GlaucomaNCT05209204
Anterior Chamber Angle Examination in Angle Closure Suspect Patients
An observational study of Glaucoma, run by Minia University at 1 site in Egypt.
Trial summary
The aim of this study is to detect PACG suspects using both AS OCT and Scheimpflug imaging. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- ASOCT and Pentacam
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2019to 1 Jan 2020
- Phase
- Observational
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Residents of Minia Governorate diagnosed with SLE with renal affection and without renal affection.
Who may be able to join
- 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.
Who cannot join
- 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 ).
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to detect PACG suspects using both AS OCT and Scheimpflug imaging.
Read the 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)
- Conditions
- Glaucoma
- Being tested
- ASOCT, Pentacam
- Keywords
- Angle closure, ASOCT
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASOCTDiagnostic test
Anterior segment imaging using RTVue XR 100 Avanti OCT platform (Optovue Inc.,Fairmont, CA).
PentacamDiagnostic test
Anterior segment imaging using Oculus Pentacam HR (Oculus Optikgeräte, Wetzlar, Germany).
| Study group | Role | What they receive |
|---|---|---|
| 40 pateint glucoma suspect | ASOCT Receives: Diagnostic Test: ASOCT; Diagnostic Test: Pentacam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior segment parameters as measured by AS-OCT:
Anterior chamber depth (ACD)..
Measured: 3 months
Anterior segment parameters as measured by Oculus Pentacam:
Anterior chamber angle (ACA).
Measured: 3 months
Anterior segment parameters by ASOCT
Angle opening distance at 750 µm (AOD750).
Measured: 3 months
Anterior segment parameters by OCT
Anterior chamber angle (ACA).
Measured: 3 months
Pentacam parameters
Anterior chamber volume (ACV).
Measured: 3 months
Pentacam parameters by Oculus Pentacam:
Anterior chamber depth (ACD).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start1 Apr 2019
- Primary completion1 Dec 2019
- Study completion1 Jan 2020
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.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Salah, Minia University
- Investigators
- Mohamed Salah, Principal investigator, Minia University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05209204
- Sponsor's protocol ID
- AC angle angle closure suspect
- Status last verified
- Jan 2022
- First submitted
- 7 Jan 2022
- Last updated
- 26 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Chamber Angle Examination in Angle Closure Suspect Patients
- ClinicalTrials.gov ID
- NCT05209204
- Acronym / sponsor ID
- AC angle angle closure suspect
- Conditions
- Glaucoma
- Keywords
- Angle closure, ASOCT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 26 Jan 2022 (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 this study is to detect PACG suspects using both AS OCT and Scheimpflug imaging.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 40 pateint glucoma suspect | – | Diagnostic Test: ASOCT, Diagnostic Test: PentacamASOCT |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Residents of Minia Governorate diagnosed with SLE with renal affection and without renal affection.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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 ).
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 |
|---|---|---|
| ASOCTAnterior segment imaging using RTVue XR 100 Avanti OCT platform (Optovue Inc.,Fairmont, CA). | Diagnostic test | 40 pateint glucoma suspect |
| PentacamAnterior segment imaging using Oculus Pentacam HR (Oculus Optikgeräte, Wetzlar, Germany). | Diagnostic test | 40 pateint glucoma suspect |
Primary outcome
Anterior segment parameters as measured by AS-OCT:
Time frame: 3 months
Anterior chamber depth (ACD)..
Anterior segment parameters as measured by Oculus Pentacam:
Time frame: 3 months
Anterior chamber angle (ACA).
Anterior segment parameters by ASOCT
Time frame: 3 months
Angle opening distance at 750 µm (AOD750).
Anterior segment parameters by OCT
Time frame: 3 months
Anterior chamber angle (ACA).
Pentacam parameters
Time frame: 3 months
Anterior chamber volume (ACV).
Pentacam parameters by Oculus Pentacam:
Time frame: 3 months
Anterior chamber depth (ACD).
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 26 Jan 2022.
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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.
Mohamed Salah principal investigator
Minia University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, run by Minia University at 1 site in Egypt.
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 1 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 26 Jan 2022. 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 Egypt. 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?
Anterior segment parameters as measured by AS-OCT: (time frame: 3 months). The study lists 6 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 26 Jan 2022.