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

Corneal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02344732
• Other study ID #: NMRR-13-449-15617
• Status: Completed
• Phase: N/A
• First received: January 8, 2015
• Last updated: January 22, 2015
• Start date: October 2013
• Est. completion date: October 2014

Study information

• Verified date: January 2015
• Source: University of Science Malaysia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: National Medical Research Register
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Corneal Diseases

Intervention

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

• Homatropine 2% eye drops thrice daily

• Oxygen gas

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Science Malaysia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean corneal epithelial wound healing time (in days)		1 to 7 days	No
Secondary	Age of subject as a factor influencing wound healing time		1-7 days	No
Secondary	Glycemic control of subject (measured by glycated hemoglobin, HbA1c)		1-7 days	No
Secondary	Duration of surgery and its influence on wound healing time		1-7 days	No
Secondary	Duration of diabetes mellitus (measured in years) and its influence on wound healing time		1-7 days	No