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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
116
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.
Patients will undergo standard conventional trabeculectomy with intraoperative Mitomycin C application (concentration and duration as per standard practice at the study site
Ophthalmology department, Faculty of Medicine, Benha University
Banhā, Egypt
RECRUITING• Measure: Surgical success, defined as Intraocular Pressure (IOP) ≤ 15 mmHg and ≥ 20% reduction from baseline without glaucoma medications.
The proportion of eyes achieving the defined surgical success criteria
Time frame: 12 months post-surgery
• Measure: Mean Intraocular Pressure (IOP)
Average IOP measured at each follow-up visit.
Time frame: • Time Frame: 3, 6, and 12 months post-surgery
• Measure: Number of Glaucoma Medications
Average number of glaucoma medications required to maintain target IOP.
Time frame: 3, 6, and 12 months post-surgery
• Measure: Incidence of Surgical Complications
Rate and type of complications, including hypotony, bleb leakage, infection, tube exposure/migration, and choroidal detachment.
Time frame: From surgery to 12 months post-surgery
• Measure: Bleb Morphology and Function
Assessment using Ultrasound Biomicroscopy (UBM) and Anterior Segment Optical Coherence Tomography (AS-OCT).
Time frame: 6 and 12 months post-surgery
• Measure: Best Corrected Visual Acuity (BCVA)
Change in BCVA from baseline
Time frame: 3, 6, and 12 months post-surgery
• Measure: Visual Field Mean Deviation (MD)
Change in visual field mean deviation from baseline
Time frame: 6 and 12 months post-surgery
• Measure: Quality of Life (QoL)
Patient-reported outcomes using the NEI VFQ-25 questionnaire.
Time frame: 6 and 12 months post-surgery
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