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

April 6, 2022 updated by: Gerhard Garhofer, Medical University of Vienna

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Recruiting
        • Department of Clinical Pharmacology, Medical University of Vienna
        • Contact:
        • Sub-Investigator:
          • Sabina Sapeta, MD
        • Sub-Investigator:
          • René Werkmeister, PhD
        • Sub-Investigator:
          • Doreen Schmidl, MD
        • Sub-Investigator:
          • Piotr Wozniak, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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
Experimental: healthy volunteers
instillation of antiglaucoma treatment in the study eye
Drug: Pilocarpine
topical instillation into the study eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
3-dimensional imaging of the anterior eye segment
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2016

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

August 9, 2016

First Submitted That Met QC Criteria

August 9, 2016

First Posted (Estimate)

August 12, 2016

Study Record Updates

Last Update Posted (Actual)

April 7, 2022

Last Update Submitted That Met QC Criteria

April 6, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPHT-010915

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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