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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02865473
• Other study ID #: OPHT-010915
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2016
• Est. completion date: December 2023

Study information

• Verified date: April 2022
• Source: Medical University of Vienna
• Contact: Gerhard Garhöfer, Assoc. Prof. PD Dr.
• Phone: 0043140400
• Email: gerhard.garhoefer[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

Drug:
• Pilocarpine
topical instillation into the study eye

Locations

Country	Name	City	State
Austria	Department of Clinical Pharmacology, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-dimensional imaging of the anterior eye segment		1 day