Neurotrophic KeratopathyNCT04604834
Autologous Platelet-rich Plasma (APRP) in the Treatment of Neurotrophic Keratopathy
A study testing PFAT first and APRP first in people with Neurotrophic Keratopathy, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.
Trial summary
Neurotrophic keratopathy (NK) is a condition where the cornea loses its capacity to feel pain and touch. This causes a decrease in the production of certain substances that maintain the integrity of the corneal epithelium (the most superficial layer that covers the cornea). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurotrophic Keratopathy
- What is being tested?
- PFAT first and APRP first
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteMexico
- Study dates
- 1 Nov 2020to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with:
- Neurotrophic keratopathy diagnosed by esthesiometry (defined as central corneal sensitivity ≤ 3cm using Cochet-Bonnet aesthesiometer).
- Corneal erosions.
- Neurotrophic keratopathy secondary to: diabetes mellitus, herpetic keratitis, microbial keratitis sequelae (bacteria, Acanthamoeba, fungi, herpes), limbal stem cell deficiency, chemical or thermic burn sequelae at least 3 months after the accident, ocular trauma with penetrating wound fixed at least 3 months before the trial, surgery carried out at least 3 month before the trial (including keratoplasty, laser in situ keratomileusis, phacoemulsification cataract surgery, extracapsular cataract extraction), adenoviral keratoconjunctivitis resolved at least 3 months the trial.
Who cannot join
- Patients diagnosed with:
- Other ocular surface pathology presenting with corneal erosions but without corneal hyposensitivity.
- Corneal epithelial defect with or without corneal hyposensitivity.
- Pregnant women, homeless, migrants.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Departamento de Oftalmologia, Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, 64460
Karim Mohamed-Noriega, M.D., +52 81 83469259, karim.mohamednrg@uanl.edu.mx, drkmohamed1@gmail.com
Karim Mohamed-Noriega, M.D.
About this study
Neurotrophic keratopathy (NK) is a condition where the cornea loses its capacity to feel pain and touch. This causes a decrease in the production of certain substances that maintain the integrity of the corneal epithelium (the most superficial layer that covers the cornea). As a result, the cornea cannot heal wounds as fast as it should and this could lead to corneal breakdown. This disease is chronic, meaning that it does not resolve quickly, and the treatments commonly used to manage it (such as artificial tears) take a long time to work, which makes it hard to follow doctor's orders. Autologous platelet-rich plasma is a substance that is obtained from the patient's own blood and it may contain those components that are missing in the tears of people with NK. The purpose of this experiment is to find out whether APRP+PFAT is better than APRP alone or PFAT alone in the treatment of NK. Participants will be randomly assigned to one of three groups: one group will start with APRP, other will start with PFAT and another with PFAT+APRP. The participants will receive each treatment for four weeks, and then the subjects will switch groups and use them for four weeks each (12 weeks total). Investigators will evaluate different parameters that will let us know if your condition is improving. These evaluations will be carried out every four weeks from the start to the end of the protocol. In case of intolerance or adverse effects, treatment will be discontinued.
Read the detailed description
Neurotrophic keratopathy is characterized by impaired corneal sensitivity that results in a decrease in neurotrophic and epitheliotropic factors that are essential for proper corneal epithelial and ocular surface function. This neurotrophic state halts mitosis and epithelial turnover, which in turn slow down wound healing and lead to epithelial breakdown. Due to the chronicity of this disease, treatment adherence becomes a problem for patients; furthermore, results with conventional treatments such as preservative-free artificial tears are discouraging. Hematopoietic derivatives such as APRP may replace those missing neurotrophic factors and lead to epithelial healing in a faster and more comfortable manner. The objective of this study is to determine if APRP+PFAT is better than autologous platelet-rich plasma (APRP) or preservative-free artificial tears (PFAT) in the treatment of neurotrophic keratopathy. Subjects will be randomly assigned to one of three groups and treatment will be administered for four weeks. After this period, subjects will switch groups and receive the new treatment for four more weeks (cross-over). After this second period is completed, subjects will receive the last treatment for four more weeks. A thorough ophthalmologic evaluation will be performed before starting treatment and every four weeks until completion. Treatment will be discontinued if there are adverse effects or treatment intolerance.
- Conditions
- Neurotrophic Keratopathy
- Being tested
- PFAT first, APRP first
- Keywords
- Autologous PRP, Neurotrophic keratopathy, Autologous platelet-rich plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFAT firstOther
Week 1 to week 4: one eyedrop of PFAT (preservative-free artificial tears) every 2 hours. Week 5 to week 8: one eyedrop of APRP (autologous plasma rich platelet) every 2 hours. Week 9 to week 12: one eyedrop of PFAT and APRP every 2 hours.
APRP firstOther
Week 1 to week 4: one eyedrop of APRP every 2 hours. Week 5 to week 8: one eyedrop of PFAT every 2 hours. Week 9 to week 12: one eyedrop of PFAT and APRP every 2 hours.
| Study group | Role | What they receive |
|---|---|---|
| PFAT first | Experimental | 1 eyedrop of PFAT every 2 hours in study eye. Receives: Other: PFAT first |
| APRP first | Experimental | 1 eyedrop of APRP every 2 hours in study eye. Receives: Other: APRP first |
| APRP+PFAT first | Experimental | 1 eyedrop of PFAT and APRP every 2 hours in study eye. Receives: Other: PFAT first; Other: APRP first |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in corneal staining
Change in corneal epithelial damage will be measured using corneal staining with fluorescein dye and the NEI grading scale.
Measured: from the beginning of the treatment and every 4 weeks until week 12.
Change in corneal sensitivity
Change in corneal sensitivity will be measured using Cochet-Bonnet aesthesiometer.
Measured: from the beginning of the treatment and every 4 weeks until week 12.
Tear break-up time (TBUT)
Tear break up time will be assessed using fluorescein dye, measuring break up time in seconds. A result >10 seconds will be considered normal, a result <10 seconds will be considered pathological.
Measured: from the beginning of the treatment and every 4 weeks until week 12.
Ocular Surface Disease Index (OSDI)
Ocular surface symptoms will be assessed by the Ocular Surface Disease Index (OSDI). The OSDI questionnaire consists of 12 questions that assess dry eye symptoms and their effects on vision related function. The questionnaire is divided in 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients are asked to rate their responses on a 0 to 4 scale where 0 represents "none of the time", 1 "some of the time", 2 "half of the time", 3 "most of the time", and 4 "all of the time". The total score is calculated using the following formula: ([sum of scores for all questions answered x 100] / [total number of questions answered x 4]). Lower scores represent a better outcome.
Measured: from the beginning of the treatment and every 4 weeks until week 12.
Tear osmolarity.
Tear osmolarity is one of tear inflammation biomarkers. Tear osmolarity will be performed with Tear Lab Osmolarity System, a result of 308 milliosmol (mOsm)/L or higher indicates pathological result.
Measured: from the beginning of the treatment and every 4 weeks until week 12.
Schirmer test with anesthesia
Tear production will be measured by Schirmer test with anesthesia. The Schirmer test with anesthesia >15 mm is consider normal.
Measured: from the beginning of the treatment and every 4 weeks until week 12.
Quality of life questionnaire (National Eye Institute Visual Function Questionnaire-25)
Quality of life as assessed by the National Eye Institute Visual Function Questionnaire (NEI VFQ-25). The NEI VFQ-25 questionnaire consists of 25 questions that assess the effect of visual impairment on the patient's quality of life. The 25-item questionnaire gives a score on a scale of 0 to 100, where 0 is the worst score and 100 is the best score. Higher scores represent a better outcome.
Measured: from the beginning of the treatment and every 4 weeks until week 12.
Best corrected visual acuity
Best corrected visual acuity will be assessed using Snellen cards. Measurements will be converted to LogMar values for statistical analysis.
Measured: from the beginning of the treatment and every 4 weeks until week 12.
Frequency of adverse events.
Frequency of adverse events will assessed for security and effectiveness of the treatment during the ophthalmic evaluation.
Measured: from the beginning of the treatment and every 4 weeks until week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start1 Nov 2020
- Primary completionNov 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurotrophic KeratopathyStudies 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
- Crossover
- Model description
- Subjects will be selected based on inclusion and exclusion criteria. A thorough ophthalmologic evaluation will be carried out before starting any treatment (baseline). Subjects will be randomly assigned to one of the treatment groups and receive the corresponding treatment for 4 weeks. At the end of week 4, subjects will switch treatment groups (crossover) and receive the new treatment for 4 more weeks. At the end of week 8, subjects will start the last treatment for 4 more weeks. Ophthalmologic evaluations will be performed every 4 weeks.
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Nuevo Leon
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Dr. Jose E. Gonzalez
- Responsible party
- Principal investigator, Karim Mohamed-Noriega, Universidad Autonoma de Nuevo Leon
- Investigators
- Karim Mohamed-Noriega, M.D., Principal investigator, Hospital Universitario Dr. Jose E. Gonzalez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04604834
- Sponsor's protocol ID
- OF14-004
- Status last verified
- May 2026
- First submitted
- 15 Oct 2020
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Platelet-rich Plasma (APRP) in the Treatment of Neurotrophic Keratopathy
- ClinicalTrials.gov ID
- NCT04604834
- Acronym / sponsor ID
- OF14-004
- Conditions
- Neurotrophic Keratopathy
- Keywords
- Autologous PRP, Neurotrophic keratopathy, Autologous platelet-rich plasma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Universidad Autonoma de Nuevo LeonUniversity, hospital or other
- Collaborators
- Hospital Universitario Dr. Jose E. Gonzalez
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 27 Oct 2020 (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.
Neurotrophic keratopathy (NK) is a condition where the cornea loses its capacity to feel pain and touch. This causes a decrease in the production of certain substances that maintain the integrity of the corneal epithelium (the most superficial layer that covers the cornea). As a result, the cornea cannot heal wounds as fast as it should and this could lead to corneal breakdown. This disease is chronic, meaning that it does not resolve quickly, and the treatments commonly used to manage it (such as artificial tears) take a long time to work, which makes it hard to follow doctor's orders. Autologous platelet-rich plasma is a substance that is obtained from the patient's own blood and it may contain those components that are missing in the tears of people with NK. The purpose of this experiment is to find out whether APRP+PFAT is better than APRP alone or PFAT alone in the treatment of NK. Participants will be randomly assigned to one of three groups: one group will start with APRP, other will start with PFAT and another with PFAT+APRP. The participants will receive each treatment for four weeks, and then the subjects will switch groups and use them for four weeks each (12 weeks total). Investigators will evaluate different parameters that will let us know if your condition is improving. These evaluations will be carried out every four weeks from the start to the end of the protocol. In case of intolerance or adverse effects, treatment will be discontinued.
Detailed description
Neurotrophic keratopathy is characterized by impaired corneal sensitivity that results in a decrease in neurotrophic and epitheliotropic factors that are essential for proper corneal epithelial and ocular surface function. This neurotrophic state halts mitosis and epithelial turnover, which in turn slow down wound healing and lead to epithelial breakdown. Due to the chronicity of this disease, treatment adherence becomes a problem for patients; furthermore, results with conventional treatments such as preservative-free artificial tears are discouraging. Hematopoietic derivatives such as APRP may replace those missing neurotrophic factors and lead to epithelial healing in a faster and more comfortable manner. The objective of this study is to determine if APRP+PFAT is better than autologous platelet-rich plasma (APRP) or preservative-free artificial tears (PFAT) in the treatment of neurotrophic keratopathy. Subjects will be randomly assigned to one of three groups and treatment will be administered for four weeks. After this period, subjects will switch groups and receive the new treatment for four more weeks (cross-over). After this second period is completed, subjects will receive the last treatment for four more weeks. A thorough ophthalmologic evaluation will be performed before starting treatment and every four weeks until completion. Treatment will be discontinued if there are adverse effects or treatment intolerance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Subjects will be selected based on inclusion and exclusion criteria. A thorough ophthalmologic evaluation will be carried out before starting any treatment (baseline). Subjects will be randomly assigned to one of the treatment groups and receive the corresponding treatment for 4 weeks. At the end of week 4, subjects will switch treatment groups (crossover) and receive the new treatment for 4 more weeks. At the end of week 8, subjects will start the last treatment for 4 more weeks. Ophthalmologic evaluations will be performed every 4 weeks.
| Arm | Type | Receives |
|---|---|---|
| PFAT first | Experimental | Other: PFAT first1 eyedrop of PFAT every 2 hours in study eye. |
| APRP first | Experimental | Other: APRP first1 eyedrop of APRP every 2 hours in study eye. |
| APRP+PFAT first | Experimental | Other: PFAT first, Other: APRP first1 eyedrop of PFAT and APRP every 2 hours in study eye. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with:
Key exclusion criteria (4 listed)
- Patients diagnosed with:
- Pregnant women, homeless, migrants.
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 |
|---|---|---|
| PFAT firstWeek 1 to week 4: one eyedrop of PFAT (preservative-free artificial tears) every 2 hours. Week 5 to week 8: one eyedrop of APRP (autologous plasma rich platelet) every 2 hours. Week 9 to week 12: one eyedrop of PFAT and APRP every 2 hours. | Other | APRP+PFAT first, PFAT first |
| APRP firstWeek 1 to week 4: one eyedrop of APRP every 2 hours. Week 5 to week 8: one eyedrop of PFAT every 2 hours. Week 9 to week 12: one eyedrop of PFAT and APRP every 2 hours. | Other | APRP first, APRP+PFAT first |
Primary outcome
Change in corneal staining
Time frame: from the beginning of the treatment and every 4 weeks until week 12.
Change in corneal epithelial damage will be measured using corneal staining with fluorescein dye and the NEI grading scale.
Change in corneal sensitivity
Time frame: from the beginning of the treatment and every 4 weeks until week 12.
Change in corneal sensitivity will be measured using Cochet-Bonnet aesthesiometer.
Tear break-up time (TBUT)
Time frame: from the beginning of the treatment and every 4 weeks until week 12.
Tear break up time will be assessed using fluorescein dye, measuring break up time in seconds. A result >10 seconds will be considered normal, a result <10 seconds will be considered pathological.
Ocular Surface Disease Index (OSDI)
Time frame: from the beginning of the treatment and every 4 weeks until week 12.
Ocular surface symptoms will be assessed by the Ocular Surface Disease Index (OSDI). The OSDI questionnaire consists of 12 questions that assess dry eye symptoms and their effects on vision related function. The questionnaire is divided in 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients are asked to rate their responses on a 0 to 4 scale where 0 represents "none of the time", 1 "some of the time", 2 "half of the time", 3 "most of the time", and 4 "all of the time". The total score is calculated using the following formula: ([sum of scores for all questions answered x 100] / [total number of questions answered x 4]). Lower scores represent a better outcome.
Tear osmolarity.
Time frame: from the beginning of the treatment and every 4 weeks until week 12.
Tear osmolarity is one of tear inflammation biomarkers. Tear osmolarity will be performed with Tear Lab Osmolarity System, a result of 308 milliosmol (mOsm)/L or higher indicates pathological result.
Schirmer test with anesthesia
Time frame: from the beginning of the treatment and every 4 weeks until week 12.
Tear production will be measured by Schirmer test with anesthesia. The Schirmer test with anesthesia >15 mm is consider normal.
Quality of life questionnaire (National Eye Institute Visual Function Questionnaire-25)
Time frame: from the beginning of the treatment and every 4 weeks until week 12.
Quality of life as assessed by the National Eye Institute Visual Function Questionnaire (NEI VFQ-25). The NEI VFQ-25 questionnaire consists of 25 questions that assess the effect of visual impairment on the patient's quality of life. The 25-item questionnaire gives a score on a scale of 0 to 100, where 0 is the worst score and 100 is the best score. Higher scores represent a better outcome.
Best corrected visual acuity
Time frame: from the beginning of the treatment and every 4 weeks until week 12.
Best corrected visual acuity will be assessed using Snellen cards. Measurements will be converted to LogMar values for statistical analysis.
Frequency of adverse events.
Time frame: from the beginning of the treatment and every 4 weeks until week 12.
Frequency of adverse events will assessed for security and effectiveness of the treatment during the ophthalmic evaluation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
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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.
Karim Mohamed-Noriega, M.D. principal investigator
Hospital Universitario Dr. Jose E. Gonzalez
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PFAT first and APRP first in people with Neurotrophic Keratopathy, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.
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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 6 May 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 Mexico. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karim Mohamed-Noriega, M.D. (+52 8183469259, karim.mohamednrg@uanl.edu.mx,drkmohamed1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in corneal staining (time frame: from the beginning of the treatment and every 4 weeks until week 12.). The study lists 9 primary outcomes in all. 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 6 May 2026.