Glaucoma, Innovative Procedures, Trabeculectomy
Conditions
Keywords
glaucoma, innovative, tube trabeculectomy
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREInnovative 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.
PROCEDUREConventional Trabeculectomy
Patients will undergo standard conventional trabeculectomy with intraoperative Mitomycin C application (concentration and duration as per standard practice at the study site
Sponsors
Benha University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Blinding of participants and care providers is not feasible due to the nature of surgical interventions and distinct postoperative care protocols
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| • Measure: Surgical success, defined as Intraocular Pressure (IOP) ≤ 15 mmHg and ≥ 20% reduction from baseline without glaucoma medications. | 12 months post-surgery | The proportion of eyes achieving the defined surgical success criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| • Measure: Mean Intraocular Pressure (IOP) | • Time Frame: 3, 6, and 12 months post-surgery | Average IOP measured at each follow-up visit. |
| • Measure: Number of Glaucoma Medications | 3, 6, and 12 months post-surgery | Average number of glaucoma medications required to maintain target IOP. |
| • Measure: Incidence of Surgical Complications | From surgery to 12 months post-surgery | Rate and type of complications, including hypotony, bleb leakage, infection, tube exposure/migration, and choroidal detachment. |
| • Measure: Bleb Morphology and Function | 6 and 12 months post-surgery | Assessment using Ultrasound Biomicroscopy (UBM) and Anterior Segment Optical Coherence Tomography (AS-OCT). |
| • Measure: Best Corrected Visual Acuity (BCVA) | 3, 6, and 12 months post-surgery | Change in BCVA from baseline |
| • Measure: Visual Field Mean Deviation (MD) | 6 and 12 months post-surgery | Change in visual field mean deviation from baseline |
| • Measure: Quality of Life (QoL) | 6 and 12 months post-surgery | Patient-reported outcomes using the NEI VFQ-25 questionnaire. |
Countries
Egypt
Contacts
CONTACTAhmed M Saeed, MD
STUDY_DIRECTORTarek Abulnasr, MD
Benha University
Outcome results
None listed