Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06278597
Status:
RECRUITING
Last Update Posted:
2024-02-26
First Post:
2024-02-15
Brief Title:
Automatic Evaluation of the Anterior Chamber Angle Width by a New Non-contact Optical Device
Sponsor:
Fondazione GB Bietti IRCCS
Organization:
Fondazione GB Bietti IRCCS
Study Overview
Official Title:
Automatic Evaluation of the Anterior Chamber Angle Width by a New Non-contact Optical Device
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None