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
Study type: Interventional
Phase: Phase 1

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
    

Detailed description: 
      Purpose: To evaluate the treatment effect of autologous serum eye drops for promoting corneal
      epithelium wound healing in patients receiving pars plana vitrectomy (PPV) for diabetic
      retinopathy and penetrating keratoplasty. Background: During PPV for diabetic retinopathy
      retinopathy and penetrating keratoplasty, removal of the edematous corneal epithelial layer
      was usually required in order to obtain a better surgical view or enhance the postoperative
      epithelial wound healing process. However, delayed epithelial healing was frequently found in
      these patients after surgeries. In addition, corneal epithelial defect is also frequent found
      in diabetic patients after PPV even corneal epithelial debridement is not performed during
      the operation. Autologous serum, the fluid component of full blood after blood clotting,
      contains a large variety of growth factors, vitamins, and immunoglobulins. These
      epitheliotropic factors are thought to be responsible for the therapeutic effect of serum
      observed on ocular surface disorders. The effects of serum to promote epithelial wound
      healing have been well documented in cell culture system in a variety of epithelial cell
      types including corneal epithelial cells. Autologous serum eye drops have also been
      demonstrated to be beneficial in the treatment of persistent corneal epithelial defects. In
      this study, we planned a prospective study to determine the effectiveness of autologous serum
      tears as a primary treatment in corneal epithelial defect following vitrectomy in diabetic
      patients and penetrating keratoplasty.
    

Intervention name(s): autologous serum; Non-autologous serum
Intervention type(s): Other; Other
Intervention description(s): 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
Other intervention name(s): Autoserum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: autoserum; ocular surgery; corneal epithelium healing