Glaucoma Drainage Implants
Conditions
Interventions
This is a two-arm, blinded, randomized controlled clinical trial. Experimental group: 75 patients (75 eyes) will undergo implantation of the Ahmed ClearPath drainage device. Control group: 75 patients
Sponsors
Universidade Federal de São Paulo
Universidade Federal de São Paulo
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Best-corrected visual acuity of Light Perception (LP) or better, with good light projection. Diagnosis of refractory glaucoma by the attending physician: intraocular pressure not clinically controlled with maximum tolerated therapy, presence of previous fistulizing glaucoma surgery or cataract surgery, contraindication to fistulizing surgery. Indication for drainage tube implantation by the attending physician, with or without association with cataract surgery or vitrectomy. Age 18 years or older. Both sexes
Exclusion criteria
Exclusion criteria: Under 18 years of age. Previous drainage tube implantation procedure. Presence of retinal and/or choroidal detachment. Visual acuity with no light perception. Presence of ocular tumor. Patients unable to undergo the proposed examinations or to remain in the study for any reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A difference in mean intraocular pressure is expected, measured using a Goldmann applanation tonometer attached to a slit lamp or a portable rebound tonometer, with an observed mean difference of at least 2 mmHg between the groups | — |
Secondary
| Measure | Time frame |
|---|---|
| A similar complication rate is expected between the two groups;It is expected to find similar best-corrected visual acuity between the two groups;It is expected to find a similar rate of need for new antiglaucoma surgery between the two groups;It is expected to find a similar rate of need for drainage tube explantation between the two groups;It is expected to find a similar rate of surgical complications between the two groups;It is expected to find a lower number of antiglaucoma medications between the two groups, based on the finding of a mean difference in intraocular pressure of at least 2 mmHg between the groups | — |
Countries
Brazil
Contacts
Public ContactJoao Gomes
Universidade Federal de São Paulo
Outcome results
None listed