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Innovative Tube Trabeculectomy for Advanced and Refractory Glaucoma: A Randomized Controlled Trial (ITT-RCT)

5. august 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

116

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Egypten
      • Banhā, Egypten, 13518
        • Rekruttering
        • Ophthalmology department, Faculty of Medicine, Benha University
        • Kontakt:
        • Underforsker:
          • Tarek Abulnasr, MD
        • Ledende efterforsker:
          • Ahmed M Saeed, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Procedure: Innovative Tube Trabeculectomy
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.
Aktiv komparator: 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).
Procedure: Conventional Trabeculectomy
Patients will undergo standard conventional trabeculectomy with intraoperative Mitomycin C application (concentration and duration as per standard practice at the study site

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
• Measure: Surgical success, defined as Intraocular Pressure (IOP) ≤ 15 mmHg and ≥ 20% reduction from baseline without glaucoma medications.
Tidsramme: 12 months post-surgery
The proportion of eyes achieving the defined surgical success criteria
12 months post-surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
• Measure: Mean Intraocular Pressure (IOP)
Tidsramme: • Time Frame: 3, 6, and 12 months post-surgery
Average IOP measured at each follow-up visit.
• Time Frame: 3, 6, and 12 months post-surgery
• Measure: Number of Glaucoma Medications
Tidsramme: 3, 6, and 12 months post-surgery
Average number of glaucoma medications required to maintain target IOP.
3, 6, and 12 months post-surgery
• Measure: Incidence of Surgical Complications
Tidsramme: From surgery to 12 months post-surgery
Rate and type of complications, including hypotony, bleb leakage, infection, tube exposure/migration, and choroidal detachment.
From surgery to 12 months post-surgery
• Measure: Bleb Morphology and Function
Tidsramme: 6 and 12 months post-surgery
Assessment using Ultrasound Biomicroscopy (UBM) and Anterior Segment Optical Coherence Tomography (AS-OCT).
6 and 12 months post-surgery
• Measure: Best Corrected Visual Acuity (BCVA)
Tidsramme: 3, 6, and 12 months post-surgery
Change in BCVA from baseline
3, 6, and 12 months post-surgery
• Measure: Visual Field Mean Deviation (MD)
Tidsramme: 6 and 12 months post-surgery
Change in visual field mean deviation from baseline
6 and 12 months post-surgery
• Measure: Quality of Life (QoL)
Tidsramme: 6 and 12 months post-surgery
Patient-reported outcomes using the NEI VFQ-25 questionnaire.
6 and 12 months post-surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Benha University

Efterforskere

  • Studieleder: Tarek Abulnasr, MD, Benha University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. august 2026

Primær færdiggørelse (Anslået)

1. august 2027

Studieafslutning (Anslået)

1. august 2028

Datoer for studieregistrering

Først indsendt

5. august 2026

Først indsendt, der opfyldte QC-kriterier

5. august 2026

Først opslået (Faktiske)

10. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Innovative Tube Trabeculectomy

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

Data will be available beginning 6 months and ending 36 months following the official publication of the study results.

IPD-delingsadgangskriterier

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-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

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