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

Sponsor

Universiti Sains Malaysia (Other)

Overall Status

Completed

CT.gov ID

NCT02344732

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Corneal Diseases	Drug: Dexamethasone 0.1%, Neomycin Sulfate and Polymyxin B Sulfate topical eye drops four times daily Drug: Homatropine 2% eye drops thrice daily Drug: Oxygen gas	N/A

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)

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2013

Actual Primary Completion Date :

Oct 1, 2014

Actual Study Completion Date :

Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard Group topical Maxitrol™ six-hourly and homatropine 2% six-hourly	Drug: Dexamethasone 0.1%, Neomycin Sulfate and Polymyxin B Sulfate topical eye drops four times daily Other Names: Maxitrol Drug: Homatropine 2% eye drops thrice daily
Experimental: Oxygen Group 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	Drug: Dexamethasone 0.1%, Neomycin Sulfate and Polymyxin B Sulfate topical eye drops four times daily Other Names: Maxitrol Drug: Homatropine 2% eye drops thrice daily Drug: Oxygen gas

Arm

Intervention/Treatment

Active Comparator: Standard Group

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

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

Other Names:

Maxitrol

Drug: Homatropine 2% eye drops thrice daily

Experimental: Oxygen Group

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

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

Other Names:

Maxitrol

Drug: Homatropine 2% eye drops thrice daily

Drug: Oxygen gas

Outcome Measures

Primary Outcome Measures

Mean corneal epithelial wound healing time (in days) [1 to 7 days]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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).