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

Not Applicable

• Conditions: Glaucoma
• Interventions: Drug: Pilocarpine

• Registration Number: NCT02865473
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-20
• Study First Submitted: 2016-08-09
• Study First Submitted QC: 2016-08-09
• Study First Posted: 2016-08-12
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-06
• Last Update Posted: 2022-04-07
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
healthy volunteers	Pilocarpine	instillation of antiglaucoma treatment in the study eye

Primary Outcome Measures

Name	Time	Method
3-dimensional imaging of the anterior eye segment	1 day

Trial Locations

Locations (1)

Department of Clinical Pharmacology, Medical University of Vienna; 🇦🇹 Vienna, Austria