An interventional study of PRP plus BCL and BCL plus PFL in Persistent Epithelial Defect, sponsored by Universidad Autonoma de Nuevo Leon. Recruiting at 1 site in Mexico. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by Universidad Autonoma de Nuevo Leon · Not applicable, Interventional, and Treatment
Persistent epithelial defects (PED) are corneal ulcers that do not heal within the first two weeks of treatment with artificial tears or ocular lubricant ointment. It is believed that this condition is the result of the loss of certain substances normally present in the tears that aid in the healing process of the cornea. When the eye is healthy, these ulcers typically heal rapidly. However, when there is an underlying disease such as diabetes, this healing process is altered and it takes longer for the ulcer to heal. Autologous platelet-rich plasma (PRP) is a substance that is obtained from the patient's own blood and it is believed this substance may replace those missing factors in the tears of patients with PED. The purpose of this investigation is to find out whether PRP combined with a bandage contact lens is better than preservative free lubricant combined with bandage contact lens or than eye patch with ocular lubricant ointment for the treatment of PED. Participants will be randomly assigned to one of the three groups and will get the treatment until the ulcer heals completely. We will count the days it takes for the PED to heal and based on that we will determine wich treatment is more effective (the treatment that takes the least days to heal will be considered the most effective). Since this disease is difficult to treat and doesn't have a gold standard treatment, usually the available treatments are not as good as we would like, therefore, the ulcer might progress even to perforation regardless of the treatment. In these cases, we will provide appropriate treatment for progressive corneal thinning and corneal perforation.
Persistent epithelial defects (PED) are corneal lesions that do not heal within the first two weeks of conventional treatment (i.e. preservative-free lubricant, bandage contact lens (BCL), ocular lubricant ointment, eye patching). These defects are the result of the loss of certain lacrimal factors that maintain the integrity and homeostasis of the corneal epithelium and ocular surface. Normally, PED heal rapidly in the healthy eye. However, underlying ocular surface pathology can slow down the healing process and contribute to the persistence of the epithelial defect. Hematopoietic derivatives such as autologous platelet-rich plasma (PRP) may replace these missing components and eventually lead to complete healing in a faster and more comfortable way for the patient. The objective of this study is to determine if PRP combined with BCL is more effective than preservative-free lubricant combined with BCL or than eye patch with ocular lubricant ointment for the treatment of PED. Participants will be randomly assigned to one of the three groups and treatment will be administered until achieving complete defect closure. The effectiveness of each treatment will be measured in terms of days taken to achieve complete closure. Since PED is a complex disease that is difficult to treat, the available treatments are not very effective, therefore, PED might progress even to perforation regardless of the treatment. In this last scenario, we will provide appropriate treatment for progressive corneal thinning and corneal perforation
Universidad Autonoma de Nuevo Leon is the lead sponsor of 53 studies on the registry; 12 are open to participants now.
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Patients with persistent epithelial defect and at least one of the following diagnoses:
Exclusion Criteria:
Patients diagnosed with:
Bandage contact lens (BCL) plus 1 autologous platelet-rich plasma (PRP) eye drop every 1 to 3 hours.
Combination Product: PRP plus BCL
Bandage contact lens (BCL) plus 1 preservative-free lubricant (PFL) eye drop every 1 to 3 hours.
Combination Product: BCL plus PFL
Eye patch plus ocular lubricant ointment every 24 hours.
Combination Product: Eye patch plus ocular lubricant ointment
Drug page: Platelet rich plasma
Bandage contact lens (BCL) plus 1 autologous platelet-rich plasma (PRP) eye drop every 1 to 3 hours.
Bandage contact lens (BCL) plus 1 preservative-free lubricant (PFL) eye drop every 1 to 3 hours.
Eye patch plus ocular lubricant ointment every 24 hours.
Persistent epithelial defect healing time.
Persistent epithelial defect healing time measured in days.
Time frame: From the first day of treatment until the date of complete defect closure, assessed up to 3 months.
Change in corneal sensitivity
Corneal sensitivity will be assessed with corneal esthesiometer Cochet-Bonnet.
Time frame: Change from baseline corneal sensitivity at the date of defect closure, up to 3 months.
Uncorrected visual acuity
Uncorrected visual acuity will be assessed using Snellen cards. Measurements will be converted to LogMar values for statistical analysis.
Time frame: Every week (or sooner, if needed) from date of randomization until the date of complete defect closure, up to 3 months.
Best corrected visual acuity
Best corrected visual acuity will be assessed using Snellen cards. Measurements will be converted to LogMar values for statistical analysis.
Time frame: Every week (or sooner, if needed) from date of randomization until the date of complete defect closure, up to 3 months.
Ocular pain
Ocular pain will be assessed using the Wong-Baker Faces Pain Rating Scale. The scale ranges from 0 (no pain) to 10 (maximum pain), and includes 6 faces (visual representation), numbers, and written descriptions that represent the level of pain. The first face represents a pain score of 0 and it reads "no hurt"; the second face represents a pain score of 2 and it reads "hurts little bit"; the third face represents a pain score of 4 and it reads "hurts little more"; the fourth face represents a pain score of 6 and it reads "hurts even more"; the fifth face represents a pain score of 8 and it reads "hurts whole lot"; the last face represents a pain score of 10 and it reads "hurst worst". Lower values represent a better outcome.
Time frame: Every week (or sooner, if needed) from date of randomization until the date of complete defect closure, up to 3 months.
Ocular surface symptoms
Ocular surface symptoms as assessed by the Symptom Assessment in Dry Eye (SANDE) questionnaire. The SANDE questionnaire consists of two questions presented in visual analog scale. The first question assesses the frequency of dry eye syndrome and the scale ranges from "rarely" to "all the time" on a 100 mm line. The second question assesses the severity of dry eye syndrome and the scale ranges from "very mild" to "very severe" on a 100 mm line. Patients are asked to place a mark on the line to represent the extent of their symptoms, then the location of the marks on each line are measured from left to right in mm. The SANDE score is calculated by multiplying the frequency value times the severity value and obtaining the square root. Lower scores represent a better outcome.
Time frame: Every week (or sooner, if needed) from date of randomization until the date of complete defect closure, up to 3 months.
Ocular surface symptoms
Ocular surface symptoms as 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.
Time frame: At date of randomization and at date of defect closure, up to 3 months.
Quality of life questionnaire
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.
Time frame: At date of randomization and at date of defect closure, up to 3 months.
Frequency of adverse events, recurrences and/or treatment failure
Frequency of adverse events, recurrences and/or treatment failure will be evaluated during the ophthalmic evaluation.
Time frame: These will be evaluated from the beginning of the treatment until three months after defect closure.
Plan to share: No
Started Aug 2018 (actual). Primary completion is estimated for Aug 2027, 108 months after the start.
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Studies of the drug tested here: Platelet rich plasma
Universidad Autonoma de Nuevo Leon