Benha University
Banhā, Benha, 13111, Egypt
NCT Number: NCT07405489
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Banhā, Benha, 13111, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Diagnosis of definite or probable acute ocular Vogt-Koyanagi-Harada (VKH) disease
Active intraocular inflammation (choroiditis, serous retinal detachment, or panuveitis)
No prior treatment for the current VKH episode
Minimum follow-up of 6 months with complete medical records, including BCVA and OCT data
Exclusion criteria
Use of immunosuppressive or biologic agents at presentation
Pre-existing glaucoma, ocular hypertension, or advanced cataract
Retinal diseases affecting visual outcomes (e.g., diabetic retinopathy, age-related macular degeneration)
Incomplete medical records or missing OCT/BCVA data
Time frame: 3 months from treatment initiation
Complete control of ocular inflammation is defined as a composite outcome, achieved when all of the following criteria are met at the 3-month visit:
Absence of active intraocular inflammation on clinical examination
Complete resolution of subretinal fluid on optical coherence tomography (OCT)
Stable or improved best-corrected visual acuity (BCVA) compared with baseline
Unit of Measure: Proportion of participants (%)
Time frame: Baseline, 1 month, 3 months, and 6 months
Change in BCVA measured in logarithm of the minimum angle of resolution (logMAR) units during follow-up.
Time frame: Baseline, 3 months, 6 months
Presence or absence of subretinal fluid on OCT imaging during follow-up.
Time frame: Baseline, 3 months, and 6 months
Change in central macular thickness measured by OCT.
Benha University
Other
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
Acronym: VKH-OC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03811366
Autoimmune Diseases, Autoimmune Diseases of the Nervous System
São Paulo, Brazil
View Trial DetailsNCT02015351
Autoimmune Diseases, Autoimmune Diseases of the Nervous System
São Paulo, Brazil
View Trial DetailsNCT05031143
Autoimmune Diseases, Autoimmune Diseases of the Nervous System
Banhā, Qualiobeya, Egypt
View Trial DetailsNCT03399175
Autoimmune Diseases, Autoimmune Diseases of the Nervous System
São Paulo, Brazil
View Trial Details