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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
Universiti Sains Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Corneal Diseases focused on measuring epithelium, cornea, diabetes, vitrectomy, oxygen

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 8, 2015
    Last Updated
    January 22, 2015
    Sponsor
    Universiti Sains Malaysia
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    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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