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

NCT02344732 | Completed

• 1 other identifier: NMRR-13-449-15617
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.To compare the corneal epithelial defect healing time between diabetic patients receiving and not receiving supplementary oxygen after vitrectomy.
2. 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.

Conditions

Corneal Diseases

Keywords

epithelium, cornea, diabetes, vitrectomy, oxygen

Outcome Measures

Primary Outcomes (1)

• Mean corneal epithelial wound healing time (in days)

  1 to 7 days

Secondary Outcomes (4)

• 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

Study Arms (2)

Standard Group

ACTIVE COMPARATOR

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; Drug: Homatropine 2% eye drops thrice daily

Oxygen Group

EXPERIMENTAL

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; Drug: Homatropine 2% eye drops thrice daily; Drug: Oxygen gas

Interventions

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

Also known as: Maxitrol

Oxygen Group; Standard Group

Homatropine 2% eye drops thrice daily DRUG

Oxygen Group; Standard Group

Oxygen gas DRUG

Oxygen Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

MeSH Terms

Conditions

Corneal Diseases; Diabetes Mellitus

Interventions

Dexamethasone; Neomycin; Maxitrol; homatropine; nitrox

Condition Hierarchy (Ancestors)

Eye Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Wee-Min Teh, MD

  Universiti Sains Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: January 8, 2015
• First Posted: January 26, 2015
• Study Start: October 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: January 26, 2015

Record last verified: 2015-01