Nonarteritic Anterior Ischemic Optic NeuropathyPRP-NAIONNCT07330713
Platelet-Rich Plasma for Acute Nonarteritic Anterior Ischemic Optic Neuropathy: A Prospective Randomized Controlled Study
A study testing Autologous Platelet-Rich Plasma (PRP) in people with Nonarteritic Anterior Ischemic Optic Neuropathy, run by Uludag University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Nonarteritic Anterior Ischemic Optic Neuropathy
- What is being tested?
- Autologous Platelet-Rich Plasma (PRP)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Uludag University, Department of Ophthalmology
Bursa
About this study
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.
Read the 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.
- Being tested
- Autologous Platelet-Rich Plasma (PRP)
- Keywords
- nonarteritic anterior ischemic optic neuropathy, platelet-rich plasma, subtenon injection
- Medical subject headings
- Optic Neuropathy, Ischemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| PRP Treatment Group | Experimental | Participants receive posterior subtenon autologous platelet-rich plasma injections in addition to standard clinical follow-up. Receives: Biological: Autologous Platelet-Rich Plasma (PRP) |
| Control Group | No intervention | Participants are managed with observation alone and receive no interventional treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Week 0) to Week 16
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline (Week 0) to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start1 Jan 2022
- Primary completion31 Jan 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonarteritic Anterior Ischemic Optic NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Uçan Gündüz, Uludag University
- Investigators
- Gamze Ucan Gündüz, MD, Principal investigator, Uludag University, Department of OphthalmologySelim Doganay, MD, Principal investigator, Uludag University, Department of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07330713
- Sponsor's protocol ID
- 2019-21/36
- Acronym
- PRP-NAION
- Status last verified
- Dec 2025
- First submitted
- 28 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet-Rich Plasma for Acute Nonarteritic Anterior Ischemic Optic Neuropathy: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07330713
- Acronym / sponsor ID
- PRP-NAION / 2019-21/36
- Keywords
- nonarteritic anterior ischemic optic neuropathy, platelet-rich plasma, subtenon injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| PRP Treatment Group | Experimental | Biological: Autologous Platelet-Rich Plasma (PRP)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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Biological | PRP Treatment Group |
Primary outcome
Change in Best-Corrected Visual Acuity (BCVA)
Time frame: Baseline (Week 0) to Week 16
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.
2 secondary outcomes
Change in Visual Field Mean Deviation (MD) and Visual Field Index (VFI)
Time frame: Baseline (Week 0) to Week 16
Change in Peripapillary Retinal Nerve Fiber Layer (RNFL) Thickness
Time frame: Baseline (Week 0) to Week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gamze Ucan Gündüz, MD principal investigator
Uludag University, Department of Ophthalmology
Selim Doganay, MD principal investigator
Uludag University, Department of Ophthalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Platelet-Rich Plasma (PRP) in people with Nonarteritic Anterior Ischemic Optic Neuropathy, run by Uludag University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Best-Corrected Visual Acuity (BCVA) (time frame: Baseline (Week 0) to Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.