Retinal VascularNCT04928196
Retinal Microvasculature Before and After Silicone Oil by OCTA
An observational study of Retinal Vascular, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Prospective study to assess the retinal microvasculature, optic nerve head vasculature and retinal sensitivity using OCTA and microperimetry before and after silicone oil removal. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Retinal Vascular
- What is being tested?
- Microperimtery and optical coherence tomography angiography OCTA
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jul 2021to 15 Oct 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Prospective observational case series of patients before and after silicone oil removal
Who may be able to join
- 30 eyes of 30 patients with silicone oil tamponade will be evaluated before and after silicone oil removal
Who cannot join
- Proliferative diabetic retinopathy, recurrent detachment or macular hole
- Patients with chorioretinal degenerations involving the macula
- Secondary complications as cataract, silicone oil emulsification, or secondary glaucoma
- Media opacity hindering proper imaging
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Retinal Microvasculature Before and After Silicone Oil Removal by Optical Coherence Tomography Angiography
Prospective study to assess the retinal microvasculature, optic nerve head vasculature and retinal sensitivity using OCTA and microperimetry before and after silicone oil removal.
Read the detailed description
Prospective study to assess the retinal microvasculature, optic nerve head vasculature and retinal sensitivity using OCTA and microperimetry before and after silicone oil removal.
The study includes 30 patients with silicone oil tamponade will be evaluated before and after silicone oil removal
- Conditions
- Retinal Vascular
- Being tested
- Microperimtery and optical coherence tomography angiography OCTA
- Keywords
- retinal microvasculature, microperimtry, OCTA, Silicone oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microperimtery and optical coherence tomography angiography OCTAOther
observational: Investigations are done to assess the retinal microvasculature and function before and after silicone oil removal
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular and optic nerve head vascular density
Using OCTA to assess vascular density changes of the macula and optic nerve head before and after silicone oil removal
Measured: one year
Retinal sensitivity by microperimetry
Using microperimetry to assess the retinal sensitivity changes before and after silicone oil removal
Measured: one year
Secondary outcomes (3)
Retinal vascular density and best corrected visual acuity
Correlate the change in the retinal vascular density with best corrected visual acuity
Measured: one year
Optic nerve head vascular density and best corrected visual acuity
Correlate the change in the optic nerve head vascular density with best corrected visual acuity
Measured: one year
Retinal sensitivity and best corrected visual acuity
Correlate the change in the retinal sensitivity with best corrected visual acuity
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start12 Jul 2021
- Primary completion30 Jun 2022
- Study completion15 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retinal VascularStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hebatalla Makled, Kasr El Aini Hospital
- Investigators
- Hebatalla S. Makled, MD, Principal investigator, Kasr El Aini HospitalGhada A. Nassar, MD, Principal investigator, Kasr El Aini HospitalMaha M. Youssef, MD, Principal investigator, Kasr El Aini HospitalLameece M. Hassan, MD, Principal investigator, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04928196
- Sponsor's protocol ID
- 6-1-2021-1
- Status last verified
- Mar 2023
- First submitted
- 5 Jun 2021
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nassar GA, Makled HS, Youssef MM, Hassan LM. Functional and perfusion changes associated with silicone oil tamponade after macula-off rhegmatogenous retinal detachment surgery: an optical coherence tomography angiography/microperimetry study. Int Ophthalmol. 2024 Feb 22;44(1):107. doi: 10.1007/s10792-024-03037-5.
PubMed 38386180
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Retinal Microvasculature Before and After Silicone Oil Removal by Optical Coherence Tomography Angiography
- ClinicalTrials.gov ID
- NCT04928196
- Acronym / sponsor ID
- 6-1-2021-1
- Conditions
- Retinal Vascular
- Keywords
- retinal microvasculature, microperimtry, OCTA, Silicone oil
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 15 Oct 2022 (actual)
- First posted
- 16 Jun 2021 (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.
Prospective study to assess the retinal microvasculature, optic nerve head vasculature and retinal sensitivity using OCTA and microperimetry before and after silicone oil removal.
Detailed description
Prospective study to assess the retinal microvasculature, optic nerve head vasculature and retinal sensitivity using OCTA and microperimetry before and after silicone oil removal.
The study includes 30 patients with silicone oil tamponade will be evaluated before and after silicone oil removal
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Prospective observational case series of patients before and after silicone oil removal
Key inclusion criteria (1 listed)
- 30 eyes of 30 patients with silicone oil tamponade will be evaluated before and after silicone oil removal
Key exclusion criteria (4 listed)
- Proliferative diabetic retinopathy, recurrent detachment or macular hole
- Patients with chorioretinal degenerations involving the macula
- Secondary complications as cataract, silicone oil emulsification, or secondary glaucoma
- Media opacity hindering proper imaging
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 |
|---|---|---|
| Microperimtery and optical coherence tomography angiography OCTAobservational: Investigations are done to assess the retinal microvasculature and function before and after silicone oil removal | Other | – |
Primary outcome
Macular and optic nerve head vascular density
Time frame: one year
Using OCTA to assess vascular density changes of the macula and optic nerve head before and after silicone oil removal
Retinal sensitivity by microperimetry
Time frame: one year
Using microperimetry to assess the retinal sensitivity changes before and after silicone oil removal
3 secondary outcomes
Retinal vascular density and best corrected visual acuity
Time frame: one year
Optic nerve head vascular density and best corrected visual acuity
Time frame: one year
Retinal sensitivity and best corrected visual acuity
Time frame: one year
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 14 Mar 2023.
- Derived from this study: PubMed 38386180Nassar GA, Makled HS, Youssef MM, Hassan LM. Functional and perfusion changes associated with silicone oil tamponade after macula-off rhegmatogenous retinal detachment surgery: an optical coherence tomography angiography/microperimetry study. Int Ophthalmol. 2024 Feb 22;44(1):107. doi: 10.1007/s10792-024-03037-5.
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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.
Hebatalla S. Makled, MD principal investigator
Kasr El Aini Hospital
Ghada A. Nassar, MD principal investigator
Kasr El Aini Hospital
Maha M. Youssef, MD principal investigator
Kasr El Aini 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 Retinal Vascular, run by Kasr El Aini Hospital 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 4 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 14 Mar 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?
Macular and optic nerve head vascular density (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04928196, which also lists 1 linked publication.
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 14 Mar 2023.