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.
Age range
18 Years
Sex
ALL
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A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Change in corneal staining
Timeframe: from the beginning of the treatment and every 4 weeks until week 12.
Change in corneal sensitivity
Timeframe: from the beginning of the treatment and every 4 weeks until week 12.
Tear break-up time (TBUT)
Timeframe: from the beginning of the treatment and every 4 weeks until week 12.
Ocular Surface Disease Index (OSDI)
Timeframe: from the beginning of the treatment and every 4 weeks until week 12.
Tear osmolarity.
Timeframe: from the beginning of the treatment and every 4 weeks until week 12.
Schirmer test with anesthesia
Timeframe: from the beginning of the treatment and every 4 weeks until week 12.
Quality of life questionnaire (National Eye Institute Visual Function Questionnaire-25)
Timeframe: from the beginning of the treatment and every 4 weeks until week 12.
Karim Mohamed-Noriega, M.D.
Best corrected visual acuity
Timeframe: from the beginning of the treatment and every 4 weeks until week 12.
Frequency of adverse events.
Timeframe: from the beginning of the treatment and every 4 weeks until week 12.