Anterior Segment Imaging With Ultrahigh-resolution OCT in Patients With Glaucoma and PEX - a Pilot Study

NCT ID: NCT02865473

Last Updated: 2022-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-20

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Glaucoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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primary open angle glaucoma patients

Group Type NO_INTERVENTION

No interventions assigned to this group

patients with primary angle closure

Group Type NO_INTERVENTION

No interventions assigned to this group

patients with neovascular glaucoma

Group Type NO_INTERVENTION

No interventions assigned to this group

PEX glaucoma patients

Group Type NO_INTERVENTION

No interventions assigned to this group

glaucoma patients with filtering bleb

Group Type NO_INTERVENTION

No interventions assigned to this group

healthy volunteers

instillation of antiglaucoma treatment in the study eye

Group Type EXPERIMENTAL

Pilocarpine

Intervention Type DRUG

topical instillation into the study eye

Interventions

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Pilocarpine

topical instillation into the study eye

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Gerhard Garhofer

Assoc. Prof. PD Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Clinical Pharmacology, Medical University of Vienna

Vienna, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Gerhard Garhöfer, Assoc. Prof. PD Dr.

Role: CONTACT

0043140400 ext. 29810

Facility Contacts

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Gerhard Garhöfer, Assoc. Prof. PD Dr.

Role: primary

0043140400 ext. 29810

Other Identifiers

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OPHT-010915

Identifier Type: -

Identifier Source: org_study_id

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