- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05209204
Anterior Chamber Angle Examination in Angle Closure Suspect Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Glaucoma is a form of progressive optic neuropathy and is one of the leading causes of preventable blindness worldwide. The average life span is increasing leading to more individuals developing glaucoma as well as having the disease longer, which makes early detection and management very important.[1] Glaucoma is characterized by loss of retinal ganglion cells (RGCs) recognized as optic nerve head (ONH) changes, corresponding visual field (VF) defects and retinal nerve fiber layer (RNFL) loss. At least 40% of RGCs are lost before the VFs show a defect, hence the emphasis on early diagnosis in the stage of glaucoma suspect.[2] There are two types of glaucoma suspect: Primary Open angle and primary angle closure suspect.(3) Primary angle-closure (PAC) suspects can be detected by the following: the trabecular meshwork can only be seen in 180º or less of anterior chamber angle (AC) by gonioscopy, the intraocular pressure(IOP) remains within normal limits and no structural damage to the optic nerve is present.[4] Time domain Optical coherence tomography (TD-OCT) was initially designed to image the posterior segment and retina, but its capability to generate cross-sectional images of internal biological structures without contacting the ocular surface was quickly adapted to visualize the anterior segment and cornea.[5].
Spectral domain anterior segment OCT (SD-OCT) technology allow visualizing the anterior chamber angle of the eye with high speed and high resolution. Spectral-domain OCT(SD OCT) instruments working at 840 nm can reliably identify fine angle structures such as Schwalbe's line.(6) Scheimpflug imaging also offers non-contact imaging of the anterior segment. Although Scheimpflug photography cannot fully visualize the entire angle, the software available on the Pentacam system (Oculus Optikgeräte, Wetzlar, Germany) provides extrapolated measurements of the anterior chamber volume (ACV), which have shown promise in screening for narrow angles.(7)
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Minya, Egypt
- Minia University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Hyperopes. 2-Shallow AC. 3-With gonioscopy carried out under dim-light conditions without indentation ,with the eye in primary position there is inability to visualize ≤ 180° of the posterior trabecular meshwork (TM) in the absence of peripheral anterior 4-IOP ≤ 21 as measured by tonometry. 5-Normal visual field on static automated perimetry (SAP) testing. 5-Normal optic nerve head (ONH) appearance on fundus biomicroscopy. 6-Family history of primary angle closure disease.
Exclusion Criteria:
1-Eyes with significant corneal opacity that can impare signal strings of any of the used imaging modalities.
2-Eyes wih history of intraocular surgery (e.g. cataract surgery ,retinal detachment surgery).
3-Eyes with history of laser procedures (e.g.laser peripheral iridotomy). 4-Eyes with anterior segment pathology as iridocyclitis or angle disgenesis 5. Eyes with history of trauma. 6- Eyes with findings suggestive of 2dry cause of glaucoma (e.g. iris or angle neovascularization, any iris or corneal abnormalities, dilated episcleral vessels ).
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
40 pateint glucoma suspect
ASOCT
|
Anterior segment imaging using RTVue XR 100 Avanti OCT platform (Optovue Inc.,Fairmont, CA).
Anterior segment imaging using Oculus Pentacam HR (Oculus Optikgeräte, Wetzlar, Germany).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anterior segment parameters as measured by AS-OCT:
Time Frame: 3 months
|
Anterior chamber depth (ACD)..
|
3 months
|
|
Anterior segment parameters as measured by Oculus Pentacam:
Time Frame: 3 months
|
Anterior chamber angle (ACA).
|
3 months
|
|
Anterior segment parameters by ASOCT
Time Frame: 3 months
|
Angle opening distance at 750 µm (AOD750).
|
3 months
|
|
Anterior segment parameters by OCT
Time Frame: 3 months
|
Anterior chamber angle (ACA).
|
3 months
|
|
Pentacam parameters
Time Frame: 3 months
|
Anterior chamber volume (ACV).
|
3 months
|
|
Pentacam parameters by Oculus Pentacam:
Time Frame: 3 months
|
Anterior chamber depth (ACD).
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mohamed Salah, Minia University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AC angle angle closure suspect
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Glaucoma
-
Hospices Civils de LyonRecruitingOpen-angle Glaucoma | Glaucoma Eye | Pigmentary Glaucoma | Closed-Angle Glaucoma | Pseudo Exfoliative SyndromeFrance
-
Imperial College Healthcare NHS TrustIRIDEX CorporationNot yet recruitingGlaucoma | Glaucoma, Open-Angle | Glaucoma, Angle-Closure | Glaucoma, Neovascular | Glaucoma Eye | Glaucoma Secondary | Glaucoma Traumatic | Glaucoma Uveitic
-
Wills EyeIOP OphthalmicsTerminatedPrimary Open Angle Glaucoma | Neovascular Glaucoma | Uveitic Glaucoma | Pseudoexfoliation Glaucoma | Primary Angle Closure Glaucoma | Pigmentary Glaucoma | Traumatic GlaucomaUnited States
-
University of MiamiAbbVieRecruitingOcular Hypertension | Glaucoma | Open-Angle Glaucoma | Glaucoma SuspectUnited States
-
Ngoc Nguyen Inc.Alcon ResearchNot yet recruitingGlaucoma | Glaucoma, Open Angle | Open Angle Glaucoma (OAG) | Normal Tension Glaucoma (NTG)United States
-
Isfahan University of Medical SciencesActive, not recruitingAngle Closure Glaucoma | Glaucoma EyeIran
-
Centre hospitalier de l'Université de Montréal...CompletedGlaucoma | Glaucoma, Open-Angle | Glaucoma, Neovascular | Glaucoma Eye | Glaucoma and Ocular Hypertension | Glaucoma, Uncompensated | Glaucoma SecondaryCanada
-
Pro Top & Mediking Company LimitedCompletedOpen Angle Glaucoma | Neovascular Glaucoma | Angle Closure Glaucoma | Uveitis Glaucoma | Young Age Glaucoma | High Risk PatientEstonia
-
Henry Ford Health SystemNot yet recruitingPrimary Open Angle Glaucoma (POAG) | Secondary Open Angle Glaucoma | Open Angle Glaucoma (OAG)United States
-
Sanoculis LtdCompletedPrimary Open Angle Glaucoma | Pigmentary Glaucoma | Pseudoexfoliative GlaucomaIsrael
Clinical Trials on ASOCT
-
Sohag UniversityActive, not recruiting