Glaucoma Clinical Trial
Official title:
Automatic Evaluation of the Anterior Chamber Angle Width by a New Non-contact Optical Device
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.
Status | Recruiting |
Enrollment | 65 |
Est. completion date | January 24, 2025 |
Est. primary completion date | January 20, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS Fondazione GB Bietti | Roma |
Lead Sponsor | Collaborator |
---|---|
Fondazione G.B. Bietti, IRCCS |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Reproducibility (intra-session) and repeatability (inter-session) of the peripheral anterior chamber width (PACW) evaluation by the Narrow Anterior Chamber Angle Estimator | 12 months | ||
Secondary | Sensitivity and specificity of NACA Estimator grading of PACW in detecting primary angle closure suspects as classified by clinical gonioscopy. | 12 months |
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