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Comparison of Aqueous and Plasma Glucose Level in Diabetic Patients

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. Identifier: NCT02750098
Recruitment Status : Unknown
Verified April 2016 by Prof. Irina Barequet, Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : April 25, 2016
Last Update Posted : April 25, 2016
Information provided by (Responsible Party):
Prof. Irina Barequet, Sheba Medical Center

Brief Summary:

Comparison of aqueous and plasma glucose level in diabetic patients

High glucose concentrations in aqueous humor are thought to be related of diabetic ocular injury, including cataract and diabetic keratopathy. The primary mechanisms are nonenzymatic glycation, oxidative stress and activation of polyol pathway. However, glucose concentrations in aqueous humor of diabetic patients was only examined in a few patients in the past.

This study will compare glucose concentration in blood plasma and aqueous humor in diabetic patients undergoing cataract surgery. Perioperative Hemoglobin A1c concentrations will also be examined. Correlation between these parameters will be analyzed.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Other: Glucose measurement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of Aqueous and Plasma Glucose Level in Diabetic Patients
Study Start Date : May 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
Drug Information available for: Dextrose

Arm Intervention/treatment
Experimental: Diabetic patients
Diabetic patients planned to undergo elective cataract surgery
Other: Glucose measurement
  1. Elective cataract surgery
  2. Blood glucose measurement - glucometer
  3. Aqueous humor glucose measurement - at beginning of cataract surgery - glucometer
  4. Perioperative Hemoglobin A1c level - blood laboratory test

Primary Outcome Measures :
  1. Aqueous humor glucose concentration [ Time Frame: Day of cataract surgery ]

Secondary Outcome Measures :
  1. Plasma glucose concentrations [ Time Frame: Day of cataract surgery ]
  2. Hemoglobin A1c [ Time Frame: Perioperative month ]

Information from the National Library of Medicine

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

Inclusion Criteria:

- Diabetic patients planed for elective cataract surgery

Exclusion Criteria:

  • s/p traumatic eye injury
  • past or current uveitis
  • patients using prescription eye drops except lubricants

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 identifier (NCT number): NCT02750098

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Contact: Lior Lipsky, MD 972-52-7360416
Contact: Irit Barequet, MD

Sponsors and Collaborators
Sheba Medical Center
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Responsible Party: Prof. Irina Barequet, Cornea and refractive surgery specialist, Sheba Medical Center Identifier: NCT02750098    
Other Study ID Numbers: 296416
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: April 25, 2016
Last Verified: April 2016
Keywords provided by Prof. Irina Barequet, Sheba Medical Center:
Diabetes Mellitus, Cataract, Aqueous humor
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases