Retinal Function in Relation to Transient or Chronic Challenges to Retinal Metabolism

March 10, 2015 updated by: Oliver Niels Klefter, Glostrup University Hospital, Copenhagen
The aim of the study is to investigate how the retina adapts to different metabolic challenges, e.g. chronic systemic hypoxia, hyperglycemia, special training conditions or diets as well as transient changes in the content of oxygen and glucose in the blood.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Oliver Klefter, MD
  • Phone Number: +45 38 63 48 18

Study Locations

  • Denmark
      • Glostrup, Denmark, 2600
        • Recruiting
        • Department of Ophthalmology, Glostrup University Hospital
        • Contact:
          • Oliver Klefter, MD
          • Phone Number: +45 38 63 48 18
        • Contact:
          • Michael Larsen, Professor, DMSci

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Healthy individuals

Inclusion Criteria:

  • Healthy volunteers.
  • No known systemic or ocular disease.

Exclusion Criteria:

  • Any systemic or ocular disease.

Patients with diabetes

Inclusion criteria:

  • Diabetes mellitus
  • No intraocular disease other than conditions attributable to diabetes.

Exclusion criteria:

  • Intraocular disease other than conditions attributable to diabetes.
  • Systemic conditions which might contraindicate hyperoxic stimulation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy
Healthy study participanats
Other: Hyperoxia
Other Names:
  • Hyperoxia is achieved by short-term pure oxygen breathing.
Other: Glucose
Other Names:
  • Standardised oral glucose load.
Experimental: Diabetes
Patients with diabetes
Other: Hyperoxia
Other Names:
  • Hyperoxia is achieved by short-term pure oxygen breathing.
Other: Glucose
Other Names:
  • Standardised oral glucose load.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retinal vessel diameters during hyperoxia
Time Frame: Before hyperoxia, after 15 minutes of hyperoxia, 30 minutes after ending hyperoxia
Measurement of retinal vessel diameters before, during and after hyperoxic stimulation.
Before hyperoxia, after 15 minutes of hyperoxia, 30 minutes after ending hyperoxia
Retinal perfusion velocities during hyperoxia
Time Frame: Before hyperoxia, after 15 minutes of hyperoxia, 30 minutes after ending hyperoxia
Measurement of retinal perfusion velocities before, during and after hyperoxic stimulation.
Before hyperoxia, after 15 minutes of hyperoxia, 30 minutes after ending hyperoxia
Retinal oximetry during hyperoxia
Time Frame: Before hyperoxia, after 15 minutes of hyperoxia, 30 minutes after ending hyperoxia
Measurement of retinal oximetry status before, during and after hyperoxic stimulation.
Before hyperoxia, after 15 minutes of hyperoxia, 30 minutes after ending hyperoxia
Retinal vessel diameters during hyperglycemia
Time Frame: Before glucose ingestion, every 30 minutes for 3 hours following oral glucose load
Measurement of retinal vessel diameters before, during and after hyperglycemic stimulation.
Before glucose ingestion, every 30 minutes for 3 hours following oral glucose load
Retinal perfusion during hyperglycemia
Time Frame: Before glucose ingestion, every 30 minutes for 3 hours following oral glucose load
Measurement of retinal perfusion velocities before, during and after hyperglycemic stimulation.
Before glucose ingestion, every 30 minutes for 3 hours following oral glucose load
Retinal oximetry during hyperglycemia
Time Frame: Before glucose ingestion, every 30 minutes for 3 hours following oral glucose load
Measurement of retinal oximetry status before, during and after hyperglycemic stimulation.
Before glucose ingestion, every 30 minutes for 3 hours following oral glucose load

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glostrup University Hospital, Copenhagen

Investigators

  • Principal Investigator: Oliver Klefter, MD, Glostrup UH
  • Study Director: Michael Larsen, Professor, DMSci, Glostrup UH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

October 31, 2012

First Submitted That Met QC Criteria

November 2, 2012

First Posted (Estimate)

November 6, 2012

Study Record Updates

Last Update Posted (Estimate)

March 11, 2015

Last Update Submitted That Met QC Criteria

March 10, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • Klefter2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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