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.
Full Title of Study: “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”
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: April 2015
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.
- Procedure: Implantation of two iStent inject micro-bypass stents
- - Implantation of two trabecular micro-bypass stents (iStent inject) in a standalone procedure (i.e., without cataract surgery).
- Drug: Topical travoprost
- - Topical travoprost (0.004%, 1 drop each evening in study eye) started on postoperative Day 1.
- Device: Two iStent inject micro-bypass stents
- - Two trabecular micro-bypass stents (iStent inject) implanted in a standalone procedure.
- Drug: Tobramycin
- Topical antibiotic (tobramycin): 1 drop four (4) times per day in the study eye for one week (in cases of allergy or contraindication, Polytrim (polymyxin B sulfate + trimethoprim sulfate ophthalmic solution, USP, or equivalent) may be used as an alternative medication) .
- Drug: Dexamethasone
- Topical anti-inflammatory medication (dexamethasone ophthalmic suspension 0.1%): Week 1: 1 drop four (4) times per day in the study eye Week 2: 1 drop three (3) times per day in the study eye Week 3: 1 drop two (2) times per day in the study eye Week 4: 1 drop one (1) time per day in the study eye
Arms, Groups and Cohorts
- Other: 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
Clinical Trial Outcome Measures
- Mean intraocular pressure reduction of 20% or more versus baseline with reduction of 1 medication
- Time Frame: 12 months postoperative
- Mean intraocular pressure of 18 mmHg or less versus baseline with reduction of 1 medication
- Time Frame: 12 months postoperative
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Glaukos Corporation
- Provider of Information About this Clinical Study
- Overall Official(s)
- Lilit Voskanyan, MD, PhD, Principal Investigator, S.V. Malayan Eye Center
Berdahl J, Voskanyan L, Myers JS, Hornbeak DM, Giamporcaro JE, Katz LJ, Samuelson TW. Implantation of two second-generation trabecular micro-bypass stents and topical travoprost in open-angle glaucoma not controlled on two preoperative medications: 18-month follow-up. Clin Exp Ophthalmol. 2017 Nov;45(8):797-802. doi: 10.1111/ceo.12958. Epub 2017 Jun 2.
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