Optical Coherence Tomography (OCT)NCT06886893
Optical Coherence Tomography in Retinal Vein Occlusion
An observational study of Optical Coherence Tomography (OCT), run by Assiut University.
Trial summary
This study aims to evaluate how optical coherence tomography (OCT) can help predict outcomes in patients with retinal vein occlusion (RVO), a condition that affects blood flow in the retina. RVO can cause macular edema, which is swelling in the part of the eye responsible for central vision. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Optical Coherence Tomography (OCT)
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: patients with retinal vein occlusion (RVO), a condition that affects blood flow in the retina. RVO can cause macular edema, which is swelling in the part of the eye responsible for central vision. Adults aged 18 or older with branch or central retinal vein occlusion. Patients must have macular edema confirmed by OCT and no previous RVO in the affected eye.
Who may be able to join
- Adults aged 18 years or older.
- Patients diagnosed with branch or central retinal vein occlusion.
- Patients with macular edema confirmed by OCT due to vein occlusion.
- Patients with no prior history of RVO in the affected eye.
Who cannot join
- Presence of other retinal diseases that could affect OCT interpretation (e.g., diabetic retinopathy, age-related macular degeneration).
- History of intraocular surgery within the last three months.
- Presence of significant media opacities (e.g., dense cataract, vitreous hemorrhage) that interfere with OCT imaging.
About this study
Official title: Optical Coherence Tomography Data As a Prognostic Indicator in Retinal Vein Occlusion
This study aims to evaluate how optical coherence tomography (OCT) can help predict outcomes in patients with retinal vein occlusion (RVO), a condition that affects blood flow in the retina. RVO can cause macular edema, which is swelling in the part of the eye responsible for central vision. The study will use OCT scans to assess changes in the retina and how these changes relate to vision improvement over time.
Read the detailed description
Objectives Evaluate how OCT data can predict visual outcomes by analyzing retinal changes and macular edema characteristics.
Assess the correlation between baseline OCT biomarkers and visual acuity improvements over time.
Study Design Type: Cross-sectional study.
Setting: Conducted at several eye care centers in Egypt.
Participants Inclusion Criteria: Adults with branch or central RVO, macular edema confirmed by OCT, and no prior RVO in the affected eye.
Exclusion Criteria: Other retinal diseases, recent intraocular surgery, or significant media opacities.
Procedures Informed Consent and History Taking.
Ophthalmologic Examination: Includes BCVA, IOP, slit-lamp biomicroscopy, and fundus examination.
OCT Imaging: Using NIDEK RS-330 Retina scan duo 2 (SD-OCT) to assess macular changes.
OCT Image Evaluation: Classification of macular edema types and assessment of biomarkers like subretinal fluid and cystoid changes.
- Conditions
- Optical Coherence Tomography (OCT)
- Keywords
- OCT, retinal vein occlusion
- Medical subject headings
- Retinal Vein Occlusion
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 |
|---|---|---|
| Adults with branch or central RVO, macular edema confirmed by OCT, and no prior RVO in the affected | Adults aged 18 years or older. Patients diagnosed with branch or central retinal vein occlusion. Patients with macular edema confirmed by OCT due to vein occlusion. Patients with no prior history of RVO in the affected eye. |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in OCT biomarkers and visual acuity post-treatment.
Correlation between baseline OCT biomarkers and visual acuity at presentation after 1, 3, and 6 months post-treatment.
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 posted20 Mar 2025
- Study start1 May 2025 (estimated)
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optical Coherence Tomography (OCT)Studies 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
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mayar Adel Francis, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06886893
- Sponsor's protocol ID
- OCT in retinal vein occlusion
- Status last verified
- Mar 2025
- First submitted
- 15 Mar 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography Data As a Prognostic Indicator in Retinal Vein Occlusion
- ClinicalTrials.gov ID
- NCT06886893
- Acronym / sponsor ID
- OCT in retinal vein occlusion
- Conditions
- Optical Coherence Tomography (OCT)
- Keywords
- OCT, retinal vein occlusion
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 20 Mar 2025 (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 study aims to evaluate how optical coherence tomography (OCT) can help predict outcomes in patients with retinal vein occlusion (RVO), a condition that affects blood flow in the retina. RVO can cause macular edema, which is swelling in the part of the eye responsible for central vision. The study will use OCT scans to assess changes in the retina and how these changes relate to vision improvement over time.
Detailed description
Objectives Evaluate how OCT data can predict visual outcomes by analyzing retinal changes and macular edema characteristics.
Assess the correlation between baseline OCT biomarkers and visual acuity improvements over time.
Study Design Type: Cross-sectional study.
Setting: Conducted at several eye care centers in Egypt.
Participants Inclusion Criteria: Adults with branch or central RVO, macular edema confirmed by OCT, and no prior RVO in the affected eye.
Exclusion Criteria: Other retinal diseases, recent intraocular surgery, or significant media opacities.
Procedures Informed Consent and History Taking.
Ophthalmologic Examination: Includes BCVA, IOP, slit-lamp biomicroscopy, and fundus examination.
OCT Imaging: Using NIDEK RS-330 Retina scan duo 2 (SD-OCT) to assess macular changes.
OCT Image Evaluation: Classification of macular edema types and assessment of biomarkers like subretinal fluid and cystoid changes.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with branch or central RVO, macular edema confirmed by OCT, and no prior RVO in the affected | – | –Adults aged 18 years or older. Patients diagnosed with branch or central retinal vein occlusion. Patients with macular edema confirmed by OCT due to vein occlusion. Patients with no prior history of RVO in the affected eye. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with retinal vein occlusion (RVO), a condition that affects blood flow in the retina. RVO can cause macular edema, which is swelling in the part of the eye responsible for central vision. Adults aged 18 or older with branch or central retinal vein occlusion. Patients must have macular edema confirmed by OCT and no previous RVO in the affected eye.
Key inclusion criteria (4 listed)
- Adults aged 18 years or older.
- Patients diagnosed with branch or central retinal vein occlusion.
- Patients with macular edema confirmed by OCT due to vein occlusion.
- Patients with no prior history of RVO in the affected eye.
Key exclusion criteria (3 listed)
- Presence of other retinal diseases that could affect OCT interpretation (e.g., diabetic retinopathy, age-related macular degeneration).
- History of intraocular surgery within the last three months.
- Presence of significant media opacities (e.g., dense cataract, vitreous hemorrhage) that interfere with OCT imaging.
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
changes in OCT biomarkers and visual acuity post-treatment.
Time frame: 6 months
Correlation between baseline OCT biomarkers and visual acuity at presentation after 1, 3, and 6 months post-treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Optical Coherence Tomography (OCT), run by Assiut University.
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 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: opening soon, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
changes in OCT biomarkers and visual acuity post-treatment. (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 20 Mar 2025.