Optical Angiography in Glaucoma

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Device: Optical angiography based on OCT

• Study Type: Observational
• Enrollment (Actual): 61

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria
    • Medical University of Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

30 open angle glaucoma patients 30 healthy age- and sex matched controls

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Glaucoma Patients; Patients with primary open angle glaucoma	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.
Healthy controls; age- and sex matched controls	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Retinal vessel diameter as extracted from the angiograms	during the four weeks after the first screening day

Secondary Outcome Measures

Outcome Measure	Time Frame
Systemic hemodynamics (Blood pressure)	during the four weeks after the first screening day
Intraocular pressure	during the four weeks after the first screening day
pulse	during the four weeks after the first screening day

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2015
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 25, 2016

Study Registration Dates

• First Submitted: September 4, 2015
• First Submitted That Met QC Criteria: September 10, 2015
• First Posted (Estimate): September 14, 2015

Study Record Updates

• Last Update Posted (Actual): April 7, 2022
• Last Update Submitted That Met QC Criteria: April 6, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: OPHT - 110414