Innovative Tube Trabeculectomy for Advanced and Refractory Glaucoma: A Randomized Controlled Trial (ITT-RCT)
5 augustus 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Werving
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Geschat)
116
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Ahmed M Saeed, MD
- Telefoonnummer: 01227468426
- E-mail: ahmed.abdelhamid@fmed.bu.edu.eg
Studie Locaties
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Banhā, Egypte, 13518
- Werving
- Ophthalmology department, Faculty of Medicine, Benha University
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Contact:
- Mohamed G AlAshhab, MD
- Telefoonnummer: 0133227518
- E-mail: info@fmed.bu.edu.eg
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Onderonderzoeker:
- Tarek Abulnasr, MD
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Hoofdonderzoeker:
- Ahmed M Saeed, MD
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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.
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Actieve vergelijker: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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• Measure: Surgical success, defined as Intraocular Pressure (IOP) ≤ 15 mmHg and ≥ 20% reduction from baseline without glaucoma medications.
Tijdsspanne: 12 months post-surgery
|
The proportion of eyes achieving the defined surgical success criteria
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12 months post-surgery
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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• Measure: Mean Intraocular Pressure (IOP)
Tijdsspanne: • 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: Tarek Abulnasr, MD, Benha University
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 augustus 2026
Primaire voltooiing (Geschat)
1 augustus 2027
Studie voltooiing (Geschat)
1 augustus 2028
Studieregistratiedata
Eerst ingediend
5 augustus 2026
Eerst ingediend dat voldeed aan de QC-criteria
5 augustus 2026
Eerst geplaatst (Werkelijk)
10 augustus 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
10 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
5 augustus 2026
Laatst geverifieerd
1 augustus 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Innovative Tube Trabeculectomy
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
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.
IPD-tijdsbestek voor delen
Data will be available beginning 6 months and ending 36 months following the official publication of the study results.
IPD-toegangscriteria voor delen
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.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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