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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Autologous platelet-rich plasma is prepared from the participant's own blood and administered via posterior subtenon injection at scheduled visits.
Uludag University, Department of Ophthalmology
Bursa, Turkey (Türkiye)
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.
Time frame: Baseline (Week 0) to Week 16
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.
Time frame: 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.
Time frame: Baseline (Week 0) to Week 16
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