Treatment of persistent corneal epithelial defect by autologous serum application.
K Tsubota, E Goto, S Shimmura...
https://pubmed.ncbi.nlm.nih.gov/10519596Actively Recruiting
Led by Universidad Autonoma de Nuevo Leon · Updated on 2026-05-06
54
Participants Needed
1
Research Sites
N/A
Total Duration
U
Universidad Autonoma de Nuevo Leon
Lead Sponsor
H
Hospital Universitario Dr. Jose E. Gonzalez
Collaborating Sponsor
This research aims to compare different treatments for persistent epithelial defects (PED), which are corneal ulcers that do not heal within two weeks despite standard care. These ulcers result from missing substances in tears that normally help corneal healing, and the condition can worsen in diseases like diabetes. The study will evaluate whether autologous platelet-rich plasma (PRP) with a bandage contact lens heals PED faster than preservative-free lubricant with a bandage contact lens or eye patch with ocular lubricant ointment. Participants will be randomly assigned to one of three treatment groups: PRP eye drops with a bandage contact lens every 1 to 3 hours, preservative-free lubricant eye drops with a bandage contact lens every 1 to 3 hours, or an eye patch with ocular lubricant ointment applied every 24 hours. Treatments will continue until the corneal defect fully heals. If the ulcer worsens to corneal thinning or perforation, appropriate medical care will be provided. During the study, healing time will be closely monitored with assessments up to three months, including corneal sensitivity, visual acuity, ocular pain, surface symptoms, and quality of life. Researchers will also track adverse events, recurrences, and treatment failures. Weekly evaluations or sooner if needed will help measure progress, ensuring participant safety and thorough monitoring throughout the treatment period.
CONDITIONS
Autologous Platelet-rich Plasma in the Treatment of Persistent Epithelial Defects
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 months or until complete defect closure
Participants receive one of three treatments: bandage contact lens plus autologous platelet-rich plasma eye drops every 1 to 3 hours, bandage contact lens plus preservative-free lubricant eye drops every 1 to 3 hours, or eye patch plus ocular lubricant ointment every 24 hours. Treatment continues until complete healing of the corneal epithelial defect.
Weekly visits or sooner if needed
Duration - Up to 3 months after defect closure
Participants are monitored for adverse events, recurrences, and treatment failure for up to three months after defect closure.
Visits as needed based on participant condition
Total: 1 location
1
Departamento de Oftalmologia, Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, Mexico, 64460
Actively Recruiting
K
Karim Mohamed-Noriega, M.D.
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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