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

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ClinicalTrials.gov Identifier: NCT02865473
Recruitment Status : Recruiting
First Posted : August 12, 2016
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna

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.


Condition or disease Intervention/treatment Phase
Glaucoma Drug: Pilocarpine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Anterior Segment Imaging With Ultrahigh-resolution OCT in Patients With Glaucoma and Pseudoexfoliation Syndrome - a Pilot Study
Study Start Date : April 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 3-dimensional imaging of the anterior eye segment [ Time Frame: 1 day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02865473


Contacts
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Contact: Gerhard Garhöfer, Assoc. Prof. PD Dr. 0043140400 ext 29810 gerhard.garhoefer@meduniwien.ac.at

Locations
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Austria
Department of Clinical Pharmacology, Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Gerhard Garhöfer, Assoc. Prof. PD Dr.    0043140400 ext 29810    gerhard.garhoefer@meduniwien.ac.at   
Sub-Investigator: Sabina Sapeta, MD         
Sub-Investigator: René Werkmeister, PhD         
Sub-Investigator: Doreen Schmidl, MD         
Sub-Investigator: Ahmed Bata, MD         
Sub-Investigator: Piotr Wozniak, MD         
Sub-Investigator: Klemens Fondi, MD         
Sub-Investigator: Leopold Schmetterer, PhD         
Sponsors and Collaborators
Medical University of Vienna

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Responsible Party: Gerhard Garhofer, Assoc. Prof. PD Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02865473     History of Changes
Other Study ID Numbers: OPHT-010915
First Posted: August 12, 2016    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Keywords provided by Gerhard Garhofer, Medical University of Vienna:
Schlemm's canal lumen area
PEX
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases
Pilocarpine
Miotics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action