conditions

• VKH Syndrome

Timeline

• Start date: 2021-01-01
• Primary completion: 2025-10-01
• Completion: 2025-12-01
• First posted: 2026-02-12
• Last updated: 2026-02-12

Locations

1 site across 1 country: Egypt