Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 25 of 61 for:    Neomycin sulfate

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02344732
Recruitment Status : Completed
First Posted : January 26, 2015
Last Update Posted : January 26, 2015
Sponsor:
Information provided by (Responsible Party):
Teh Wee Min, University of Science 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.

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 Not Applicable

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)

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : October 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Maxitrol

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 Name: 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 Name: Maxitrol

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



Primary Outcome Measures :
  1. Mean corneal epithelial wound healing time (in days) [ Time Frame: 1 to 7 days ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02344732


Sponsors and Collaborators
University of Science Malaysia
Investigators
Layout table for investigator information
Principal Investigator: Wee-Min Teh, MD University of Science Malaysia

Layout table for additonal information
Responsible Party: Teh Wee Min, Dr, University of Science Malaysia
ClinicalTrials.gov Identifier: NCT02344732     History of Changes
Other Study ID Numbers: NMRR-13-449-15617
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: January 26, 2015
Last Verified: January 2015

Keywords provided by Teh Wee Min, University of Science Malaysia:
epithelium, cornea, diabetes, vitrectomy, oxygen

Additional relevant MeSH terms:
Layout table for MeSH terms
Neomycin
Dexamethasone, neomycin, polymyxin B drug combination
Corneal Diseases
Eye Diseases
Dexamethasone
Homatropine
Ophthalmic Solutions
Polymyxins
Polymyxin B
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Pharmaceutical Solutions
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Parasympatholytics