Rhegmatogenous Macula-off Retinal DetachmentEndotheliumNCT07418606
Corneal Endothelial Cell Changes In Silicon Filled Eye
An observational study of Rhegmatogenous Macula-off Retinal Detachment, run by Minia University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate corneal endothelial cell changes after pars plana vitrectomy in Rhegmatogenous Retinal detachment , compare the results using different silicon oil viscositites , and assess whether these changes are reversible after silicone removal or not . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rhegmatogenous Macula-off Retinal Detachment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2025to 20 Sep 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with Rhegmatodenous retinal detachment which need PPV will be included in this study.
Who may be able to join
- All patients with Rhegmatodenous retinal detachment which need PPV will be included in this study.
Who cannot join
- Patients with corneal dystrophies or degeneration.
- Patients with a history of refractive surgery, either corneal or phakic lOL implantation.
- Patients with a history of keratoplasty.
- Patients with history of retinal detachment surgery in the same eye.
- Recurrent cases during the follow-up period will be removed from the study. 6. patients with gas tamponade 7. patients with silicon oil 1000 cs 8. patients with Retinal pathologies such as macular hole , diabetic changes 9. patients undergo phacovitrectomy
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate corneal endothelial cell changes after pars plana vitrectomy in Rhegmatogenous Retinal detachment , compare the results using different silicon oil viscositites , and assess whether these changes are reversible after silicone removal or not .
Read the detailed description
The aim of this study is to evaluate corneal endothelial cell changes after pars plana vitrectomy in Rhegmatogenous Retinal detachment , compare the results using different silicon oil viscositites , and assess whether these changes are reversible after silicone removal or not .
- Keywords
- Endothelial cells, Silicone oil
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 |
|---|---|---|
| Corneal Endothelial Cell Changes In Silicon 2000 cTs Filled Eye . | study of Corneal Endothelial Cell Changes In Silicon 2000 cTs Filled Eye . | |
| Corneal Endothelial Cell Changes In Silicon 5000 cs Filled Eye . | study of Corneal Endothelial Cell Changes In Silicon 5000 cs Filled Eye . |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal Endothelial Cell Changes In Silicon Filled Eye .
Corneal Endothelial Cell Changes cell density ( cells/ mm) , coeffient variation(%) In Silicon Filled Eye at 1 and 3 months postoperative
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start15 Jun 2025
- Primary completion15 Aug 2026 (estimated)
- Study completion20 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhegmatogenous Macula-off Retinal DetachmentStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Abdelhamid, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07418606
- Sponsor's protocol ID
- 1564/6/2025.
- Acronym
- Endothelium
- Status last verified
- Jun 2025
- First submitted
- 9 Jan 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corneal Endothelial Cell Changes In Silicon Filled Eye
- ClinicalTrials.gov ID
- NCT07418606
- Acronym / sponsor ID
- Endothelium / 1564/6/2025.
- Keywords
- Endothelial cells, Silicone oil
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 20 Sep 2026 (estimated)
- First posted
- 18 Feb 2026 (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 aim of this study is to evaluate corneal endothelial cell changes after pars plana vitrectomy in Rhegmatogenous Retinal detachment , compare the results using different silicon oil viscositites , and assess whether these changes are reversible after silicone removal or not .
Detailed description
The aim of this study is to evaluate corneal endothelial cell changes after pars plana vitrectomy in Rhegmatogenous Retinal detachment , compare the results using different silicon oil viscositites , and assess whether these changes are reversible after silicone removal or not .
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corneal Endothelial Cell Changes In Silicon 2000 cTs Filled Eye . | – | –study of Corneal Endothelial Cell Changes In Silicon 2000 cTs Filled Eye . |
| Corneal Endothelial Cell Changes In Silicon 5000 cs Filled Eye . | – | –study of Corneal Endothelial Cell Changes In Silicon 5000 cs Filled Eye . |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with Rhegmatodenous retinal detachment which need PPV will be included in this study.
Key inclusion criteria (1 listed)
- All patients with Rhegmatodenous retinal detachment which need PPV will be included in this study.
Key exclusion criteria (5 listed)
- Patients with corneal dystrophies or degeneration.
- Patients with a history of refractive surgery, either corneal or phakic lOL implantation.
- Patients with a history of keratoplasty.
- Patients with history of retinal detachment surgery in the same eye.
- Recurrent cases during the follow-up period will be removed from the study. 6. patients with gas tamponade 7. patients with silicon oil 1000 cs 8. patients with Retinal pathologies such as macular hole , diabetic changes 9. patients undergo phacovitrectomy
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
Corneal Endothelial Cell Changes In Silicon Filled Eye .
Time frame: 4 months
Corneal Endothelial Cell Changes cell density ( cells/ mm) , coeffient variation(%) In Silicon Filled Eye at 1 and 3 months postoperative
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 30 Jun 2026.
- 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. 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 Rhegmatogenous Macula-off Retinal Detachment, run by Minia 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 1 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: under way, not looking for participants, as of the sponsor's last update on 30 Jun 2026. 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?
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?
Corneal Endothelial Cell Changes In Silicon Filled Eye . (time frame: 4 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 Jun 2026.