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Phacovitrectomy Versus Pars Plana Vitrectomy Alone for Post-Intravitreal Injection Endophthalmitis

Outcomes of Phacovitrectomy Versus Pars Plana Vitrectomy Alone in Patients With Post-Intravitreal Injection Endophthalmitis: A Retrospective Comparative Cohort Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07717944
Enrollment
40
Registered
2026-07-21
Start date
2024-01-15
Completion date
2026-06-20
Last updated
2026-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endophthalmitis, Endophthalmitis Postoperative, Intravitreal Injection Patients

Keywords

Post-intravitreal injection endophthalmitis, Vitrectomy, Pars plana vitrectomy, Visual outcomes

Brief 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. 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.

Interventions

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.

PROCEDUREPars plana vitrectomy

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.

Sponsors

Benha University
Lead SponsorOTHER
faculty of medicine, Benha university
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Best-Corrected Visual Acuity (BCVA)Baseline and 3 months after surgeryChange 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.

Secondary

MeasureTime frameDescription
Need for Additional Surgical InterventionUp to 3 months after surgeryNumber of participants requiring additional vitreoretinal surgery or other ocular surgical intervention following the initial procedure.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 22, 2026