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

Primary Purpose

Glaucoma

Status

Recruiting

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

Pilocarpine

About this trial

This is an interventional basic science trial for Glaucoma focused on measuring Schlemm's canal lumen area, PEX

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Department of Clinical Pharmacology, Medical University of ViennaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

No Intervention

Experimental

Arm Label

primary open angle glaucoma patients

patients with primary angle closure

patients with neovascular glaucoma

PEX glaucoma patients

glaucoma patients with filtering bleb

healthy volunteers

Arm Description

instillation of antiglaucoma treatment in the study eye

Outcomes

Primary Outcome Measures

3-dimensional imaging of the anterior eye segment

Secondary Outcome Measures

Full Information

NCT ID

NCT02865473

First Posted

August 9, 2016

Last Updated

April 6, 2022

Sponsor

Medical University of Vienna

1. Study Identification

Unique Protocol Identification Number

NCT02865473

Brief Title

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

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 20, 2016 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of Vienna

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma

Keywords

Schlemm's canal lumen area, PEX

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

primary open angle glaucoma patients

Arm Type

No Intervention

Arm Title

patients with primary angle closure

Arm Type

No Intervention

Arm Title

patients with neovascular glaucoma

Arm Type

No Intervention

Arm Title

PEX glaucoma patients

Arm Type

No Intervention

Arm Title

glaucoma patients with filtering bleb

Arm Type

No Intervention

Arm Title

healthy volunteers

Arm Type

Experimental

Arm Description

instillation of antiglaucoma treatment in the study eye

Intervention Type

Drug

Intervention Name(s)

Pilocarpine

Intervention Description

topical instillation into the study eye

Primary Outcome Measure Information:

Title

3-dimensional imaging of the anterior eye segment

Time Frame

1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gerhard Garhöfer, Assoc. Prof. PD Dr.

Phone

0043140400

Ext

29810

gerhard.garhoefer@meduniwien.ac.at

Facility Information:

Facility Name

Department of Clinical Pharmacology, Medical University of Vienna

City

Vienna

ZIP/Postal Code

1090

Country

Austria

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gerhard Garhöfer, Assoc. Prof. PD Dr.

Phone

0043140400

Ext

29810

gerhard.garhoefer@meduniwien.ac.at

First Name & Middle Initial & Last Name & Degree

Sabina Sapeta, MD

First Name & Middle Initial & Last Name & Degree

René Werkmeister, PhD

First Name & Middle Initial & Last Name & Degree

Doreen Schmidl, MD

First Name & Middle Initial & Last Name & Degree

Ahmed Bata, MD

First Name & Middle Initial & Last Name & Degree

Piotr Wozniak, MD

First Name & Middle Initial & Last Name & Degree

Klemens Fondi, MD

First Name & Middle Initial & Last Name & Degree

Leopold Schmetterer, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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