Two Trabecular Micro-bypass Stents & Postoperative Travoprost to Treat Glaucoma Subjects on Two Hypotensive Agents
- Conditions
- Open-angle Glaucoma
- Interventions
- Procedure: Implantation of two iStent inject micro-bypass stentsDevice: Two iStent inject micro-bypass stents
- Registration Number
- NCT02873806
- Lead Sponsor
- Glaukos Corporation
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
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
Baseline Exam Inclusion Criteria:
- Subject has completed appropriate medication washout
- Mean IOP > 22 mmHg and ≤ 38 mmHg after anti-glaucoma medication washout period
- A 3mmHg IOP increase over screening mean IOP
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.
- Any active corneal inflammation or edema (e.g., keratitis, keratoconjunctivitis, keratouveitis)
- Clinically significant corneal dystrophy (e.g., bullous keratopathy, Fuch's dystrophy); any guttata
- Corneal surgery (prior or anticipated) of any type (including LASIK, LASEK, PRK, etc.) that may interfere with IOP measurement reliability
- Corneal opacities that would inhibit visualization of the nasal angle
- Congenital or traumatic cataract
- Retinal or optic nerve disorders that are not associated with the existing glaucoma condition
- Elevated episcleral venous pressure such as associated with: active thyroid orbitopathy; cavernous sinus fistula; Sturge-Weber syndrome; orbital tumors; orbital congestive disease
- Clinically significant sequelae from trauma
- Chronic ocular inflammatory disease or presence of active ocular inflammation
Baseline Exam Exclusion Criteria:
- Subject did not complete medication washout
- Mean IOP < 22 mmHg or > 38 mmHg after anti-glaucoma medication washout
- Subject does not have a 3mmHg IOP increase over screening mean diurnal
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 2 micro-bypass stents & travoprost Implantation of two iStent inject micro-bypass stents Two iStent inject micro-bypass stents and topical travoprost Intervention: * Implantation of two iStent inject micro-bypass stents * Tobramycin * Dexamethasone 2 micro-bypass stents & travoprost Two iStent inject micro-bypass stents Two iStent inject micro-bypass stents and topical travoprost Intervention: * Implantation of two iStent inject micro-bypass stents * Tobramycin * Dexamethasone 2 micro-bypass stents & travoprost Topical travoprost Two iStent inject micro-bypass stents and topical travoprost Intervention: * Implantation of two iStent inject micro-bypass stents * Tobramycin * Dexamethasone 2 micro-bypass stents & travoprost Tobramycin Two iStent inject micro-bypass stents and topical travoprost Intervention: * Implantation of two iStent inject micro-bypass stents * Tobramycin * Dexamethasone 2 micro-bypass stents & travoprost Dexamethasone Two iStent inject micro-bypass stents and topical travoprost Intervention: * Implantation of two iStent inject micro-bypass stents * Tobramycin * Dexamethasone
- Primary Outcome Measures
Name Time Method Mean intraocular pressure reduction of 20% or more versus baseline with reduction of 1 medication 12 months postoperative
- Secondary Outcome Measures
Name Time Method Mean intraocular pressure of 18 mmHg or less versus baseline with reduction of 1 medication 12 months postoperative
Trial Locations
- Locations (1)
S.V. Malayan's Ophtalmology Centre
🇦🇲Yerevan, Armenia