Glaucoma,Primary Open-Angle ,Primary Angle ClosureNCT06000176
Comparison of Optical Coherence Tomography Angiography Microvascular Changes in Primary Open Angle and Primary Angle Closure Glaucoma
An observational study of Glaucoma,Primary Open-Angle ,Primary Angle Closure, run by Omar Said at 1 site in Egypt.
Trial summary
This work aims to study the peripapillary and macular microvascular changes in primary open angle and primary angle closure glaucoma using Optical Coherence Tomography Angiography (OCTA). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma,Primary Open-Angle ,Primary Angle Closure
- What is being tested?
- Optical coherence tomography angiography
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Apr 2022to 20 Jul 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with primary open angle ,primary angle closure glaucoma and control patients
Who may be able to join
- Age ≥ 18 years old.
- Fulfilling Diagnostic criteria of PACG patients :occluded angle by gonioscopy in which > 180˚ of trabecular meshwork cannot be seen , IOP>21, Optic disc and RNFL damage due to glaucoma
- Diagnosed POAG patient: open anterior chamber angle ,IOP>21 ,Optic disc and RNFL damage due to glaucoma
- Healthy patient: normal anterior chamber, open angle and normal fundus.
Who cannot join
- History of other causes of optic neuropathy.
- History of systemic diseases. (HTN, DM, Cardiac).
- Previous ocular surgeries or Laser iridotomy.
- Poor quality of OCTA image less than 4/10.
- Refractive errors > 6 diopters sphere, >3 diopter cylinder
- Poor cooperation or fixation with the OCTA examination.
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- Secondary causes of glaucoma
- Media opacity that interfere with quality of image (dense cataract,corneal opacity,…)
- Previous acute attack of ACG
Trial locations and contacts
1 site in 1 country.
About this study
This work aims to study the peripapillary and macular microvascular changes in primary open angle and primary angle closure glaucoma using Optical Coherence Tomography Angiography (OCTA).
Read the detailed description
After approval of the local institutional ethics committee and local institutional review board, all patients presenting to the outpatient clinic of the department of Ophthalmology in the universities has been subjected to routine ophthalmological examination including: best corrected visual acuity (BCVA), Slit-lamp evaluation of anterior segment, IOP by Goldmann applanation tonometer, Gonioscopy using gonio contact lens, Fundus examination by indirect opthalmoscope with history taking focusing on positive family history of glaucoma after a detailed informed consent was signed by eligible patients and investigated by OCTA of the Peripapillary and Macular vascular density on presentation using AngiVue (Optovue, Inc., Fremont, CA, USA).
Data analysis performed using the Statistical Package of Social Science (SPSS) software version 22 in windows 7 (SPSS Inc., Chicago, IL, USA) Simple descriptive statistical analysis in the form of numbers and percentages of qualitative data, and arithmetic means as central tendency measurement, standard deviations as a measure of dispersion of quantitative parametric data.
For quantitative parametric data: Independent samples test was used to compare quantitative measures between two independent groups, One-way analysis of variance ANOVA test used to compare quantitative measures between more than two independent groups of quantitative data with the benferroni Post-HOC to test the significance between each two groups, Paired t-test used to compare two dependent quantitative data.
For qualitative data Chi square test used to compare between two or more than two qualitative groups.
Bivariate Pearson correlation test to test the association between variables The probability value (P-value) < 0.05 was considered as statistical significant
- Being tested
- Optical coherence tomography angiography
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical coherence tomography angiographyDevice
diagnostic test OCTA macula and ONH
| Study group | Role | What they receive |
|---|---|---|
| interventional details : diagnostic test OCTA macula and ONH | interventional details : diagnostic test OCTA macula and ONH in the 3 groups Receives: Device: Optical coherence tomography angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
OCTA macula and ONH
macular 6*6,3*3 and peripapillary vessel density
Measured: We will recruit patient that include the inclusion criteria from april2022 to july 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start5 Apr 2022
- Primary completion20 Jul 2023
- Study completion20 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma,Primary Open-Angle ,Primary Angle ClosureStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Omar Said
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Omar Said, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06000176
- Sponsor's protocol ID
- M557
- Status last verified
- Aug 2023
- First submitted
- 12 Aug 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Optical Coherence Tomography Angiography Microvascular Changes in Primary Open Angle and Primary Angle Closure Glaucoma
- ClinicalTrials.gov ID
- NCT06000176
- Acronym / sponsor ID
- M557
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Omar SaidUniversity, hospital or other
- Study start
- 5 Apr 2022 (actual)
- Primary completion
- 20 Jul 2023 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 21 Aug 2023 (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.
This work aims to study the peripapillary and macular microvascular changes in primary open angle and primary angle closure glaucoma using Optical Coherence Tomography Angiography (OCTA).
Detailed description
After approval of the local institutional ethics committee and local institutional review board, all patients presenting to the outpatient clinic of the department of Ophthalmology in the universities has been subjected to routine ophthalmological examination including: best corrected visual acuity (BCVA), Slit-lamp evaluation of anterior segment, IOP by Goldmann applanation tonometer, Gonioscopy using gonio contact lens, Fundus examination by indirect opthalmoscope with history taking focusing on positive family history of glaucoma after a detailed informed consent was signed by eligible patients and investigated by OCTA of the Peripapillary and Macular vascular density on presentation using AngiVue (Optovue, Inc., Fremont, CA, USA).
Data analysis performed using the Statistical Package of Social Science (SPSS) software version 22 in windows 7 (SPSS Inc., Chicago, IL, USA) Simple descriptive statistical analysis in the form of numbers and percentages of qualitative data, and arithmetic means as central tendency measurement, standard deviations as a measure of dispersion of quantitative parametric data.
For quantitative parametric data: Independent samples test was used to compare quantitative measures between two independent groups, One-way analysis of variance ANOVA test used to compare quantitative measures between more than two independent groups of quantitative data with the benferroni Post-HOC to test the significance between each two groups, Paired t-test used to compare two dependent quantitative data.
For qualitative data Chi square test used to compare between two or more than two qualitative groups.
Bivariate Pearson correlation test to test the association between variables The probability value (P-value) < 0.05 was considered as statistical significant
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| interventional details : diagnostic test OCTA macula and ONH | – | Device: Optical coherence tomography angiographyinterventional details : diagnostic test OCTA macula and ONH in the 3 groups |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with primary open angle ,primary angle closure glaucoma and control patients
Key inclusion criteria (4 listed)
- Age ≥ 18 years old.
- Fulfilling Diagnostic criteria of PACG patients :occluded angle by gonioscopy in which > 180˚ of trabecular meshwork cannot be seen , IOP>21, Optic disc and RNFL damage due to glaucoma
- Diagnosed POAG patient: open anterior chamber angle ,IOP>21 ,Optic disc and RNFL damage due to glaucoma
- Healthy patient: normal anterior chamber, open angle and normal fundus.
Key exclusion criteria (9 listed)
- History of other causes of optic neuropathy.
- History of systemic diseases. (HTN, DM, Cardiac).
- Previous ocular surgeries or Laser iridotomy.
- Poor quality of OCTA image less than 4/10.
- Refractive errors > 6 diopters sphere, >3 diopter cylinder
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 |
|---|---|---|
| Optical coherence tomography angiographydiagnostic test OCTA macula and ONH | Device | interventional details : diagnostic test OCTA macula and ONH |
Primary outcome
OCTA macula and ONH
Time frame: We will recruit patient that include the inclusion criteria from april2022 to july 2023
macular 6*6,3*3 and peripapillary vessel density
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 21 Aug 2023.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Glaucoma,Primary Open-Angle ,Primary Angle Closure, run by Omar Said 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 4 inclusion and 9 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 21 Aug 2023. 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?
OCTA macula and ONH (time frame: We will recruit patient that include the inclusion criteria from april2022 to july 2023). 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 21 Aug 2023.