CompletedNot Applicable

Platelet-Rich Plasma for Acute Nonarteritic Anterior Ischemic Optic Neuropathy: A Prospective Randomized Controlled Study

Turkey (Türkiye)31 participantsStarted 2022-01-01

Plain-language summary

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.

Who can participate

Age range40 Years

SexALL

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Inclusion Criteria: * 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 Exclusion Criteria: * 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

What they're measuring

Change in Best-Corrected Visual Acuity (BCVA)

Timeframe: Baseline (Week 0) to Week 16

Trial details

NCT IDNCT07330713

SponsorUludag University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-31