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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRP Treatment Group | Experimental | Participants receive posterior subtenon autologous platelet-rich plasma injections in addition to standard clinical follow-up. |
|
| Control Group | No Intervention | Participants are managed with observation alone and receive no interventional treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Gamze Ucan Gündüz, MD | Uludag University, Department of Ophthalmology | Principal Investigator |
| Selim Doganay, MD | Uludag University, Department of Ophthalmology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uludag University, Department of Ophthalmology | Bursa | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D018917 | Optic Neuropathy, Ischemic |
| ID | Term |
|---|---|
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
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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.
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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 |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |