Menu
Recruiting NCT07536516

Measurement of Ocular Blood Flow and Retinal Oxygen Extraction in Diabetic Patients

No phase Interventional Diabetes Mellitus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: • Laser Speckle Flowgraphy (LSFG), • Optical Coherence Tomography (OCT), • Optical Coherence Tomography Angiography (OCT-A).
Who it may be relevant to
Registry conditions: Diabetes Mellitus. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The prevalence of diabetes is increasing, with type 2 diabetes mellitus comprising over 90% of cases. Diabetes mellitus complications, including diabetic retinopathy (DR), impose significant health burdens. GLP-1 receptor agonists (GLP-1RAs) and dual GIP/GLP-1 receptor agonists show promise in improving cardiovascular and kidney outcomes, but their effects on retinal microvasculature and neuroprotection remain unclear. This study investigates the impact of GLP-1RAs (semaglutide, liraglutide) and GIP/GLP-1-dual agonists (tirzepatide) on ocular blood flow and retinal function in DM patients.

Interventions

  • Device • Laser Speckle Flowgraphy (LSFG)
    Laser Speckle Flowgraphy (LSFG)
  • Device • Optical Coherence Tomography (OCT)
    • Optical Coherence Tomography (OCT)
  • Device • Optical Coherence Tomography Angiography (OCT-A)
    • Optical Coherence Tomography Angiography (OCT-A)

Primary outcome measures

  • Ocular blood flow (LSFG) [Time frame: From enrollment to last study day (=5-11 weeks)]
Secondary outcome measures (12)
  • Retinal vessel diameter [Time frame: From enrollment to last study day (=5-11 weeks)]
  • Retinal oxygen saturation [Time frame: From enrollment to last study day (=5-11 weeks)]
  • Retinal oxygen extraction [Time frame: From enrollment to last study day (=5-11 weeks)]
  • Oxygen and carbon dioxide partial pressure in arterialized blood [Time frame: From enrollment to last study day (=5-11 weeks)]
  • Central retinal thickness [Time frame: From enrollment to last study day (=5-11 weeks)]
  • Retinal nerve fiber layer thickness [Time frame: From enrollment to last study day (=5-11 weeks)]
  • Retinal and choroidal microvasculature [Time frame: From enrollment to last study day (=5-11 weeks)]
  • Capillary blood glucose level [Time frame: From enrollment to last study day (=5-11 weeks)]
  • Autonomic and sensomotoric neuropathy measurements [Time frame: From enrollment to last study day (=5-11 weeks)]
  • Ocular perfusion pressure [Time frame: From enrollment to last study day (=5-11 weeks)]
  • Intraocular pressure [Time frame: From enrollment to last study day (=5-11 weeks)]
  • Systemic hemodynamics - Blood pressure [Time frame: From enrollment to last study day (=5-11 weeks)]

Eligibility criteria

Inclusion criteria

  • Men and women aged ≥ 18 years
  • Signed informed consent
  • Previously diagnosed diabetes mellitus
  • Normal ophthalmic findings except diabetic retinopathy, unless the investigator considers an abnormality to be clinically irrelevant
  • Planned initiation of therapy with GLP-1 receptor agonist (Semaglutide, Ozempic®; Liraglutide, Victoza®) or GIP/GLP-1 receptor agonist (Tirzepatide, Mounjaro®) by a diabetes specialist

Exclusion criteria

  • Participation in a clinical trial in the 3 weeks preceding the screening visit
  • Symptoms of a clinically relevant illness in the 3 weeks before the first study day
  • Presence or history of a severe medical condition, except diabetes, as judged by the clinical investigator
  • Abuse of alcoholic beverages
  • Blood donation during the previous three weeks
  • Presence of any abnormalities preventing reliable measurements in the study eye as judged by the investigator
  • Previous laser photocoagulation treatment in the study eye
  • Best corrected visual acuity < 0.4 Snellen
  • Women of childbearing potential (neither menopausal, nor hysterectomized, nor sterilized) not using effective contraception
  • Pregnancy, planned pregnancy or lactation

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Austria · 1 center
  • Medical University Vienna — Vienna

Identifiers

NCT: NCT07536516 · OPHT-25022025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗