Non-arteritic Ischemic Optic NeuropathyNCT06031350
Peripapillary and Macular Vascular Changes of Unilateral Anterior Ischemic Optic Neuropathy: An Optical Coherence Tomography Angiography Study
An observational study of Non-arteritic Ischemic Optic Neuropathy, run by Omar Said at 1 site in Egypt.
Trial summary
This series aims at studying the peripapillary and macular vascular changes in subjects with unilateral anterior ischemic optic neuropathy via Optical Coherence Tomography Angiography (OCTA). Read more about this study
- Who is it for?
- Ages Up to 40 years
- Conditions the study is for
- Non-arteritic Ischemic Optic Neuropathy
- What is being tested?
- Optical Coherence Tomography Angiography
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 30 Jun 2022
- How long will I take part?
- 3 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 Up to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients presenting to the outpatient clinic of the department of Ophthalmology in Fayoum university hospitals with unilateral acute NAION. 30 patients (60 eyes) divided into 2 groups: 30 NAION eyes as the case group, and 30 fellow eyes as a control group.
Who may be able to join
- Patients diagnosed with unilateral NAION and acute or sudden painless drop of vision.
- A normal fellow eye.
- Age ≥ 40 years old.
Who cannot join
- Arteritic type of AION.
- NAION patients in chronic phase.
- Acute phase NAION patients with any other optic neuropathy in the other eye.
- Eyes with opaque media.
- Elevated intraocular pressure (>22 mmHg).
- Refractive errors greater than 6 diopters of spherical equivalent.
- Poor cooperation with fixation or the OCTA examination.
Trial locations and contacts
1 site in 1 country.
About this study
This series aims at studying the peripapillary and macular vascular changes in subjects with unilateral anterior ischemic optic neuropathy via Optical Coherence Tomography Angiography (OCTA).
Read the detailed description
After approval of the local institutional ethics committee and local institutional review board, This study was conducted upon 30 patients diagnosed with acute NAION attending at Ophthalmology outpatient clinic in Fayoum University Hospitals. The participants were informed about the objectives of the study, the examination, investigations and the confidentiality of their information and their right not to participate in the study. OCT and OCTA was done for all subjects and control group with Optovue, Inc., Fremont, CA, USA. Patients were examined on presentation, after 6 weeks and lastly after 3 months. OCT was used for evaluation of Central macular thickness (CMT), nerve fiber layer thickness (NFLT) and ganglion cell complex (GCC). OCTA was done for quantitative evaluation of vessel density in the following: optic nerve head and peripapillary area, macular superficial vessel density, macular deep vessel density and foveal avascular zone. Vessel density was reported as the percentage of the total area that was occupied by blood vessels. All parameters were calculated automatically by the machine software. Poor quality scans and those with motion artifacts were excluded. Statistical analysis was performed using SPSS software (version 22; SPSS, Chicago, IL, USA). The data were presented as the mean ± SD values. P-value <0.05 was considered significant.
- Conditions
- Non-arteritic Ischemic Optic Neuropathy
- Being tested
- Optical Coherence Tomography Angiography
- Keywords
- OCTA AION NAION
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence Tomography AngiographyDiagnostic test
Optovue, Inc., Fremont, CA, USA
| Study group | Role | What they receive |
|---|---|---|
| Diseased eyes | The 30 diseased eyes of the patients were considered the case group. Receives: Diagnostic Test: Optical Coherence Tomography Angiography | |
| Fellow eyes | The 30 fellow eyes of the patients were considered the control group. Receives: Diagnostic Test: Optical Coherence Tomography Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripapillary and macular vascular changes
comparing vessel density in different areas and sectors of diseased and fellow eyes
Measured: 3 months (0,6,12 weeks)
Secondary outcomes (1)
Thickness of different retinal layers
comparing thickness of Central macular thickness (CMT), nerve fiber layer thickness (NFLT) and ganglion cell complex (GCC)
Measured: 3 months (0,6,12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start1 Jun 2021
- Primary completion31 May 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-arteritic Ischemic Optic NeuropathyStudies 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
- 30 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Omar Said
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Omar Said, Fayoum University
- Investigators
- Omar Said, MD, Study director, Assistant professor of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06031350
- Sponsor's protocol ID
- EOM64
- Status last verified
- Sep 2023
- First submitted
- 2 Sep 2023
- Last updated
- 11 Sep 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 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripapillary and Macular Vascular Changes of Unilateral Anterior Ischemic Optic Neuropathy: An Optical Coherence Tomography Angiography Study
- ClinicalTrials.gov ID
- NCT06031350
- Acronym / sponsor ID
- EOM64
- Conditions
- Non-arteritic Ischemic Optic Neuropathy
- Keywords
- OCTA AION NAION
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Omar SaidUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 11 Sep 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 series aims at studying the peripapillary and macular vascular changes in subjects with unilateral anterior ischemic optic neuropathy via Optical Coherence Tomography Angiography (OCTA).
Detailed description
After approval of the local institutional ethics committee and local institutional review board, This study was conducted upon 30 patients diagnosed with acute NAION attending at Ophthalmology outpatient clinic in Fayoum University Hospitals. The participants were informed about the objectives of the study, the examination, investigations and the confidentiality of their information and their right not to participate in the study. OCT and OCTA was done for all subjects and control group with Optovue, Inc., Fremont, CA, USA. Patients were examined on presentation, after 6 weeks and lastly after 3 months. OCT was used for evaluation of Central macular thickness (CMT), nerve fiber layer thickness (NFLT) and ganglion cell complex (GCC). OCTA was done for quantitative evaluation of vessel density in the following: optic nerve head and peripapillary area, macular superficial vessel density, macular deep vessel density and foveal avascular zone. Vessel density was reported as the percentage of the total area that was occupied by blood vessels. All parameters were calculated automatically by the machine software. Poor quality scans and those with motion artifacts were excluded. Statistical analysis was performed using SPSS software (version 22; SPSS, Chicago, IL, USA). The data were presented as the mean ± SD values. P-value <0.05 was considered significant.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diseased eyes | – | Diagnostic Test: Optical Coherence Tomography AngiographyThe 30 diseased eyes of the patients were considered the case group. |
| Fellow eyes | – | Diagnostic Test: Optical Coherence Tomography AngiographyThe 30 fellow eyes of the patients were considered the control group. |
Who may qualify
- Ages
- Up to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients presenting to the outpatient clinic of the department of Ophthalmology in Fayoum university hospitals with unilateral acute NAION. 30 patients (60 eyes) divided into 2 groups: 30 NAION eyes as the case group, and 30 fellow eyes as a control group.
Key inclusion criteria (3 listed)
- Patients diagnosed with unilateral NAION and acute or sudden painless drop of vision.
- A normal fellow eye.
- Age ≥ 40 years old.
Key exclusion criteria (7 listed)
- Arteritic type of AION.
- NAION patients in chronic phase.
- Acute phase NAION patients with any other optic neuropathy in the other eye.
- Eyes with opaque media.
- Elevated intraocular pressure (>22 mmHg).
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 AngiographyOptovue, Inc., Fremont, CA, USA | Diagnostic test | Diseased eyes, Fellow eyes |
Primary outcome
Peripapillary and macular vascular changes
Time frame: 3 months (0,6,12 weeks)
comparing vessel density in different areas and sectors of diseased and fellow eyes
1 secondary outcome
Thickness of different retinal layers
Time frame: 3 months (0,6,12 weeks)
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 11 Sep 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.
Omar Said, MD study director
Assistant professor of Ophthalmology
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 Non-arteritic Ischemic Optic Neuropathy, 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 3 inclusion and 7 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 11 Sep 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?
Peripapillary and macular vascular changes (time frame: 3 months (0,6,12 weeks)). 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 11 Sep 2023.