At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi Center Study Comparing the Ex-PRESSTM Mini Glaucoma Shunt to Trabeculectomy in Subjects With Open Angle Glaucoma
In Brief
A clinical study evaluating Trabeculectomy and Ex-PRESS mini shunt for Glaucoma. Completed, enrolled 120 participants across 8 sites in 2 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
Standard trabeculectomy procedure 1. Creation of a fornix or limbal based conjunctival flap in upper quadrants 2. Creation of a limbal-based scleral flap extending into clear cornea 3. Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes) 4. Creation of fistula 1mm x 2mm in size 5. Iridectomy 6. Suturing the scleral flap 7. Repositioning of conjunctiva with sutures After procedure, antibiotics \& steroids are administered topically; eye is covered with a pad - patient is discharged.
Ex-PRESS implantation procedure: 1. Creation of a fornix or limbal based conjunctival flap in upper quadrants 2. Creation of limbal-based scleral flap extending into clear cornea 3. Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes) 4. 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 5. Prior to implantation, a thorough mobility check should be performed 6. Implantation of Ex-PRESS implant loaded on its introducer, through that pre-incision 7. Withdrawal of introducer 8. Tucking plate under the scleral flap, and verification of its position 9. Suturing scleral flap After implantation procedure, antibiotics \& steroids administered topically; eye is covered with a pad - patient is discharged.