Autologous Platelet-rich Plasma (APRP) in the Treatment of Neurotrophic Keratopathy

Condition(s) studied

Investigational drug(s) / intervention(s)

PFAT first: 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 first: 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 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). 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.

Eligibility

Primary outcome measure(s)

• Change in corneal staining — 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 — 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) — 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) — 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. — 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 — 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) — 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 — 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. — 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.

Trial sites (1)

More Universidad Autonoma de Nuevo Leon trials in Mexico