Retinal DiseaseNCT05699096
Perfluorooctyl Bromide Which Empowers the Liquid to Flat the Detached Retina and Displace the Underneath Fluids Anteriorly
An observational study of Retinal Disease, run by EL Romany Ophthalmics Factory at 1 site in Egypt.
Trial summary
Perfluorohexyloctaneis Essential for Repositioning Giant Retinal Breaks and Can be Used for Removal of Subretinal Fluid as Well as Stabilization of the Retina to Offset Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Retinal Disease
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 1 Jul 2026
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: primary care clinic
Who may be able to join
- - Is 20 years or older Has been diagnosed with Keratoconus; Has no other active ocular disease; Is not pregnant or nursing;
Who cannot join
- Is under the age of 20 Has best corrected visual acuity outside 20/400; Pregnant or nursing at the time of enrollment in the study;
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Girgis Boules
Cairo, Kubri EL Kubba, 11711
Girgis Boules, elromanyophthalmics@gmail.com
About this study
Official title: Perfluorooctyl Bromideessential for Repositioning Giant Retinal Breaks and Can be Used for Removal of Subretinal Fluid as Well as Stabilization of the Retina to Offset
Perfluorohexyloctaneis Essential for Repositioning Giant Retinal Breaks and Can be Used for Removal of Subretinal Fluid as Well as Stabilization of the Retina to Offset
- Conditions
- Retinal Disease
- Medical subject headings
- Retinal Diseases
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 |
|---|---|---|
| eye surgery ,Vitreoretinal Surgery and Related Ocular Inflammation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
flat the detached retina and displace the underneath fluids anteriorly
the effect of Perfluorooctyl Bromide on the retina ,under ophthalmic microscope check the flatted retina
Measured: Base line
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start1 Sep 2024 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DiseaseStudies 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
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EL Romany Ophthalmics Factory
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05699096
- Sponsor's protocol ID
- ROPFO
- Status last verified
- Jun 2024
- First submitted
- 15 Jan 2023
- Last updated
- 3 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perfluorooctyl Bromideessential for Repositioning Giant Retinal Breaks and Can be Used for Removal of Subretinal Fluid as Well as Stabilization of the Retina to Offset
- ClinicalTrials.gov ID
- NCT05699096
- Acronym / sponsor ID
- ROPFO
- Conditions
- Retinal Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- EL Romany Ophthalmics FactoryIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 26 Jan 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.
Perfluorohexyloctaneis Essential for Repositioning Giant Retinal Breaks and Can be Used for Removal of Subretinal Fluid as Well as Stabilization of the Retina to Offset
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| eye surgery ,Vitreoretinal Surgery and Related Ocular Inflammation | – | – |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- primary care clinic
Key inclusion criteria (1 listed)
- - Is 20 years or older Has been diagnosed with Keratoconus; Has no other active ocular disease; Is not pregnant or nursing;
Key exclusion criteria (1 listed)
- Is under the age of 20 Has best corrected visual acuity outside 20/400; Pregnant or nursing at the time of enrollment in the study;
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
flat the detached retina and displace the underneath fluids anteriorly
Time frame: Base line
the effect of Perfluorooctyl Bromide on the retina ,under ophthalmic microscope check the flatted retina
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 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.
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 Disease, run by EL Romany Ophthalmics Factory 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 1 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: status not confirmed, as of the sponsor's last update on 3 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact El R Ophthalmics (+201212331343, drmina@elromanyophthalmics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
flat the detached retina and displace the underneath fluids anteriorly (time frame: Base line). 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 3 Jul 2024.