Optical Angiography in Glaucoma

Sponsor
Medical University of Vienna (Other)
Overall Status
Completed
CT.gov ID
NCT02548676
Collaborator
(none)
61
1
14.5
4.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Optical angiography based on OCT

Study Design

Study Type:
Observational
Actual Enrollment :
61 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Optical Angiography in Glaucoma
Actual Study Start Date :
Sep 11, 2015
Actual Primary Completion Date :
Nov 1, 2016
Actual Study Completion Date :
Nov 25, 2016

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Retinal vessel diameter as extracted from the angiograms [during the four weeks after the first screening day]

Secondary Outcome Measures

  1. Systemic hemodynamics (Blood pressure) [during the four weeks after the first screening day]

  2. Intraocular pressure [during the four weeks after the first screening day]

  3. pulse [during the four weeks after the first screening day]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical University of Vienna Vienna Austria

Sponsors and Collaborators

  • Medical University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gerhard Garhofer, Assoc. Prof. PD Dr., Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT02548676
Other Study ID Numbers:
  • OPHT - 110414
First Posted:
Sep 14, 2015
Last Update Posted:
Apr 7, 2022
Last Verified:
Apr 1, 2022
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 7, 2022