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临床试验/NCT07405489
NCT07405489已完成不适用

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

Benha University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年1月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Proportion of Participants Achieving Complete Control of Ocular Inflammation at 3 Months

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years
  • 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

排除标准

  • Prior systemic or periocular corticosteroid therapy for VKH
  • 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

研究组 & 干预措施

Oral Prednisolone Group

Patients received oral prednisolone at 1 mg/kg/day (maximum 80 mg/day) as initial therapy for acute ocular VKH. The full dose was given for ~1 week followed by gradual taper over 3-6 weeks. Topical corticosteroids and cycloplegics were allowed as adjunct therapy.

Posterior Sub-Tenon Triamcinolone (PST/STA) Group

Patients received a posterior sub-Tenon injection of triamcinolone acetonide (40 mg/1 mL) as initial therapy for acute ocular VKH. A second injection at 4-6 weeks was administered if residual inflammation persisted. Systemic steroids were not used unless rescue criteria were met.

结局指标

主要结局

Proportion of Participants Achieving Complete Control of Ocular Inflammation at 3 Months

时间窗: 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 (%)

次要结局

  • Change in Best-Corrected Visual Acuity (BCVA)(Baseline, 1 month, 3 months, and 6 months)
  • Resolution of Subretinal Fluid on Optical Coherence Tomography (OCT)(Baseline, 3 months, 6 months)
  • Change in Central Macular Thickness (CMT)(Baseline, 3 months, and 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ehab Mohamed Elsayed Mohamed Saad

Lecturer

Benha University

研究点 (1)

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