Clinical trial NCT02865473: Anterior Segment Imaging With Ultrahigh-resolution OCT in Patients With Glaucoma and PEX - a Pilot Study
Official title: Anterior Segment Imaging With Ultrahigh-resolution OCT in Patients With Glaucoma and Pseudoexfoliation Syndrome - a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glaucoma
Keywords: Schlemm's canal lumen area
PEX
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2016-08-12
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the present study is to develop a measurement protocol for optimal imaging of the anterior segment of the eye, including anterior chamber angle, Schlemm's canal, filtering bleb and pseudoexfoliation deposits on the lens based on measurements in patients with glaucoma and PEX. In glaucoma the structures of the anterior chamber are important for classification, therapy, progression and prognosis and imaging of the angle between the iris and the cornea is the key for open angle and closed angle glaucoma differential diagnosis. For this purpose, a customized ultrahigh resolution Spectral Domain OCT will be used to validate whether the protocol can also be more widely applied in these patients. Based on the obtained measurement protocol, further studies investigating anatomy and pathophysiology of the anterior segment of the eye as well as surgical outcome in patients with glaucoma and PEX can be planned.

The aim of the study is to develop a measurement protocol for OCT imaging and characterization of the anterior chamber in glaucoma patients.


Eligibility criteria: Inclusion Criteria:

* Men and women aged over 18 years

For patients with primary open angle glaucoma:

* Diagnosed primary open angle glaucoma
* Visual field defects and optic nerve head appearance characteristic for glaucoma
* Open anterior chamber angle as evidenced by gonioscopy
* No previous glaucoma surgery
* No previous cataract surgery

For patients with primary angle closure:

* Angle closure predisposition as evidenced from goniosocopy
* No previous glaucoma surgery

For patients with neovascular glaucoma:

- Neovascularization in the anterior chamber angle

For patients with pseudoexfolation deposits on the lens:

* PEX glaucoma as evidenced from slit lamp examination
* Visual field defects and optic nerve head appearance characteristic for glaucoma
* Open anterior chamber angle as evidenced by gonioscopy
* No previous glaucoma or cataract surgery

For glaucoma patients with filtering bleb after trabeculectomy:

* Patients with history of trabeculectomy secondary to open angle glaucoma in the previous three months
* No cataract surgery

For healthy volunteers:

* No evidence of ocular disease
* No degenerative changes in the retina in funduscopy after mydriasis
* Ametropia less than 3 dpt.

Exclusion Criteria:

* Presence of any abnormalities preventing reliable measurements as judged by the investigator
* Pregnancy, planned pregnancy or lactating
* Ocular inflammation and ocular disease interfering with the study aims as judged by the investigator

Primary outcomes:
measure: 3-dimensional imaging of the anterior eye segment
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Clinical Pharmacology, Medical University of Vienna
Study officials:
References: