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

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.

Study Overview

• Status: Completed
• Conditions: Nonarteritic Anterior Ischemic Optic Neuropathy
• Intervention / Treatment: Biological: Autologous Platelet-Rich Plasma (PRP)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Bursa, Turkey (Türkiye)
    • Uludag University, Department of Ophthalmology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRP Treatment Group; Participants receive posterior subtenon autologous platelet-rich plasma injections in addition to standard clinical follow-up.	Biological: Autologous Platelet-Rich Plasma (PRP); Autologous platelet-rich plasma is prepared from the participant's own blood and administered via posterior subtenon injection at scheduled visits.
No Intervention: Control Group; Participants are managed with observation alone and receive no interventional treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Best-Corrected Visual Acuity (BCVA)	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.	Baseline (Week 0) to Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Visual Field Mean Deviation (MD) and Visual Field Index (VFI)	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.	Baseline (Week 0) to Week 16
Change in Peripapillary Retinal Nerve Fiber Layer (RNFL) Thickness	Change in global and sectoral peripapillary retinal nerve fiber layer thickness measured by spectral-domain optical coherence tomography (OCT) from baseline to week 16.	Baseline (Week 0) to Week 16

Collaborators and Investigators

• Sponsor: Uludag University
• Investigators: Principal Investigator: Gamze Ucan Gündüz, MD, Uludag University, Department of Ophthalmology; Principal Investigator: Selim Doganay, MD, Uludag University, Department of Ophthalmology

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): January 31, 2024
• Study Completion (Actual): May 31, 2024

Study Registration Dates

• First Submitted: December 28, 2025
• First Submitted That Met QC Criteria: December 28, 2025
• First Posted (Actual): January 9, 2026

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: December 28, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: nonarteritic anterior ischemic optic neuropathy, platelet-rich plasma, subtenon injection
• Additional Relevant MeSH Terms: Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Eye Diseases; Optic Nerve Diseases; Cranial Nerve Diseases; Optic Neuropathy, Ischemic
• Other Study ID Numbers: 2019-21/36

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No