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

Healthy Individuals Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01721811
• Other study ID #: Klefter2
• Status: Recruiting
• Phase: N/A
• First received: October 31, 2012
• Last updated: March 10, 2015
• Start date: October 2012

Study information

• Verified date: March 2015
• Source: Glostrup University Hospital, Copenhagen
• Contact: Oliver Klefter, MD
• Phone: +45 38 63 48 18
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Individuals
• Patients With Diabetes.

Intervention

Other:
• Hyperoxia

• Glucose

Locations

Country	Name	City	State
Denmark	Department of Ophthalmology, Glostrup University Hospital	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retinal vessel diameters during hyperoxia	Measurement of retinal vessel diameters before, during and after hyperoxic stimulation.	Before hyperoxia, after 15 minutes of hyperoxia, 30 minutes after ending hyperoxia	No
Primary	Retinal perfusion velocities during hyperoxia	Measurement of retinal perfusion velocities before, during and after hyperoxic stimulation.	Before hyperoxia, after 15 minutes of hyperoxia, 30 minutes after ending hyperoxia	No
Primary	Retinal oximetry during hyperoxia	Measurement of retinal oximetry status before, during and after hyperoxic stimulation.	Before hyperoxia, after 15 minutes of hyperoxia, 30 minutes after ending hyperoxia	No
Primary	Retinal vessel diameters during hyperglycemia	Measurement of retinal vessel diameters before, during and after hyperglycemic stimulation.	Before glucose ingestion, every 30 minutes for 3 hours following oral glucose load	No
Primary	Retinal perfusion during hyperglycemia	Measurement of retinal perfusion velocities before, during and after hyperglycemic stimulation.	Before glucose ingestion, every 30 minutes for 3 hours following oral glucose load	No
Primary	Retinal oximetry during hyperglycemia	Measurement of retinal oximetry status before, during and after hyperglycemic stimulation.	Before glucose ingestion, every 30 minutes for 3 hours following oral glucose load	No