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Completed

NCT Number: NCT02344732

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

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.

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Key information

Conditions

Corneal Diseases Diabetes Mellitus Endocrine System Diseases Eye Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Drug

Other names: Maxitrol

Homatropine 2% eye drops thrice daily

Drug

Oxygen gas

Drug

Primary outcomes

  1. Mean corneal epithelial wound healing time (in days)

    Time frame: 1 to 7 days

Secondary outcomes

  1. Age of subject as a factor influencing wound healing time

    Time frame: 1-7 days

  2. Glycemic control of subject (measured by glycated hemoglobin, HbA1c)

    Time frame: 1-7 days

  3. Duration of surgery and its influence on wound healing time

    Time frame: 1-7 days

  4. Duration of diabetes mellitus (measured in years) and its influence on wound healing time

    Time frame: 1-7 days

Sponsors and collaborators

Lead sponsor

Universiti Sains Malaysia

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 26, 2015
Registry last updated
Jan 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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