Automatic Evaluation of the Anterior Chamber Angle Width by a New Non-contact Optical Device

NCT ID: NCT06278597

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-05
• Study Completion Date: 2024-12-31

Brief Summary

The aim of the study is to evaluate an objective, non-invasive optical device able to quantify, without eye contact, the width of the irido-corneal angle and to better identify cases of narrow angle or angle closure that may be prevented with relatively simple treatments.

Detailed Description

Worldwide, glaucoma has been identified as a leading cause of blindness, second only to cataract. The two most common types of glaucoma are primary open-angle and angle closure glaucoma (PACG), both characterized by progressive and irreversible degeneration of the retinal ganglion cells and axons. In PACG, the optic neuropathy occurs as a consequence of raised intraocular pressure (IOP) resulting from physical obstruction of aqueous outflow or degenerative changes in the trabecular meshwork. Angle closure is the result of an anatomic characteristic that causes closure of the drainage angle by synechial or appositional approximation between the iris and the trabecular meshwork, blocking access to aqueous humor. Although the most common mechanism responsible for angle closure is relative pupillary block, this is not the only one. Angle crowding can be caused by plateaus iris, or by multiple mechanisms such as choroidal thickness and uveal expansion.

A careful analysis of the anterior chamber angle is considered the main management strategy for PACG. The Van Herick grading of limbal anterior chamber depth is considered a screening tool for the estimation of angle width although gonioscopy remains the clinical reference standard for assessing the presence of narrow or closed angle. Ultrasound biomicroscopy, Scheimpflug imaging and anterior segment optical coherence tomography are considered as non-invasive alternatives to gonioscopy. However, these techniques are expensive and also have drawbacks. Therefore, there is a need for an easy and objective method able to evaluate the angle width for screening purposes in clinical practice.

Based on these findings, the purpose of the present study is to evaluate an objective, non-invasive optical device able to quantify, without eye contact, the width of the irido-corneal angle and to better identify cases of narrow angle or angle closure that may be prevented with relatively simple treatments.

Conditions

Glaucoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Interventions

NACA Estimator

Grading of peripheral anterior chamber width with the Narrow Anterior Chamber Angle (NACA) Estimator

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Willingness to participate and ability to understand and sign an informed consent.
• 18 years of age or older.
• Healthy subjects, patients with PACS or angle closure as defined by the EGS Guidelines.
• The right eye will be included in the study for all patients, unless a clinical contraindication to the examination is present.

Exclusion Criteria

• Inability to understand and sign an informed consent.
• Any prior ocular surgery or laser treatment with the potential to alter the natural anatomy of the anterior segment of the eye.
• Corneal or conjunctival abnormalities that preclude an adequate view of the anterior chamber.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fondazione G.B. Bietti, IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IRCCS Fondazione GB Bietti

Roma, Italy, Italy

Countries

Italy

Other Identifiers

GLC02-22

Identifier Type: -

Identifier Source: org_study_id