GlaucomaNCT06278597
Automatic Evaluation of the Anterior Chamber Angle Width by a New Non-contact Optical Device
A study testing NACA Estimator in people with Glaucoma, run by Fondazione G.B. Bietti, IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- NACA Estimator
- How many people
- 64 participants
- Where
- 1 siteItaly
- Study dates
- 5 Sep 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- NACA Estimator
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NACA EstimatorDiagnostic test
Grading of peripheral anterior chamber width with the Narrow Anterior Chamber Angle (NACA) Estimator
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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
Measured: 12 months
Sensitivity and specificity of NACA Estimator grading of PACW in detecting primary angle closure suspects as classified by clinical gonioscopy.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start5 Sep 2023
- Primary completion20 Jan 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione G.B. Bietti, IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06278597
- Sponsor's protocol ID
- GLC02-22
- Status last verified
- Feb 2025
- First submitted
- 15 Feb 2024
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automatic Evaluation of the Anterior Chamber Angle Width by a New Non-contact Optical Device
- ClinicalTrials.gov ID
- NCT06278597
- Acronym / sponsor ID
- GLC02-22
- Conditions
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Fondazione G.B. Bietti, IRCCSUniversity, hospital or other
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 20 Jan 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 26 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NACA EstimatorGrading of peripheral anterior chamber width with the Narrow Anterior Chamber Angle (NACA) Estimator | Diagnostic test | – |
Primary outcome
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
Time frame: 12 months
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).
Agreement between the automatic Narrow Anterior Chamber Angle Estimator grading of peripheral anterior chamber width with clinical grading as performed by gonioscopy.
Time frame: 12 months
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.
2 secondary outcomes
Reproducibility (intra-session) and repeatability (inter-session) of the peripheral anterior chamber width (PACW) evaluation by the Narrow Anterior Chamber Angle Estimator
Time frame: 12 months
Sensitivity and specificity of NACA Estimator grading of PACW in detecting primary angle closure suspects as classified by clinical gonioscopy.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NACA Estimator in people with Glaucoma, run by Fondazione G.B. Bietti, IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.