Glaucoma Open-AngleOCTNCT06434155
Social History and Glaucoma Progression
An observational study of Glaucoma Open-Angle, run by Assiut University at 1 site in Egypt.
Trial summary
The objective of this study is to predict of glaucoma progression. By imaging of the retinal nerve fiber layer RNFL, optic nerve head (ONH) and macular measurements using spectral-domain OCT (SD-OCT) instruments Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma Open-Angle
- How many people
- 1,584 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 1 Jul 2022
- How long will I take part?
- 6 Months
- 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 older than 18 years of age with primary open-angle glaucoma (OAG)
Who may be able to join
- IOP measurements more than 21 mmHg
- Open angle on gonioscopy (Grade 3 or 4 on Schaffer grading system for angle width)
- Glaucomatous visual field defects consistent with glaucomatous optic disc changes.
- Eyes with baseline macular and ONH OCT images and ONH photograps
Who cannot join
- Participants with significant retinal disease.
- non-glaucomatous optic neuropathy.
- anomalous discs
- any retinal pathology.
- history of cataract or glaucoma surgery will not be exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Social History and Glaucoma Progression: The Effect of Body Mass Index, Tobacco, and Alcohol Consumption on the Rates of Structural Change in Patients With Open Angle Glaucoma
The objective of this study is to predict of glaucoma progression. By imaging of the retinal nerve fiber layer RNFL, optic nerve head (ONH) and macular measurements using spectral-domain OCT (SD-OCT) instruments
Read the detailed description
Glaucoma is a multifactorial optic neuropathy characterized by structural damage of retinal ganglion cells (RGCs) and their axons that is associated with vision loss and may lead to irreversible blindness. Because glaucomatous damage is irreversible and effective treatment is available to halt further damage, glaucoma management should be optimized with precise micrometer-scale quantifications of ocular structures that improve detection of the disease and its progression. The introduction of OCT technology more than 20 years ago provided in vivo detailed visualization of the optic nerve head (ONH) and retina and enabled the quantitative evaluation of these tructures. Circumpapillary retinal nerve fiber layer (RNFL) thickness is a common OCT measurement that provides comprehensive evaluation of all RGCs in an eye as they converge into the ONH.
When measured with spectral-domain OCT, the RNFL has been shown to differentiate between healthy and glaucomatous eyes. The steady evolution of OCT technology has led to imaging with better resolution, higher scanning speeds, and advanced imaging patterns that has improved the reliability of OCT measurements and allowed for detection of minute changes that can improve the sensitivity of progression detection. Assessment of glaucoma progression usually is based on event or trend analysis. Event-based progression determines when a measurement exceeds a pre-established threshold for change from baseline. Trend-based analysis quantifies the rate of a parameter's progression over time.
- Conditions
- Glaucoma Open-Angle
- Keywords
- Glaucoma, OCT
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Primary Open Angle Glaucoma | 1. Patients older than 18 years of age with primary open-angle glaucoma (POAG) 2. POAG diagnosed on the basis of IOP measurements more than 21 mmHg, Open angle on gonioscopy (Grade 3 or 4 on Schaffer grading system for angle width), glaucomatous visual field defects consistent with glaucomatous optic disc changes. 3. Eyes with baseline macular and ONH OCT images and ONH photographs of adequate quality and r performed within 6 months of each other were selected |
What is being measured
The primary outcome is the main question the study is designed to answer.
OCT structural parameters
RNFL in (um), ONH in (um), as well as the inner macula thickness (in um) using spectral domain OCT
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start1 Jan 2022
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma Open-AngleStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Prospective
- Enrolment
- 1,584 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Abdelazeem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06434155
- Sponsor's protocol ID
- 17200545
- Acronym
- OCT
- Status last verified
- May 2024
- First submitted
- 20 May 2024
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social History and Glaucoma Progression: The Effect of Body Mass Index, Tobacco, and Alcohol Consumption on the Rates of Structural Change in Patients With Open Angle Glaucoma
- ClinicalTrials.gov ID
- NCT06434155
- Acronym / sponsor ID
- OCT / 17200545
- Conditions
- Glaucoma Open-Angle
- Keywords
- Glaucoma, OCT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,584 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 30 May 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 objective of this study is to predict of glaucoma progression. By imaging of the retinal nerve fiber layer RNFL, optic nerve head (ONH) and macular measurements using spectral-domain OCT (SD-OCT) instruments
Detailed description
Glaucoma is a multifactorial optic neuropathy characterized by structural damage of retinal ganglion cells (RGCs) and their axons that is associated with vision loss and may lead to irreversible blindness. Because glaucomatous damage is irreversible and effective treatment is available to halt further damage, glaucoma management should be optimized with precise micrometer-scale quantifications of ocular structures that improve detection of the disease and its progression. The introduction of OCT technology more than 20 years ago provided in vivo detailed visualization of the optic nerve head (ONH) and retina and enabled the quantitative evaluation of these tructures. Circumpapillary retinal nerve fiber layer (RNFL) thickness is a common OCT measurement that provides comprehensive evaluation of all RGCs in an eye as they converge into the ONH.
When measured with spectral-domain OCT, the RNFL has been shown to differentiate between healthy and glaucomatous eyes. The steady evolution of OCT technology has led to imaging with better resolution, higher scanning speeds, and advanced imaging patterns that has improved the reliability of OCT measurements and allowed for detection of minute changes that can improve the sensitivity of progression detection. Assessment of glaucoma progression usually is based on event or trend analysis. Event-based progression determines when a measurement exceeds a pre-established threshold for change from baseline. Trend-based analysis quantifies the rate of a parameter's progression over time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary Open Angle Glaucoma | – | –1. Patients older than 18 years of age with primary open-angle glaucoma (POAG) 2. POAG diagnosed on the basis of IOP measurements more than 21 mmHg, Open angle on gonioscopy (Grade 3 or 4 on Schaffer grading system for angle width), glaucomatous visual field defects consistent with glaucomatous optic disc changes. 3. Eyes with baseline macular and ONH OCT images and ONH photographs of adequate quality and r performed within 6 months of each other were selected |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients older than 18 years of age with primary open-angle glaucoma (OAG)
Key inclusion criteria (4 listed)
- IOP measurements more than 21 mmHg
- Open angle on gonioscopy (Grade 3 or 4 on Schaffer grading system for angle width)
- Glaucomatous visual field defects consistent with glaucomatous optic disc changes.
- Eyes with baseline macular and ONH OCT images and ONH photograps
Key exclusion criteria (5 listed)
- Participants with significant retinal disease.
- non-glaucomatous optic neuropathy.
- anomalous discs
- any retinal pathology.
- history of cataract or glaucoma surgery will not be exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
OCT structural parameters
Time frame: 6 months
RNFL in (um), ONH in (um), as well as the inner macula thickness (in um) using spectral domain OCT
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 30 May 2024.
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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 Open-Angle, run by Assiut 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 4 inclusion and 5 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 30 May 2024. 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?
OCT structural parameters (time frame: 6 months). 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 30 May 2024.