A Prospective Evaluation of Open-angle Glaucoma Subjects on Two Topical Hypotensive Medications (One a Prostaglandin) Treated With Two Trabecular Micro-bypass Stents (iStent Inject) and a Postoperative Topical Prostaglandin
Overview
- Phase
- Phase 4
- Intervention
- Implantation of two iStent inject micro-bypass stents
- Conditions
- Open-angle Glaucoma
- Sponsor
- Glaukos Corporation
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- Mean intraocular pressure reduction of 20% or more versus baseline with reduction of 1 medication
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The study objective was to evaluate the intraocular pressure (IOP) lowering effect of two iStent devices in eyes of subjects with primary open-angle glaucoma, washed out of two anti-glaucoma medications (one a Prostaglandin) prior to stent implantation.
Detailed Description
The study design is as follows: * Prospective, single-arm study. * Subjects with open-angle glaucoma and medicated IOP \> 18 mmHg and ≤ 30 mmHg. * Subjects on two topical ocular hypotensive medications (one a prostaglandin). * Implantation of two iStent inject devices (if IOP is \< 6 mmHg, at any point during the postoperative follow-up, medication will not be prescribed or will be discontinued). * IOP will be measured by two (2) observers to minimize bias; observer 1 will look through the slit lamp and turn the dial with readings being masked, and observer 2 will document the IOP. * Follow-up through 60 months postoperative (or up to 61 months if subject needs to undergo terminal washout). * Descriptive statistics will be tabulated. * Medical therapy considered necessary for the subject's welfare can be implemented at any time during the study at the investigator's discretion.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Screening Exam Inclusion Criteria:
- •Phakic patients or pseudophakic patients with posterior chamber intraocular lenses (PC-IOLs)
- •Primary open-angle glaucoma (including pigmentary or pseudoexfoliative)
- •C/D ratio ≤ 0.9
- •Visual field defects, or nerve abnormality characteristic of glaucoma
- •Two topical hypotensive medications at time of screening exam
- •IOP \> 18 mmHg and ≤ 30 mmHg (medicated) at screening exam
- •Study eye BCVA 20/100 or better
- •Normal angle anatomy as determined by gonioscopy
- •Absence of peripheral anterior synechia (PAS), rubeosis or other angle abnormalities that could impair proper placement of stent
Exclusion Criteria
- •Screening Exam Exclusion Criteria:
- •Aphakic patients or pseudophakic patients with anterior chamber IOLs (AC-IOLs)
- •Prior stent implantations (study eye)
- •Traumatic, uveitic, neovascular, or angle-closure glaucoma; or glaucoma associated with vascular disorders
- •Functionally significant visual field loss, including severe nerve fiber bundle defects
- •Prior incisional glaucoma surgery
- •Prior SLT within 90 days prior to screening
- •Prior ALT
- •Iridectomy or laser iridotomy
- •Ineligibility for ocular hypotensive medication washout period as determined by the investigator.
Arms & Interventions
2 micro-bypass stents & travoprost
Two iStent inject micro-bypass stents and topical travoprost Intervention: * Implantation of two iStent inject micro-bypass stents * Tobramycin * Dexamethasone
Intervention: Implantation of two iStent inject micro-bypass stents
2 micro-bypass stents & travoprost
Two iStent inject micro-bypass stents and topical travoprost Intervention: * Implantation of two iStent inject micro-bypass stents * Tobramycin * Dexamethasone
Intervention: Topical travoprost
2 micro-bypass stents & travoprost
Two iStent inject micro-bypass stents and topical travoprost Intervention: * Implantation of two iStent inject micro-bypass stents * Tobramycin * Dexamethasone
Intervention: Two iStent inject micro-bypass stents
2 micro-bypass stents & travoprost
Two iStent inject micro-bypass stents and topical travoprost Intervention: * Implantation of two iStent inject micro-bypass stents * Tobramycin * Dexamethasone
Intervention: Tobramycin
2 micro-bypass stents & travoprost
Two iStent inject micro-bypass stents and topical travoprost Intervention: * Implantation of two iStent inject micro-bypass stents * Tobramycin * Dexamethasone
Intervention: Dexamethasone
Outcomes
Primary Outcomes
Mean intraocular pressure reduction of 20% or more versus baseline with reduction of 1 medication
Time Frame: 12 months postoperative
Secondary Outcomes
- Mean intraocular pressure of 18 mmHg or less versus baseline with reduction of 1 medication(12 months postoperative)