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

NCT ID: NCT07330713

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2024-05-31

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.

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.

Conditions

Nonarteritic Anterior Ischemic Optic Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PRP Treatment Group

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

Group Type: EXPERIMENTAL

Autologous Platelet-Rich Plasma (PRP)

Intervention Type: BIOLOGICAL

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

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uludag University

OTHER

Sponsor Role: lead

Responsible Party

Gamze Uçan Gündüz

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gamze Ucan Gündüz, MD

Role: PRINCIPAL_INVESTIGATOR

Uludag University, Department of Ophthalmology

Selim Doganay, MD

Role: PRINCIPAL_INVESTIGATOR

Uludag University, Department of Ophthalmology

Locations

Uludag University, Department of Ophthalmology

Bursa, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2019-21/36

Identifier Type: -

Identifier Source: org_study_id