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

NCT07330713 | Completed

• 1 other identifier: 2019-21/36
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nonarteritic Anterior Ischemic Optic Neuropathy

Keywords

nonarteritic anterior ischemic optic neuropathy, platelet-rich plasma, subtenon injection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

PRP Treatment Group

EXPERIMENTAL

Participants receive posterior subtenon autologous platelet-rich plasma injections in addition to standard clinical follow-up.

Biological: Autologous Platelet-Rich Plasma (PRP)

Control Group

NO INTERVENTION

Participants are managed with observation alone and receive no interventional treatment.

Interventions

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.

PRP Treatment Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uludag University: lead

Study Sites (1)

Uludag University, Department of Ophthalmology

Bursa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Optic Neuropathy, Ischemic

Condition Hierarchy (Ancestors)

Optic Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Gamze Ucan Gündüz, MD

  Uludag University, Department of Ophthalmology

  PRINCIPAL INVESTIGATOR

• Selim Doganay, MD

  Uludag University, Department of Ophthalmology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Eligible participants are randomly assigned to one of two parallel groups. One group receives posterior subtenon autologous platelet-rich plasma injections, while the control group is managed with observation alone. Participants remain in their assigned groups throughout the study period.

Study Record Dates

• First Submitted: December 28, 2025
• First Posted: January 9, 2026
• Study Start: January 1, 2022
• Primary Completion: January 31, 2024
• Study Completion: May 31, 2024
• Last Updated: January 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)