Innovative Tube Trabeculectomy for Advanced and Refractory Glaucoma: A Randomized Controlled Trial (ITT-RCT)
5 de agosto de 2026 actualizado por: Ahmed Mohamed Saeed Abdel Hamid, Benha University
A Prospective, Randomized, Controlled, Single-Center Clinical Trial to Evaluate the Efficacy and Safety of Innovative Tube Trabeculectomy Compared to Conventional Trabeculectomy in Patients With Advanced and Refractory Glaucoma
This study aims to compare the efficacy and safety of a novel surgical technique, Innovative Tube Trabeculectomy (ITT), against conventional trabeculectomy in patients with advanced and refractory glaucoma.
ITT incorporates a unique preoperative regimen and surgical modifications, including a deep extended scleral tunnel, X-shaped non-absorbable suture, and a nasolacrimal tube implant, designed to enhance aqueous humor outflow and reduce postoperative fibrosis.
Participants will be randomized to receive either ITT or conventional trabeculectomy and followed for 12 months to assess intraocular pressure control, medication use, complication rates, and bleb morphology.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
Glaucoma is a leading cause of irreversible blindness.
While trabeculectomy is a standard surgical intervention, its long-term success can be compromised by fibrosis.
The ITT technique introduces several innovations to address these limitations.
This single-center, prospective, randomized controlled trial will enroll adult patients with advanced or refractory open-angle glaucoma.
Patients will undergo a rigorous preoperative regimen before being randomized to either the ITT group or the conventional trabeculectomy group.
The primary outcome will be surgical success (IOP ≤ 15 mmHg and ≥ 20% reduction from baseline without medication) at 12 months.
Secondary outcomes include mean IOP, medication burden, complication rates, bleb morphology (UBM/AS-OCT), visual acuity, visual fields, and quality of life.
The study will provide crucial evidence on the potential benefits of ITT for this challenging patient population.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
116
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Ahmed M Saeed, MD
- Número de teléfono: 01227468426
- Correo electrónico: ahmed.abdelhamid@fmed.bu.edu.eg
Ubicaciones de estudio
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Banhā, Egipto, 13518
- Reclutamiento
- Ophthalmology department, Faculty of Medicine, Benha University
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Contacto:
- Mohamed G AlAshhab, MD
- Número de teléfono: 0133227518
- Correo electrónico: info@fmed.bu.edu.eg
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Sub-Investigador:
- Tarek Abulnasr, MD
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Investigador principal:
- Ahmed M Saeed, MD
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- • Diagnosis of advanced or refractory primary open-angle glaucoma (POAG) or secondary open-angle glaucoma (excluding neovascular glaucoma).
- Intraocular pressure (IOP) > 21 mmHg despite maximal tolerated medical therapy or previous failed glaucoma surgery.
- Best corrected visual acuity (BCVA) of 20/400 or better.
- Capable of providing informed consent
Exclusion Criteria:
- Previous incisional glaucoma surgery in the study eye (except for prior failed trabeculectomy in the refractory group).
- Neovascular glaucoma or other forms of secondary glaucoma that may significantly impact wound healing (e.g., uveitic glaucoma).
- Significant ocular comorbidities that may confound outcome assessment (e.g., severe corneal disease, retinal detachment).
- Pregnancy or lactation.
- Participation in another clinical trial within 30 days prior to enrollment.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Arm 1: Innovative Tube Trabeculectomy (ITT)
Patients will undergo the innovative tube trabeculectomy procedure.
This includes a 3-week preoperative regimen (discontinuation of preserved medications and prostaglandin analogs, initiation of fluorometholone), a 1-week preoperative subconjunctival injection (Mitomycin C 0.04%, Avastin 1.25 mg, Dexamethasone 8 mg), and the surgical technique involving a deep extended scleral tunnel, intraoperative Mitomycin C application, X-shaped non-absorbable suture, and nasolacrimal tube implantation.
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Patients will undergo the innovative tube trabeculectomy procedure.
This includes a 3-week preoperative regimen (discontinuation of preserved medications and prostaglandin analogs, initiation of fluorometholone), a 1-week preoperative subconjunctival injection (Mitomycin C 0.04%, Avastin 1.25 mg, Dexamethasone 8 mg), and the surgical technique involving a deep extended scleral tunnel, intraoperative Mitomycin C application, X-shaped non-absorbable suture, and nasolacrimal tube implantation.
|
|
Comparador activo: Arm 2: Conventional Trabeculectomy
Patients will undergo standard conventional trabeculectomy with intraoperative Mitomycin C application (concentration and duration as per standard practice at the study site).
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Patients will undergo standard conventional trabeculectomy with intraoperative Mitomycin C application (concentration and duration as per standard practice at the study site
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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• Measure: Surgical success, defined as Intraocular Pressure (IOP) ≤ 15 mmHg and ≥ 20% reduction from baseline without glaucoma medications.
Periodo de tiempo: 12 months post-surgery
|
The proportion of eyes achieving the defined surgical success criteria
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12 months post-surgery
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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• Measure: Mean Intraocular Pressure (IOP)
Periodo de tiempo: • Time Frame: 3, 6, and 12 months post-surgery
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Average IOP measured at each follow-up visit.
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• Time Frame: 3, 6, and 12 months post-surgery
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• Measure: Number of Glaucoma Medications
Periodo de tiempo: 3, 6, and 12 months post-surgery
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Average number of glaucoma medications required to maintain target IOP.
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3, 6, and 12 months post-surgery
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• Measure: Incidence of Surgical Complications
Periodo de tiempo: From surgery to 12 months post-surgery
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Rate and type of complications, including hypotony, bleb leakage, infection, tube exposure/migration, and choroidal detachment.
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From surgery to 12 months post-surgery
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• Measure: Bleb Morphology and Function
Periodo de tiempo: 6 and 12 months post-surgery
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Assessment using Ultrasound Biomicroscopy (UBM) and Anterior Segment Optical Coherence Tomography (AS-OCT).
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6 and 12 months post-surgery
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• Measure: Best Corrected Visual Acuity (BCVA)
Periodo de tiempo: 3, 6, and 12 months post-surgery
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Change in BCVA from baseline
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3, 6, and 12 months post-surgery
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• Measure: Visual Field Mean Deviation (MD)
Periodo de tiempo: 6 and 12 months post-surgery
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Change in visual field mean deviation from baseline
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6 and 12 months post-surgery
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• Measure: Quality of Life (QoL)
Periodo de tiempo: 6 and 12 months post-surgery
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Patient-reported outcomes using the NEI VFQ-25 questionnaire.
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6 and 12 months post-surgery
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Tarek Abulnasr, MD, Benha University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de agosto de 2026
Finalización primaria (Estimado)
1 de agosto de 2027
Finalización del estudio (Estimado)
1 de agosto de 2028
Fechas de registro del estudio
Enviado por primera vez
5 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
5 de agosto de 2026
Publicado por primera vez (Actual)
10 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
5 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Innovative Tube Trabeculectomy
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
What IPD will be shared? De-identified individual participant data that underlie the results reported in the final study, including demographic characteristics and ocular surface/meibomian gland assessment parameters.
Supporting Documents: The study protocol and statistical analysis plan will be made available.
When will data be available? Data will be available beginning 6 months and ending 36 months following the official publication of the study results.
With whom? Data will be shared with qualified researchers who provide a methodologically sound proposal that is approved by the study investigators.
For what types of analyses? To achieve the specific aims outlined in the approved research proposal.
By what mechanism will data be made available? Interested researchers should contact the corresponding author via email to submit a formal request and a data use agreement.
Marco de tiempo para compartir IPD
Data will be available beginning 6 months and ending 36 months following the official publication of the study results.
Criterios de acceso compartido de IPD
Data will be shared with qualified researchers who provide a methodologically sound proposal that is approved by the study investigators.
Interested researchers should contact the corresponding author via email to submit a formal request and a data use agreement.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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