Clinical Trial: Effect of Systemic Oxygen on Corneal Epithelial Wound Healing in Diabetic Patients Undergoing Pars Plana Vitrectomy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effect of Systemic Oxygen on Corneal Epithelial Wound Healing in Diabetic Patients Undergoing Pars Plana Vitrectomy

Brief Summary:

  1. To compare the corneal epithelial defect healing time between diabetic patients receiving and not receiving supplementary oxygen after vitrectomy.
  2. To determine whether factors such as age, duration of diabetes, duration of surgery and level of glycemic control have any influence on corneal epithelial wound healing time in diabetic patients receiving and not receiving supplementary oxygen post-vitrectomy.

Detailed Summary: This study aims to determine whether systemic oxygen therapy delivered through face mask would have beneficial effects on the healing of corneal epithelial wound in post-vitrectomy diabetic patients. It will be a prospective, randomised interventional clinical study conducted on diabetic patients indicated for vitrectomy. Rationale of this study is to see if systemic oxygen delivered via face mask will hasten the resolution of corneal epithelial defects, which may either be iatrogenic (surgically-induced intra-operatively to enable clearer visualisation for the surgeon) or spontaneous (due to corneal epithelial fragility which is commoner in diabetics)
Sponsor: University of Science Malaysia

Current Primary Outcome: Mean corneal epithelial wound healing time (in days) [ Time Frame: 1 to 7 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Age of subject as a factor influencing wound healing time [ Time Frame: 1-7 days ]
  • Glycemic control of subject (measured by glycated hemoglobin, HbA1c) [ Time Frame: 1-7 days ]
  • Duration of surgery and its influence on wound healing time [ Time Frame: 1-7 days ]
  • Duration of diabetes mellitus (measured in years) and its influence on wound healing time [ Time Frame: 1-7 days ]


Original Secondary Outcome: Same as current

Information By: University of Science Malaysia

Dates:
Date Received: January 8, 2015
Date Started: October 2013
Date Completion:
Last Updated: January 22, 2015
Last Verified: January 2015