NCT02750098

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
Completed

Started May 2016

Typical duration for not_applicable diabetes-mellitus

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 25, 2016

Completed
6 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

April 25, 2016

Status Verified

April 1, 2016

Enrollment Period

1.6 years

First QC Date

April 11, 2016

Last Update Submit

April 20, 2016

Conditions

Diabetes Mellitus

Keywords

Diabetes Mellitus, Cataract, Aqueous humor

Outcome Measures

Primary Outcomes (1)

  • Aqueous humor glucose concentration

    Day of cataract surgery

Secondary Outcomes (2)

  • Plasma glucose concentrations

    Day of cataract surgery

  • Hemoglobin A1c

    Perioperative month

Study Arms (1)

Diabetic patients

EXPERIMENTAL

Diabetic patients planned to undergo elective cataract surgery

Other: Glucose measurement

Interventions

Glucose measurementOTHER

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

Diabetic patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Diabetic patients planed for elective cataract surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes MellitusCataract

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesLens DiseasesEye Diseases

Central Study Contacts

Lior Lipsky, MD

CONTACT

972-52-7360416lior.lipsky@gmail.com

Irit Barequet, MD

CONTACT

ibarequet@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cornea and refractive surgery specialist

Study Record Dates

First Submitted

April 11, 2016

First Posted

April 25, 2016

Study Start

May 1, 2016

Primary Completion

December 1, 2017

Study Completion

March 1, 2018

Last Updated

April 25, 2016

Record last verified: 2016-04