- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07717944
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
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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 de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Benha
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Banhā, Benha, Egipto, 13111
- Benha University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
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.
Otros nombres:
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Comparador activo: 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.
|
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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Best-Corrected Visual Acuity (BCVA)
Periodo de tiempo: 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.
|
Baseline and 3 months after surgery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Need for Additional Surgical Intervention
Periodo de tiempo: Up to 3 months after surgery
|
Number of participants requiring additional vitreoretinal surgery or other ocular surgical intervention following the initial procedure.
|
Up to 3 months after surgery
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PPIE-PHACO-2026
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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