Innovative Tube Trabeculectomy for Advanced and Refractory Glaucoma: A Randomized Controlled Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBenha University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Innovative Tube Trabeculectomy
Procedure/SurgeryPatients 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.
Conventional Trabeculectomy
Procedure/SurgeryPatients will undergo standard conventional trabeculectomy with intraoperative Mitomycin C application (concentration and duration as per standard practice at the study site
Treatment groups
116 Participants
are divided into 2 treatment groupsGroup A: Arm 1: Innovative Tube Trabeculectomy (ITT)Experimental treatment 1 intervention
Group B: Arm 2: Conventional TrabeculectomyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
• 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-surgerySecondary outcomes
1
• Measure: Mean Intraocular Pressure (IOP)
Average IOP measured at each follow-up visit.
Time frame
• Time Frame: 3, 6, and 12 months post-surgery2
• Measure: Number of Glaucoma Medications
Average number of glaucoma medications required to maintain target IOP.
Time frame
3, 6, and 12 months post-surgery3
• 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-surgery4
• 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-surgerySponsors and contacts
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Source ClinicalTrials.gov