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

Sponsor
Medical University of Vienna (Other)
Overall Status
Recruiting
CT.gov ID
NCT02865473
Collaborator
(none)
90
1
6
91.4
1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated 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
Actual Study Start Date :
Apr 20, 2016
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 3-dimensional imaging of the anterior eye segment [1 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Clinical Pharmacology, Medical University of Vienna Vienna Austria 1090

Sponsors and Collaborators

  • Medical University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gerhard Garhofer, Assoc. Prof. PD Dr., Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT02865473
Other Study ID Numbers:
  • OPHT-010915
First Posted:
Aug 12, 2016
Last Update Posted:
Apr 7, 2022
Last Verified:
Apr 1, 2022
Keywords provided by Gerhard Garhofer, Assoc. Prof. PD Dr., Medical University of Vienna
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 7, 2022