Topical Autologous Serum Application for the Treatment of Corneal Epithelium Defect After Ocular Surgeries
Condition: Corneal Epithelial Defect; Diabetic Retinopathy; Penetrating Keratoplasty
MeSH terms: Diabetic Retinopathy
Intervention: autologous serum; Non-autologous serum
Intervention description: with postoperative 20% autologous serum diluted with preservative-free artificial tear application bi-hourly during waking hours; without postoperative 20% autologous serum diluted with preservative-free artificial tear application bi-hourly during waking hours
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 165.0
Sex: All
Minimum age: 20 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: autoserum; ocular surgery; corneal epithelium healing

Summary:

      Ophthalmology ,cornea Autologous serum has long been known to be effective to promote corneal
      epithelial wound healing in a variety of ocular surface disorders. However, its effectiveness
      for corneal epithelial defects due to pars plana vitrectomy (PPV) for diabetic retinopathy
      and penetrating keratoplasty has seldom been reported. In this study, we plan to perform a
      prospective study to determine the effectiveness of topical autologous serum as a primary
      treatment for corneal epithelial defect in patients undergoing vitrectomy for diabetic
      retinopathy and penetrating keratoplasty. All patients enrolled in this study have received
      corneal epithelial debridement at the end of the ocular surgeries, namely PPV for diabetic
      retinopathy and penetrating keratoplasty. The patients were grouped into two treatment
      groups. In the control group, the patients receive conventional postoperative eye drops
      including topical steroid, antibiotic and mydriatics. In the experimental group, the patients
      receive topical autologous serum eye drops in addition to conventional postoperative eye
      drops. The duration for cornea surface to completely re-epithelize, the incidence of corneal
      complications due to delayed surface re-epithelization (e.g. infectious corneal ulcer,
      corneal melting, sterile corneal ulcer, corneal neovascularization), and the incidence of
      recurrent epithelial break down after initial epithelization will be compared between these
      two groups. Patients undergoing PPV for diabetic retinopathy and penetrating keratoplasty
      will be compared separately
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients with proliferative diabetic retinopathy who's condition need to receive pars
             plana vitrectomy or patients who need to receive penetrating keratoplasty

        Exclusion Criteria:

          -  For PPV: ocular disease such as limbal stem cell Insufficiency , glaucoma,
             lagophthalmos

          -  For penetrating keratoplasty:ocular or systemic disease that would affect epithelial
             healing, such as severe dry eye, severe lid abnormalities, limbal stem cell
             deficiency, or corneal anesthesia