Primary Tube Versus Trabeculectomy Study

Study Overview
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Brief Summary
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The purpose of the Primary Tube Versus Trabeculectomy (PTVT) Study is to compare the long-term safety and efficacy of nonvalved tube shunt surgery to trabeculectomy with mitomycin C in eyes that have not had previous ocular surgery.

Official Title
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Primary Tube Versus Trabeculectomy Study

Conditions
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Glaucoma

Intervention / Treatment
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* Procedure: Tube shunt surgery
* Procedure: Trabeculectomy
* Drug: Mitomycin C


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-85 years Glaucoma that is inadequately controlled on tolerated medical therapy with Intraocular Pressure (IOP) greater than or equal to 18 mm Hg and less than or equal to 40 mm Hg No previous incisional ocular surgery Exclusion Criteria: Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits Pregnant or nursing women No light perception vision Active iris neovascularization or active proliferative retinopathy Iridocorneal endothelial syndrome Epithelial or fibrous ingrowth Chronic or recurrent uveitis Steroid-induced glaucoma Severe posterior blepharitis Unwilling to discontinue contact lens use after surgery Previous cyclodestructive procedure Conjunctival scarring from prior ocular trauma or cicatrizing disease precluding a superior trabeculectomy Functionally significant cataract Need for glaucoma surgery combined with other ocular procedures or anticipated need for additional ocular surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tube shunt surgery group<br>Participants in this group will receive a tube shunt surgery (Baerveldt Glaucoma implant). | Procedure: Tube shunt surgery<br>* The procedure involves implantation of a Baerveldt consisting of a tube that is connected to an end plate. The tube is inserted into the anterior chamber and shunts aqueous humor to the end plate located in the equatorial region of the eye. The aqueous humor is then absorbed by the tissues around the eye.<br>* Other names: Baerveldt glaucoma implant;|
| Experimental: Trabeculectomy with Mitomycin C<br>Participants in this group will receive a Trabeculectomy surgery with Mitomycin C | Procedure: Trabeculectomy<br>* The procedure involves removal of a small portion of trabecular meshwork and adjacent tissue under a partial thickness scleral flap. Aqueous humor drains into the subconjunctival space producing a filtering bleb. The aqueous humor then diffuse out of the bleb.<br>Drug: Mitomycin C<br>* A fluid retaining sponge soaked in 0.4 mg/ml Mitomycin C will be applied in the region of Trabeculectomy site for about 2 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Surgical Failure | Surgical failure is defined as: Inadequate Intraocular Pressure (IOP) Reduction (IOP > 21 mmHg or reduced < 20% below baseline on 2 consecutive follow-up visits after 3 months) Reoperation for glaucoma Persistent hypotony (IOP ≤ 5 mmHg on 2 consecutive visits after 3 months) Loss of light perception vision | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure | Intraocular pressure will be reported in mmHg and measured using Goldmann applanation tonometry or a Tono-Pen. | At baseline, At 1 year, At 18 months, At 2 years, At 3 years, At 4 years, At 5 years | 
| Number of Participants With Reported Postoperative Complications | Number of participants with early and late postoperative complications will be reported as per treating physician assessment | Up to 5 years | 
| Visual Acuity Using a Snellen Chart | Visual acuity will be measured using a Snellen chart on logMAR (Logarithm of Minimal Angle of Resolution) scale. Letter-by letter results calculated the visual performance score for each chart read. logMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20. | At Baseline, At 5 years | 
| Visual Acuity as Measured Using EDTRS Chart | Visual acuity will be reported as the number of correctly identified letters on the Early Treatment Diabetic Retinopathy Study (EDTRS) chart. Total score ranges from 0-100 with the higher score indicating better visual acuity. | At baseline, At 5 years | 
| Visual Field | Visual fields will be measured using standard automated perimetry. | Up to 5 years | 
| Reoperation for Glaucoma | The number of participants requiring reoperation for glaucoma will be reported | Up to 5 years | 
| Number of Glaucoma Medications | The need for supplemental glaucoma medications will be reported as the number of glaucoma medications used | At Baseline, At 1 year, At 18 months, At 2 years, At 3 years, At 4 years, At 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tube shunt surgery, Trabeculectomy