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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
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.
University of California
San Francisco, California, United States
University of Florida
Gainesville, Florida, United States
Washington University
St Louis, Missouri, United States
Dean A. McGee Eye Institute
Oklahoma City, Oklahoma, United States
Postoperative Intraocular Pressure
Mean postoperative intraocular pressure
Time frame: assessed at 1d, 1w, 1m, 3m, 6m, 12m, 18m, 24m. 24 months reported
Medications
Time frame: assessed at 1d, 1w, 1m, 3m, 6m, 12m, 18m, 24m; 24 months reported
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.
Time frame: 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
Time frame: 24 months
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