Exploring blood flow and nerve health in glaucoma patients and healthy individuals
Investigation of Neurovascular Coupling in Glaucoma Patients and Healthy Subjects
This study is trying to see how blood flow affects nerve health in people with glaucoma compared to healthy individuals to find ways to protect vision.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 1 site (Vienna) |
| Trial ID | NCT03870230 on ClinicalTrials.gov |
What this trial studies
This investigation focuses on understanding neurovascular coupling in patients with glaucoma and healthy subjects. It aims to explore how blood flow in the retina is regulated and its relationship with retinal ganglion cell health, which is crucial for vision. The study employs advanced imaging techniques such as Fourier Domain Doppler Optical Coherence Tomography and Pattern Electroretinography to assess these parameters. By examining both glaucoma patients and healthy controls, the study seeks to identify potential neuroprotective strategies that could benefit those with glaucoma.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with primary open-angle glaucoma, normal tension glaucoma, or ocular hypertension.
Not a fit: Patients with other forms of glaucoma or those without any signs of glaucoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new neuroprotective treatments for glaucoma that do not rely solely on lowering intraocular pressure.
How similar studies have performed: While there has been significant interest in neuroprotection for glaucoma, this specific approach focusing on neurovascular coupling is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria Patients with primary open angle glaucoma * Diagnosis of manifest primary open angle glaucoma defined as pathological optic disc appearance * Glaucoma hemifield test outside normal limits * Untreated IOP ≥ 21 mmHg on at least three measurements in the medical history * Mean deviation in the visual field test is less than or equal 10dB (for one group) OR more than 10dB (for the other group) Patients with normal tension glaucoma * Diagnosis of manifest normal tension glaucoma defined as pathological optic disc appearance * Glaucoma hemifield test outside normal limits * No evidence of untreated IOP \> 20 mmHg in the medical history * Mean deviation in the visual field is less than or equal 10dB (for one group) OR more than 10dB (for the other group) Patients with ocular hypertension * Normal ophthalmic findings except presence of ocular hypertension defined as untreated IOP ≥ 21 mmHg on at least three measurements in the medical history * No signs of glaucomatous damage in the optic disc * or the glaucoma hemifield test Healthy control subjects * Normal ophthalmic findings * IOP \< 20 mmHg on least three measurements * No evidence of increased IOP in the medical history * No signs of glaucomatous damage in the optic disc * or the glaucoma hemifield test Exclusion criteria * History of a severe medical condition as judged by the clinical investigator * Abuse of alcoholic beverages * Smoker * Participation in a clinical trial in the 3 weeks preceding the study * Exfoliation glaucoma, pigmentary glaucoma, history of acute angle closure * Intraocular surgery within the last 6 months * Ocular inflammation or infection within the last 3 months * History of epilepsia * Diabetes mellitus * Untreated hypertension with systolic blood pressure \> 160 mmHg, diastolic blood pressure \> 95 mmHg * Pregnancy * Planned pregnancy or lactating
Where this trial is running
Vienna
- Department of Clinical Pharmacology, Medical University of Vienna — Vienna, Austria (Recruiting)
Study contacts
- Principal investigator: Gerhard Garhöfer, MD — Department of Clinical Pharmacology, Medical University of Vienna
- Study coordinator: Gerhard Garhöfer, MD
- Email: gerhard.garhoefer@meduniwien.ac.at
- Phone: 004314040029810
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.