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

NCT02865473 | Unknown

• 1 other identifier: OPHT-010915
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Keywords

Schlemm's canal lumen area; PEX

Outcome Measures

Primary Outcomes (1)

• 3-dimensional imaging of the anterior eye segment

  1 day

Study Arms (6)

primary open angle glaucoma patients

NO INTERVENTION

patients with primary angle closure

NO INTERVENTION

patients with neovascular glaucoma

NO INTERVENTION

PEX glaucoma patients

NO INTERVENTION

glaucoma patients with filtering bleb

NO INTERVENTION

healthy volunteers

EXPERIMENTAL

instillation of antiglaucoma treatment in the study eye

Drug: Pilocarpine

Interventions

Pilocarpine DRUG

topical instillation into the study eye

healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Glaucoma

Interventions

Pilocarpine

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Central Study Contacts

Gerhard Garhöfer, Assoc. Prof. PD Dr.

CONTACT

0043140400; gerhard.garhoefer@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. PD Dr.

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: August 12, 2016
• Study Start: April 20, 2016
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 7, 2022

Record last verified: 2022-04

Locations

AU (1)