Platelet-Rich Plasma for Acute Nonarteritic Anterior Ischemic Optic Neuropathy: A Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Change in Best-Corrected Visual Acuity (BCVA)
研究概览
简要总结
This prospective randomized clinical study aims to evaluate the efficacy and safety of autologous platelet-rich plasma (PRP) injection in patients with acute non-arteritic anterior ischemic optic neuropathy (NAION). Eligible patients are randomly assigned to receive posterior subtenon PRP injections or to an observation-only control group. The PRP group receives injections at baseline and during follow-up. Comprehensive ophthalmologic evaluations, including best-corrected visual acuity, visual field testing, and retinal nerve fiber layer thickness measurements, are performed at baseline and scheduled follow-up visits. The primary outcomes include changes in visual function and structural optic nerve parameters, as well as the incidence of treatment-related adverse events.
详细描述
This prospective randomized clinical study is designed to evaluate the efficacy and safety of posterior subtenon autologous platelet-rich plasma (PRP) injection in patients diagnosed with acute non-arteritic anterior ischemic optic neuropathy (NAION). Patients meeting the inclusion criteria are enrolled and randomly assigned, using computer-assisted randomization, to either the PRP treatment group or an observation-only control group.
Patients in the PRP group receive posterior subtenon injections of autologous PRP at baseline and during scheduled follow-up visits. The control group is managed with observation alone and receives no interventional treatment. All participants undergo comprehensive ophthalmologic examinations at baseline and at predefined follow-up visits, including assessments of best-corrected visual acuity, visual field testing, and retinal nerve fiber layer thickness measurements obtained by optical coherence tomography.
Patients are followed longitudinally to assess changes in functional and structural optic nerve parameters, as well as to monitor for any ocular or systemic adverse events related to the intervention. Safety evaluations are performed at each follow-up visit throughout the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of acute non-arteritic anterior ischemic optic neuropathy (NAION) based on clinical history and ophthalmologic examination
- •Acute, painless vision loss and/or visual field defect
- •Symptom onset within 14 days prior to enrollment
- •Age 40 years or older
- •Ability to cooperate with best-corrected visual acuity and visual field examinations
- •Willingness and ability to complete all follow-up visits (weeks 1, 3, 6, 8, and 16)
- •Provision of written informed consent
排除标准
- •Arteritic anterior ischemic optic neuropathy
- •Posterior ischemic optic neuropathy
- •Age under 40 years
- •Presence of concomitant ocular diseases that could affect visual outcomes (e.g., glaucoma, diabetic macular edema, retinal dystrophy)
- •Presence of neurological diseases that may affect the optic nerve (e.g., demyelinating disease, intracranial or intraorbital mass)
- •Inability to cooperate with visual acuity or visual field testing
- •Presence of systemic hematological disorders that could interfere with platelet-rich plasma preparation
研究组 & 干预措施
PRP Treatment Group
Participants receive posterior subtenon autologous platelet-rich plasma injections in addition to standard clinical follow-up.
干预措施: Autologous Platelet-Rich Plasma (PRP) (Biological)
Control Group
Participants are managed with observation alone and receive no interventional treatment.
结局指标
主要结局
Change in Best-Corrected Visual Acuity (BCVA)
时间窗: Baseline (Week 0) to Week 16
Change in best-corrected visual acuity from baseline (week 0) to week 16, measured in logarithm of the minimum angle of resolution (logMAR) units using standard visual acuity charts.
次要结局
- Change in Visual Field Mean Deviation (MD) and Visual Field Index (VFI)(Baseline (Week 0) to Week 16)
- Change in Peripapillary Retinal Nerve Fiber Layer (RNFL) Thickness(Baseline (Week 0) to Week 16)
研究者
Gamze Uçan Gündüz
Associate Professor
Uludag University