Optical Angiography in Glaucoma

NCT02548676 | Completed

• 1 other identifier: OPHT - 110414
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

• Retinal vessel diameter as extracted from the angiograms

  during the four weeks after the first screening day

Secondary Outcomes (3)

• 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

Study Arms (2)

Glaucoma Patients

Patients with primary open angle glaucoma

Device: Optical angiography based on OCT

Healthy controls

age- and sex matched controls

Device: Optical angiography based on OCT

Interventions

Optical angiography based on OCT DEVICE

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.

Glaucoma Patients; Healthy controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Normal ophthalmic findings, IOP ≤ 20mmHg
• No history of elevated IOP
• No signs of glaucomatous disc damage

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, Austria

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. PD Dr.

Study Record Dates

• First Submitted: September 4, 2015
• First Posted: September 14, 2015
• Study Start: September 11, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 25, 2016
• Last Updated: April 7, 2022

Record last verified: 2022-04

Locations

AU (1)