Endophthalmitis Following Cataract SurgeryEndopthalmitisNCT06990607
Compare PPV With and Without Silicone Oil in Managing Postoperative Endophthalmitis
A study testing Pars plana Vitrectomy and Silicone Oil in people with Endophthalmitis Following Cataract Surgery, run by Benha University at 1 site in Egypt.
Trial summary
Comparing PPV with and without silicone oil in managing postoperative endophthalmitis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endophthalmitis Following Cataract Surgery
- What is being tested?
- Pars plana Vitrectomy and Silicone Oil
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2024to 1 Dec 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients (≥ 18 years) presenting with clinical manifestations of endophthalmitis after cataract surgery
Who cannot join
- patients with concurrent ocular or systemic conditions that could potentially confound study outcomes, such as active retinal diseases unrelated to endophthalmitis
- pre-existing poor visual prognosis due to conditions like advanced glaucoma or macular degeneration, or prior ocular surgery affecting the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pars Plana Vitrectomy With Silicone Oil Versus Pars Plana Vitrectomy Alone in the Management of Postoperative Endophthalmitis
Comparing PPV with and without silicone oil in managing postoperative endophthalmitis
Read the detailed description
The objective of this study is to compare the outcomes of PPV with silicone oil tamponade to PPV alone in patients with postoperative endophthalmitis by assessing visual acuity, and postoperative complications such as rhegmatogenous retinal detachment (RRD).
- Being tested
- Pars plana Vitrectomy, Silicone Oil
- Keywords
- Postoperative endophthalmitis, pars plana vitrectomy, silicone oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pars plana VitrectomyProcedure or surgery
Pars plana Vitrectomy using 23 Gauge
Silicone OilProcedure or surgery
Silicone Oil injection after PPV
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | Pars plana Vitrectomy Alone Receives: Procedure: Pars plana Vitrectomy |
| Group II | Active comparator | Pars plana Vitrectomy with Silicone Oil Receives: Procedure: Pars plana Vitrectomy; Procedure: Silicone Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual acuity, with best-corrected visual acuity (BCVA) recorded using LogMAR
log-MAR value (log of the minimum angle of resolution). Normal visual acuity for most adults is approximately -0.1 on this scale, which is equivalent to 20/16 on a Snellen visual acuity chart.
Measured: 1, 2, 4, and 12 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start20 Jan 2024
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endophthalmitis Following Cataract SurgeryStudies of the same condition, open and under way.
- More trials run by Benha 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab Mohamed Elsayed Mohamed Saad, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06990607
- Sponsor's protocol ID
- Endophthalmitis and silicone
- Acronym
- Endopthalmitis
- Status last verified
- May 2025
- First submitted
- 17 May 2025
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pars Plana Vitrectomy With Silicone Oil Versus Pars Plana Vitrectomy Alone in the Management of Postoperative Endophthalmitis
- ClinicalTrials.gov ID
- NCT06990607
- Acronym / sponsor ID
- Endopthalmitis / Endophthalmitis and silicone
- Keywords
- Postoperative endophthalmitis, pars plana vitrectomy, silicone oil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 20 Jan 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 25 May 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.
Comparing PPV with and without silicone oil in managing postoperative endophthalmitis
Detailed description
The objective of this study is to compare the outcomes of PPV with silicone oil tamponade to PPV alone in patients with postoperative endophthalmitis by assessing visual acuity, and postoperative complications such as rhegmatogenous retinal detachment (RRD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Procedure: Pars plana VitrectomyPars plana Vitrectomy Alone |
| Group II | Active comparator | Procedure: Pars plana Vitrectomy, Procedure: Silicone OilPars plana Vitrectomy with Silicone Oil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients (≥ 18 years) presenting with clinical manifestations of endophthalmitis after cataract surgery
Key exclusion criteria (2 listed)
- patients with concurrent ocular or systemic conditions that could potentially confound study outcomes, such as active retinal diseases unrelated to endophthalmitis
- pre-existing poor visual prognosis due to conditions like advanced glaucoma or macular degeneration, or prior ocular surgery affecting 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pars plana VitrectomyPars plana Vitrectomy using 23 Gauge | Procedure or surgery | Group I, Group II |
| Silicone OilSilicone Oil injection after PPV | Procedure or surgery | Group II |
Primary outcome
visual acuity, with best-corrected visual acuity (BCVA) recorded using LogMAR
Time frame: 1, 2, 4, and 12 weeks postoperatively
log-MAR value (log of the minimum angle of resolution). Normal visual acuity for most adults is approximately -0.1 on this scale, which is equivalent to 20/16 on a Snellen visual acuity chart.
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 25 May 2025.
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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?
A study testing Pars plana Vitrectomy and Silicone Oil in people with Endophthalmitis Following Cataract Surgery, run by Benha 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 2 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 25 May 2025. 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?
visual acuity, with best-corrected visual acuity (BCVA) recorded using LogMAR (time frame: 1, 2, 4, and 12 weeks postoperatively). 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 25 May 2025.