Optical Angiography in Glaucoma

Glaucoma Clinical Trial

Official title:

Optical Angiography in Glaucoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02548676
• Other study ID #: OPHT - 110414
• Status: Completed
• Start date: September 11, 2015
• Est. completion date: November 25, 2016

Study information

• Verified date: April 2022
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Glaucoma is one of the leading causes for blindness in industrialized countries. It is characterized by a progressive loss of retinal ganglion cells, morphological changes in the optic nerve head and a characteristic loss of visual field. It has been speculated for a long time that vascular factors may also contribute to the pathogenesis of the disease. This concept has been supported by several epidemiological studies showing that small retinal vessel calibre are associated with the disease. In the recent years tremendous enhancements in the field of optical coherence tomography has been achieved. These developments made it possible to visualize the retinal vasculature in a full depth manner without the application of an intravenous marker. The proposed study tests the hypothesis that patients with glaucoma show altered vascular morphology compared to healthy subjects. This is of importance because it may clarify the degree of vascular involvement in glaucoma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: November 25, 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of manifest open angle glaucoma as defined as pathological optic disc appearance, glaucoma hemifield test outside normal limits and/or untreated IOP = 21 mmHg on at least three measurements in the medical history. Mean deviation in the visual field test < 10dB

Exclusion Criteria:

• Normal ophthalmic findings, IOP = 20mmHg

• No history of elevated IOP

• No signs of glaucomatous disc damage

Related Conditions & MeSH terms

• Glaucoma

Intervention

Device:
• Optical angiography based on OCT
This measurement will be obtained after the dilation of the pupil. Optical coherence tomography (OCT) is a non-invasive optical imaging modality enabling cross-sectional tomographic in vivo visualization of internal microstructure in biological systems. In ophthalmology OCT has become a standard device in visualizing the retina and is also considered a standard tool in the diagnosis of retinal disease. In optical angiography blood vessels contrasting against static tissue are visualized in a full depth resolved and label-free manner.

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retinal vessel diameter as extracted from the angiograms		during the four weeks after the first screening day
Secondary	Systemic hemodynamics (Blood pressure)		during the four weeks after the first screening day
Secondary	Intraocular pressure		during the four weeks after the first screening day
Secondary	pulse		during the four weeks after the first screening day