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

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

Sponsors

Lead Sponsor: Universiti Sains Malaysia

Source 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)

Overall Status Completed
Start Date 2013-10-01
Completion Date 2014-10-01
Primary Completion Date 2014-10-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Mean corneal epithelial wound healing time (in days) 1 to 7 days
Secondary Outcome
Measure Time Frame
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
Enrollment 32
Condition
Intervention

Intervention Type: Drug

Intervention Name: Dexamethasone 0.1%, Neomycin Sulfate and Polymyxin B Sulfate topical eye drops four times daily

Other Name: Maxitrol

Intervention Type: Drug

Intervention Name: Homatropine 2% eye drops thrice daily

Intervention Type: Drug

Intervention Name: Oxygen gas

Arm Group Label: Oxygen Group

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).

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Wee-Min Teh, MD Principal Investigator Universiti Sains Malaysia
Verification Date

2015-01-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Universiti Sains Malaysia

Investigator Full Name: Teh Wee Min

Investigator Title: Dr

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Standard Group

Type: Active Comparator

Description: topical Maxitrol™ six-hourly and homatropine 2% six-hourly

Label: Oxygen Group

Type: Experimental

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

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Outcomes Assessor)

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