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
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
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Benha
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Banhā, Benha, Egitto, 13111
- Benha University
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Phacovitrectomy
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.
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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.
Altri nomi:
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Comparatore attivo: Pars Plana Vitrectomy Alone
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.
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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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Best-Corrected Visual Acuity (BCVA)
Lasso di tempo: Baseline and 3 months after surgery
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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.
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Baseline and 3 months after surgery
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Need for Additional Surgical Intervention
Lasso di tempo: Up to 3 months after surgery
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Number of participants requiring additional vitreoretinal surgery or other ocular surgical intervention following the initial procedure.
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Up to 3 months after surgery
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Collaboratori e investigatori
Sponsor
Collaboratori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- PPIE-PHACO-2026
Informazioni su farmaci e dispositivi, documenti di studio
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