Comparison of Ex-PRESSTM Mini Glaucoma Shunt to Trabeculectomy in Subjects With Open Angle Glaucoma

Study Overview
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Brief Summary
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A prospective randomized trial to compare the safety and efficacy of the Ex-PRESS to trabeculectomy in patients with open angle glaucoma who failed medical or are allergic to medical treatment and for which filtering surgery is indicated. Surgical success was defined as 5 mmHg ≤ intraocular pressure ≤ 18 mmHg, with or without medications, without further glaucoma surgery. Postoperative intraocular pressure, number of medications, complications and success rates were followed for 2 years.

Official Title
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A Multi Center Study Comparing the Ex-PRESSTM Mini Glaucoma Shunt to Trabeculectomy in Subjects With Open Angle Glaucoma

Conditions
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Glaucoma

Intervention / Treatment
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* Procedure: Trabeculectomy
* Device: Ex-PRESS mini shunt


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult subject over the age of 18 Subject diagnosed with open angle glaucoma (POAG, PXFG or PDSG) or ocular hypertension Subject is a candidate for filtering surgery with intraoperative anti-metabolites IOP > 18 mmHg on maximum tolerated medial therapy based on two measurements taken 1 hour apart at the same visit. Subject willing to attend all follow-up evaluations Subject willing to sign informed consent. Exclusion Criteria: Subject diagnosed with: PACG, NTG, secondary glaucoma, neovascular glaucoma Subject has history of glaucoma surgery (filtering, glaucoma drainage device, cyclo destructive procedures) Subject has history of penetrating keratoplasty (PKP) Subject underwent large incision extra capsular cataract extraction Subject had cataract phacoemulsification within the last month Subject has a visually significant cataract that is planned for extraction at the time of filtering surgery or within 12 months thereafter Any ocular disease or history in the operated eye other than glaucoma and cataract, such as uveitis, ocular infection, severe dry eye, severe blepharitis , active proliferative retinopathy, ICE syndrome, epithelial or fibrous down growth, aphakia, and ocular pathology that may interfere with accurate IOP measurements Subject has vitreous present in the anterior chamber for which vitrectomy is anticipated IOP of ≤18mmHg Subject participates in any other concurrent ocular investigation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| Active Comparator: Control Arm<br>Subjects undergoing trabeculectomy with the use of Mitomycin C | Procedure: Trabeculectomy<br>* Standard trabeculectomy procedure Creation of a fornix or limbal based conjunctival flap in upper quadrants Creation of a limbal-based scleral flap extending into clear cornea Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes) Creation of fistula 1mm x 2mm in size Iridectomy Suturing the scleral flap Repositioning of conjunctiva with sutures After procedure, antibiotics & steroids are administered topically; eye is covered with a pad - patient is discharged.<br>|
| Experimental: Treatment Arm<br>Subjects undergoing Ex-PRESS Under Scleral Flap implantation procedure with the use of Mitomycin C | Device: Ex-PRESS mini shunt<br>* Ex-PRESS implantation procedure: Creation of a fornix or limbal based conjunctival flap in upper quadrants Creation of limbal-based scleral flap extending into clear cornea Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes) Penetration into anterior chamber using 23-25G needle, halfway between the white sclera and clear cornea (in the center of the grey zone);creation of track incision at limbus Prior to implantation, a thorough mobility check should be performed Implantation of Ex-PRESS implant loaded on its introducer, through that pre-incision Withdrawal of introducer Tucking plate under the scleral flap, and verification of its position Suturing scleral flap After implantation procedure, antibiotics & steroids administered topically; eye is covered with a pad - patient is discharged.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Intraocular Pressure | Mean postoperative intraocular pressure | assessed at 1d, 1w, 1m, 3m, 6m, 12m, 18m, 24m. 24 months reported | 
| Medications |  | assessed at 1d, 1w, 1m, 3m, 6m, 12m, 18m, 24m; 24 months reported | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - Incidence of Adverse Events | Comparison of the incidence of all adverse events that occur during the intra-operative and postoperative periods between the two study arms. More than 1 complication may have occurred in the same subject. | 24 months | 
| Efficacy - The Number of Participants With Qualified and Complete Success | The secondary effectiveness measure will be qualified and complete success rate defined as IOP≤18mmHg with or without medications in the test group as compared to qualified and complete success rate in the concurrent control group at 24 month | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ex-PRESS, TRABECULECTOMY