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Optical Angiography in Glaucoma

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ClinicalTrials.gov Identifier: NCT02548676
Recruitment Status : Active, not recruiting
First Posted : September 14, 2015
Last Update Posted : December 6, 2017
Sponsor:
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna

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
Glaucoma Device: Optical angiography based on OCT

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Optical Angiography in Glaucoma
Study Start Date : April 2015
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

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.




Primary Outcome Measures :
  1. Retinal vessel diameter as extracted from the angiograms [ Time Frame: during the four weeks after the first screening day ]

Secondary Outcome Measures :
  1. Systemic hemodynamics (Blood pressure) [ Time Frame: during the four weeks after the first screening day ]
  2. Intraocular pressure [ Time Frame: during the four weeks after the first screening day ]
  3. pulse [ Time Frame: during the four weeks after the first screening day ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
30 open angle glaucoma patients 30 healthy age- and sex matched controls
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02548676


Locations
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Austria
Medical University of Vienna
Vienna, Austria
Sponsors and Collaborators
Medical University of Vienna

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Responsible Party: Gerhard Garhofer, Assoc. Prof. PD Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02548676     History of Changes
Other Study ID Numbers: OPHT - 110414
First Posted: September 14, 2015    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases