A Study of the Trabecular Micro-bypass Stent in Combination With Cataract Surgery in Subjects With Open Angle Glaucoma
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The purpose of this study is to evaluate the safety and efficacy of the iStent trabecular micro-bypass stent in reducing intraocular pressure (IOP) in subjects with open-angle glaucoma or ocular hypertension and co-existing cataract.
Full description
The purpose of this study is to evaluate the safety and efficacy of the iStent trabecular micro-bypass stent in reducing intraocular pressure (IOP) in subjects with open-angle glaucoma or ocular hypertension and co-existing cataract. Pre-operative unmedicated baseline pressures will be compared with post operative values in both study arms.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Diagnosed with open-angle glaucoma (OAG) in the study eye. Pseudoexfoliative and pigmentary glaucoma are also acceptable diagnoses.
- Subject on at least one glaucoma medication
- Able and willing to attend follow up visits for two years post operative
- Able and willing to sign informed consent
Exclusion criteria
- Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt implant, collagen implant, cyclo destructive procedures etc)
- Angle closure glaucoma
- Fellow eye already enrolled
Trial design
Primary purpose
Allocation
Interventional model
Masking
240 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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