Effect of Systemic Oxygen on Corneal Epithelial Wound Healing in Diabetic Patients Undergoing Pars Plana Vitrectomy
- Conditions
- Corneal Diseases
- Interventions
- Registration Number
- NCT02344732
- Lead Sponsor
- Universiti Sains Malaysia
- 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 Description
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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- diabetic patients aged 18 years and above planned for pars plana vitrectomy that required intra-operative corneal epithelial debridement to allow better surgical visualisation of the fundus were recruited within the study duration
- pre-existing ocular surface or corneal disease, recent eye surgery within one month from the vitrectomy, glaucoma and if the patients have any contraindications to oxygen therapy (e.g. chronic obstructive pulmonary disease).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard Group Dexamethasone 0.1%, Neomycin Sulfate and Polymyxin B Sulfate topical eye drops four times daily topical Maxitrol™ six-hourly and homatropine 2% six-hourly Oxygen Group Dexamethasone 0.1%, Neomycin Sulfate and Polymyxin B Sulfate topical eye drops four times daily standard medical treatment of topical Maxitrol™ six-hourly and homatropine 2% six-hourly, plus systemic oxygen via simple face mask at 10 litres/min for one hour, in 12-hourly sessions for 3 days Oxygen Group Homatropine 2% eye drops thrice daily standard medical treatment of topical Maxitrol™ six-hourly and homatropine 2% six-hourly, plus systemic oxygen via simple face mask at 10 litres/min for one hour, in 12-hourly sessions for 3 days Oxygen Group Oxygen gas standard medical treatment of topical Maxitrol™ six-hourly and homatropine 2% six-hourly, plus systemic oxygen via simple face mask at 10 litres/min for one hour, in 12-hourly sessions for 3 days Standard Group Homatropine 2% eye drops thrice daily topical Maxitrol™ six-hourly and homatropine 2% six-hourly
- Primary Outcome Measures
Name Time Method Mean corneal epithelial wound healing time (in days) 1 to 7 days
- Secondary Outcome Measures
Name Time Method Age of subject as a factor influencing wound healing time 1-7 days Glycemic control of subject (measured by glycated hemoglobin, HbA1c) 1-7 days Duration of surgery and its influence on wound healing time 1-7 days Duration of diabetes mellitus (measured in years) and its influence on wound healing time 1-7 days