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

NCT06278597 | Completed

• 1 other identifier: GLC02-22
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (2)

• Agreement between the automatic Narrow Anterior Chamber Angle Estimator grading of peripheral anterior chamber width with clinical grading as performed by Van Herick (VH) test at slit lamp

  The angle is graded by the NACA estimator as the ratio between the peripheral anterior chamber depth and limbal-corneal thickness, as observed in the slit lamp by the microscope section. A high-resolution camera will synchronously acquire the images to generate the irido-corneal angle grade that will be classified in four grades following the VH classification. The standard VH grading scale will be: * 1 = space between iris and corneal endothelium of \<¼ corneal thickness (angle closure likely), * 2 = space between iris and corneal endothelium of ¼ corneal thickness (angle closure possible), * 3 = space between iris and corneal endothelium of ½ corneal thickness (angle closure unlikely), * 4 = space between iris and corneal endothelium ≥ 1 (corneal thickness angle closure very unlikely).

  12 months

• Agreement between the automatic Narrow Anterior Chamber Angle Estimator grading of peripheral anterior chamber width with clinical grading as performed by gonioscopy.

  The angle will be graded for each quadrant at gonioscopy using the modified Shaffer grading system, by which each grade corresponds to the visibility of the different angle structures.

  12 months

Secondary Outcomes (2)

• Reproducibility (intra-session) and repeatability (inter-session) of the peripheral anterior chamber width (PACW) evaluation by the Narrow Anterior Chamber Angle Estimator

  12 months

• Sensitivity and specificity of NACA Estimator grading of PACW in detecting primary angle closure suspects as classified by clinical gonioscopy.

  12 months

Interventions

NACA Estimator DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willingness to participate and ability to understand and sign an informed consent.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione G.B. Bietti, IRCCS: lead

Study Sites (1)

IRCCS Fondazione GB Bietti

Roma, Italy, 00184, Italy

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 26, 2024
• Study Start: September 5, 2023
• Primary Completion: January 20, 2024
• Study Completion: December 31, 2024
• Last Updated: March 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)