Effect of Systemic Oxygen on Corneal Epithelial Wound Healing in Diabetic Patients Undergoing Pars Plana Vitrectomy
Primary Purpose
Corneal Diseases
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dexamethasone 0.1%, Neomycin Sulfate and Polymyxin B Sulfate topical eye drops four times daily
Homatropine 2% eye drops thrice daily
Oxygen gas
Sponsored by
About this trial
This is an interventional treatment trial for Corneal Diseases focused on measuring epithelium, cornea, diabetes, vitrectomy, oxygen
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard Group
Oxygen Group
Arm Description
topical Maxitrol™ six-hourly and homatropine 2% six-hourly
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
Outcomes
Primary Outcome Measures
Mean corneal epithelial wound healing time (in days)
Secondary Outcome Measures
Age of subject as a factor influencing wound healing time
Glycemic control of subject (measured by glycated hemoglobin, HbA1c)
Duration of surgery and its influence on wound healing time
Duration of diabetes mellitus (measured in years) and its influence on wound healing time
Full Information
NCT ID
NCT02344732
First Posted
January 8, 2015
Last Updated
January 22, 2015
Sponsor
Universiti Sains Malaysia
1. Study Identification
Unique Protocol Identification Number
NCT02344732
Brief Title
Effect of Systemic Oxygen on Corneal Epithelial Wound Healing in Diabetic Patients Undergoing Pars Plana Vitrectomy
Official Title
Effect of Systemic Oxygen on Corneal Epithelial Wound Healing in Diabetic Patients Undergoing Pars Plana Vitrectomy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Sains Malaysia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To compare the corneal epithelial defect healing time between diabetic patients receiving and not receiving supplementary oxygen after vitrectomy.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Diseases
Keywords
epithelium, cornea, diabetes, vitrectomy, oxygen
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Group
Arm Type
Active Comparator
Arm Description
topical Maxitrol™ six-hourly and homatropine 2% six-hourly
Arm Title
Oxygen Group
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Dexamethasone 0.1%, Neomycin Sulfate and Polymyxin B Sulfate topical eye drops four times daily
Other Intervention Name(s)
Maxitrol
Intervention Type
Drug
Intervention Name(s)
Homatropine 2% eye drops thrice daily
Intervention Type
Drug
Intervention Name(s)
Oxygen gas
Primary Outcome Measure Information:
Title
Mean corneal epithelial wound healing time (in days)
Time Frame
1 to 7 days
Secondary Outcome Measure Information:
Title
Age of subject as a factor influencing wound healing time
Time Frame
1-7 days
Title
Glycemic control of subject (measured by glycated hemoglobin, HbA1c)
Time Frame
1-7 days
Title
Duration of surgery and its influence on wound healing time
Time Frame
1-7 days
Title
Duration of diabetes mellitus (measured in years) and its influence on wound healing time
Time Frame
1-7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wee-Min Teh, MD
Organizational Affiliation
Universiti Sains Malaysia
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Effect of Systemic Oxygen on Corneal Epithelial Wound Healing in Diabetic Patients Undergoing Pars Plana Vitrectomy
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