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NCT Number: NCT07330713

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

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.

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Key information

Conditions

Nonarteritic Anterior Ischemic Optic Neuropathy Cardiovascular Diseases Cranial Nerve Diseases Eye Diseases Nervous System Diseases Optic Nerve Diseases Optic Neuropathy, Ischemic Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uludag University, Department of Ophthalmology

Bursa, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous Platelet-Rich Plasma (PRP)

Biological

Autologous platelet-rich plasma is prepared from the participant's own blood and administered via posterior subtenon injection at scheduled visits.

Primary outcomes

  1. Change in Best-Corrected Visual Acuity (BCVA)

    Time frame: 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.

Secondary outcomes

  1. Change in Visual Field Mean Deviation (MD) and Visual Field Index (VFI)

    Time frame: Baseline (Week 0) to Week 16

    Change in visual field mean deviation (MD) and visual field index (VFI) measured by automated perimetry (Humphrey Field Analyzer 30-2) from baseline to week 16.

  2. Change in Peripapillary Retinal Nerve Fiber Layer (RNFL) Thickness

    Time frame: Baseline (Week 0) to Week 16

    Change in global and sectoral peripapillary retinal nerve fiber layer thickness measured by spectral-domain optical coherence tomography (OCT) from baseline to week 16.

Sponsors and collaborators

Lead sponsor

Uludag University

Other

Registry information

Acronym: PRP-NAION

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 9, 2026
Registry last updated
Jan 9, 2026

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.

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