Comparing Hydrus Microstent(TM) to the iStent for Lowering IOP in Glaucoma Patients Undergoing Cataract Surgery
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Ocular, Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 4/17/2018 |
| Start Date: | August 2011 |
| End Date: | July 2018 |
A Prospective, Multicenter, Randomized Comparison of the Hydrus Microstent to the iStent for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery
This clinical trial compares two implantable devices intended to lower the pressure inside
the eye of glaucoma patients. One of the two devices will be implanted immediately following
cataract surgery and the placement of a posterior chamber intra-ocular lens.
the eye of glaucoma patients. One of the two devices will be implanted immediately following
cataract surgery and the placement of a posterior chamber intra-ocular lens.
This is a prospective, multicenter, single-masked, randomized clinical trial comparing
Cataract Extraction (CE) + Hydrus Microstent to CE surgery + iStent implant for the reduction
of intraocular pressure in patients with a positive diagnosis of primary open angle glaucoma,
pseudoexfoliative glaucoma, or pigmentary dispersion glaucoma with an operable cataract.
Eligible patients will be scheduled for cataract surgery. At the conclusion of successful
cataract surgery and the placement of a posterior-chamber IOL, qualified subjects will be
randomized to receive either the Hydrus Microstent or the iStent implant. Post-operative
follow-up visits will be conducted at regular intervals.
Cataract Extraction (CE) + Hydrus Microstent to CE surgery + iStent implant for the reduction
of intraocular pressure in patients with a positive diagnosis of primary open angle glaucoma,
pseudoexfoliative glaucoma, or pigmentary dispersion glaucoma with an operable cataract.
Eligible patients will be scheduled for cataract surgery. At the conclusion of successful
cataract surgery and the placement of a posterior-chamber IOL, qualified subjects will be
randomized to receive either the Hydrus Microstent or the iStent implant. Post-operative
follow-up visits will be conducted at regular intervals.
Inclusion Criteria:
- A diagnosis of primary open angle glaucoma (POAG), Pseudoexfoliative (PXG) glaucoma,
or Pigmentary dispersion glaucoma (PDG)
- An operable age-related cataract with BCVA of 20/40 or worse, eligible for
phacoemulsification.
Exclusion Criteria:
- Forms of primary or secondary glaucoma not listed above
- Prior glaucoma surgery in the study eye
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