EndophthalmitisNCT07717944
Phacovitrectomy Versus Pars Plana Vitrectomy Alone for Post-Intravitreal Injection Endophthalmitis
A study testing Phacovitrectomy and Pars plana vitrectomy in people with Endophthalmitis and Endophthalmitis Postoperative, run by Benha University at 1 site in Egypt.
Trial summary
This prospective comparative interventional study evaluated the anatomical and visual outcomes of phacovitrectomy versus pars plana vitrectomy (PPV) alone in patients with post-intravitreal injection endophthalmitis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Endophthalmitis, Endophthalmitis Postoperative, Intravitreal Injection Patients
- What is being tested?
- Phacovitrectomy and Pars plana vitrectomy
- 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
- 15 Jan 2024to 20 Jun 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- Clinical diagnosis of acute post-intravitreal injection infectious endophthalmitis.
- History of intravitreal injection before the onset of endophthalmitis.
- Phakic eye at the time of presentation.
- Eyes with persistent or worsening clinical signs despite initial intravitreal antibiotic therapy (vancomycin and ceftazidime), requiring surgical intervention.
- Underwent either combined phacovitrectomy or pars plana vitrectomy alone as the primary surgical treatment.
- Ability to complete at least 3 months of postoperative follow-up.
Who cannot join
- Endophthalmitis secondary to causes other than intravitreal injection (e.g., post-cataract surgery, glaucoma surgery, penetrating ocular trauma, or endogenous endophthalmitis).
- Previous vitrectomy in the study eye.
- Pre-existing ocular conditions likely to significantly affect visual outcomes, including retinal detachment, advanced optic neuropathy, advanced glaucoma, or dense corneal opacity.
- Eyes with no visual potential before the onset of endophthalmitis.
- Inability to complete the scheduled follow-up visits or missing primary outcome data.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes of Phacovitrectomy Versus Pars Plana Vitrectomy Alone in Patients With Post-Intravitreal Injection Endophthalmitis: A Retrospective Comparative Cohort Study
This prospective comparative interventional study evaluated the anatomical and visual outcomes of phacovitrectomy versus pars plana vitrectomy (PPV) alone in patients with post-intravitreal injection endophthalmitis. Eligible patients underwent either combined phacovitrectomy or PPV alone according to the study protocol. The primary outcome was the change in best-corrected visual acuity (BCVA) from baseline to 3 months after surgery. Secondary outcomes included postoperative complications, need for additional surgical intervention, resolution of intraocular inflammation, and restoration of media clarity.
Read the detailed description
Post-intravitreal injection endophthalmitis is a rare but vision-threatening complication that requires prompt surgical intervention to maximize visual recovery. Pars plana vitrectomy (PPV) is the standard surgical treatment for severe cases; however, whether combining cataract extraction with vitrectomy provides superior anatomical and functional outcomes remains uncertain.
This prospective comparative interventional study was conducted to compare phacovitrectomy with PPV alone in the management of post-intravitreal injection endophthalmitis. Consecutive eligible phakic patients presenting with post-intravitreal injection endophthalmitis were enrolled between 2024 and June 2026 and underwent one of the two surgical approaches according to the study protocol.
Baseline demographic and clinical data were collected, including age, sex, indication for the original intravitreal injection, presenting best-corrected visual acuity (BCVA), clinical findings, microbiological results, and the interval between symptom onset and surgery. Operative details and postoperative follow-up data were prospectively recorded.
The primary outcome measure was the change in BCVA (logMAR) from baseline to 3 months after surgery. Secondary outcome measures included postoperative complications (such as retinal detachment, hypotony, persistent corneal edema, and recurrent infection), the need for additional surgical interventions, resolution of intraocular inflammation, restoration of media clarity, and anatomical success.
Comparative analyses were performed between the two treatment groups using appropriate statistical methods. Multivariable analyses were used to adjust for potential confounding factors, including baseline visual acuity, microbiological culture results, and time from presentation to surgery. The study aimed to determine whether combined phacovitrectomy provides superior visual and anatomical outcomes compared with PPV alone in patients with post-intravitreal injection endophthalmitis.
- Being tested
- Phacovitrectomy, Pars plana vitrectomy
- Keywords
- Post-intravitreal injection endophthalmitis, Vitrectomy, Pars plana vitrectomy, Visual outcomes
- Medical subject headings
- Endophthalmitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhacovitrectomyProcedure or surgery
Also called Combined phacoemulsification and pars plana vitrectomy
Combined phacoemulsification with intraocular lens implantation and standard 23- or 25-gauge pars plana vitrectomy performed as the primary surgical treatment for post-intravitreal injection endophthalmitis. Vitrectomy included removal of vitreous opacities and inflammatory debris with intravitreal administration of antibiotics according to the study protocol.
Pars plana vitrectomyProcedure or surgery
Also called PPV
Standard 23- or 25-gauge pars plana vitrectomy performed as the primary surgical treatment for post-intravitreal injection endophthalmitis without simultaneous cataract extraction. Vitrectomy included removal of vitreous opacities and inflammatory debris with intravitreal administration of antibiotics according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Phacovitrectomy | Experimental | Twenty participants with post-intravitreal injection endophthalmitis underwent combined phacoemulsification with intraocular lens implantation and pars plana vitrectomy as the primary surgical treatment. Standard intravitreal antibiotics were administered according to the study protocol when indicated. Receives: Procedure: Phacovitrectomy |
| Pars Plana Vitrectomy Alone | Active comparator | Twenty participants with post-intravitreal injection endophthalmitis underwent pars plana vitrectomy alone as the primary surgical treatment. Standard intravitreal antibiotics were administered according to the study protocol when indicated. Receives: Procedure: Pars plana vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Best-Corrected Visual Acuity (BCVA)
Change in best-corrected visual acuity (BCVA) measured in logarithm of the minimum angle of resolution (logMAR) from baseline to 3 months after surgery. Outcomes will be compared between the phacovitrectomy and pars plana vitrectomy groups.
Measured: Baseline and 3 months after surgery
Secondary outcomes (1)
Need for Additional Surgical Intervention
Number of participants requiring additional vitreoretinal surgery or other ocular surgical intervention following the initial procedure.
Measured: Up to 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start15 Jan 2024
- Primary completion19 Jun 2026
- Study completion20 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndophthalmitisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible patients with post-intravitreal injection endophthalmitis were assigned to one of two parallel treatment groups. Group A underwent combined phacovitrectomy, and Group B underwent pars plana vitrectomy alone. Participants remained in their assigned treatment group throughout the study, and outcomes were compared between 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
- NCT07717944
- Sponsor's protocol ID
- PPIE-PHACO-2026
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Phacovitrectomy Versus Pars Plana Vitrectomy Alone in Patients With Post-Intravitreal Injection Endophthalmitis: A Retrospective Comparative Cohort Study
- ClinicalTrials.gov ID
- NCT07717944
- Acronym / sponsor ID
- PPIE-PHACO-2026
- Keywords
- Post-intravitreal injection endophthalmitis, Vitrectomy, Pars plana vitrectomy, Visual outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 19 Jun 2026 (actual)
- Study completion
- 20 Jun 2026 (actual)
- First posted
- 21 Jul 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.
This prospective comparative interventional study evaluated the anatomical and visual outcomes of phacovitrectomy versus pars plana vitrectomy (PPV) alone in patients with post-intravitreal injection endophthalmitis. Eligible patients underwent either combined phacovitrectomy or PPV alone according to the study protocol. The primary outcome was the change in best-corrected visual acuity (BCVA) from baseline to 3 months after surgery. Secondary outcomes included postoperative complications, need for additional surgical intervention, resolution of intraocular inflammation, and restoration of media clarity.
Detailed description
Post-intravitreal injection endophthalmitis is a rare but vision-threatening complication that requires prompt surgical intervention to maximize visual recovery. Pars plana vitrectomy (PPV) is the standard surgical treatment for severe cases; however, whether combining cataract extraction with vitrectomy provides superior anatomical and functional outcomes remains uncertain.
This prospective comparative interventional study was conducted to compare phacovitrectomy with PPV alone in the management of post-intravitreal injection endophthalmitis. Consecutive eligible phakic patients presenting with post-intravitreal injection endophthalmitis were enrolled between 2024 and June 2026 and underwent one of the two surgical approaches according to the study protocol.
Baseline demographic and clinical data were collected, including age, sex, indication for the original intravitreal injection, presenting best-corrected visual acuity (BCVA), clinical findings, microbiological results, and the interval between symptom onset and surgery. Operative details and postoperative follow-up data were prospectively recorded.
The primary outcome measure was the change in BCVA (logMAR) from baseline to 3 months after surgery. Secondary outcome measures included postoperative complications (such as retinal detachment, hypotony, persistent corneal edema, and recurrent infection), the need for additional surgical interventions, resolution of intraocular inflammation, restoration of media clarity, and anatomical success.
Comparative analyses were performed between the two treatment groups using appropriate statistical methods. Multivariable analyses were used to adjust for potential confounding factors, including baseline visual acuity, microbiological culture results, and time from presentation to surgery. The study aimed to determine whether combined phacovitrectomy provides superior visual and anatomical outcomes compared with PPV alone in patients with post-intravitreal injection endophthalmitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eligible patients with post-intravitreal injection endophthalmitis were assigned to one of two parallel treatment groups. Group A underwent combined phacovitrectomy, and Group B underwent pars plana vitrectomy alone. Participants remained in their assigned treatment group throughout the study, and outcomes were compared between groups.
| Arm | Type | Receives |
|---|---|---|
| Phacovitrectomy | Experimental | Procedure: PhacovitrectomyTwenty participants with post-intravitreal injection endophthalmitis underwent combined phacoemulsification with intraocular lens implantation and pars plana vitrectomy as the primary surgical treatment. Standard intravitreal antibiotics were administered according to the study protocol when indicated. |
| Pars Plana Vitrectomy Alone | Active comparator | Procedure: Pars plana vitrectomyTwenty participants with post-intravitreal injection endophthalmitis underwent pars plana vitrectomy alone as the primary surgical treatment. Standard intravitreal antibiotics were administered according to the study protocol when indicated. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Adults aged 18 years or older.
- Clinical diagnosis of acute post-intravitreal injection infectious endophthalmitis.
- History of intravitreal injection before the onset of endophthalmitis.
- Phakic eye at the time of presentation.
- Eyes with persistent or worsening clinical signs despite initial intravitreal antibiotic therapy (vancomycin and ceftazidime), requiring surgical intervention.
Key exclusion criteria (5 listed)
- Endophthalmitis secondary to causes other than intravitreal injection (e.g., post-cataract surgery, glaucoma surgery, penetrating ocular trauma, or endogenous endophthalmitis).
- Previous vitrectomy in the study eye.
- Pre-existing ocular conditions likely to significantly affect visual outcomes, including retinal detachment, advanced optic neuropathy, advanced glaucoma, or dense corneal opacity.
- Eyes with no visual potential before the onset of endophthalmitis.
- Inability to complete the scheduled follow-up visits or missing primary outcome data.
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 |
|---|---|---|
| PhacovitrectomyAlso: Combined phacoemulsification and pars plana vitrectomyCombined phacoemulsification with intraocular lens implantation and standard 23- or 25-gauge pars plana vitrectomy performed as the primary surgical treatment for post-intravitreal injection endophthalmitis. Vitrectomy included removal of vitreous opacities and inflammatory debris with intravitreal administration of antibiotics according to the study protocol. | Procedure or surgery | Phacovitrectomy |
| Pars plana vitrectomyAlso: PPVStandard 23- or 25-gauge pars plana vitrectomy performed as the primary surgical treatment for post-intravitreal injection endophthalmitis without simultaneous cataract extraction. Vitrectomy included removal of vitreous opacities and inflammatory debris with intravitreal administration of antibiotics according to the study protocol. | Procedure or surgery | Pars Plana Vitrectomy Alone |
Primary outcome
Change in Best-Corrected Visual Acuity (BCVA)
Time frame: Baseline and 3 months after surgery
Change in best-corrected visual acuity (BCVA) measured in logarithm of the minimum angle of resolution (logMAR) from baseline to 3 months after surgery. Outcomes will be compared between the phacovitrectomy and pars plana vitrectomy groups.
1 secondary outcome
Need for Additional Surgical Intervention
Time frame: Up to 3 months after surgery
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 21 Jul 2026.
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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 Phacovitrectomy and Pars plana vitrectomy in people with Endophthalmitis and Endophthalmitis Postoperative, 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 7 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: finished, as of the sponsor's last update on 21 Jul 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?
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?
Change in Best-Corrected Visual Acuity (BCVA) (time frame: Baseline and 3 months after surgery). 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 21 Jul 2026; AzTrials last refreshed its copy on 31 Oct 2026.