A Prospective Evaluation of Open-angle Glaucoma Subjects on One Topical Hypotensive Medication (Prostaglandin) Treated With Two Trabecular Micro-bypass Stents (iStent Inject)
概览
- 阶段
- 4 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Open Angle Glaucoma
- 发起方
- Glaukos Corporation
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Mean intraocular pressure reduction of 20% or more vs baseline
- 状态
- 已完成
- 最后更新
- 3年前
概览
简要总结
This study objective is to evaluate the intraocular pressure (IOP) lowering effect of two trabecular micro-bypass stents (iStent inject) in eyes of subjects with primary open-angle glaucoma on one topical hypotensive medication
详细描述
The study design is as follows: Prospective Subjects with medicated IOP \> 18 mmHg and ≤ 30 mmHg Subjects on one topical ocular hypotensive medication prior to stent implantation Implantation of two iStent 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 Diurnal IOP measurements Follow-up through 60 months postoperative (but could be 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
研究者
入排标准
入选标准
- •Phakic patients or pseudophakic patients with posterior chamber intraocular lenses (PC-IOLs).
- •Primary open-angle glaucoma (including pigmentary or pseudoexfoliative).
- •Cup-to-disc ratio ≤ 0.
- •Visual field defects, or nerve abnormality characteristic of glaucoma.
- •One topical hypotensive medication at time of screening exam.
- •Intraocular pressure (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:
排除标准
- •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 such as Bjerrum scotoma.
- •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 such as: visual field status would be placed at risk by washout period, or unmedicated IOP after washout period would be expected to exceed upper limit of ≥ 38 mmHg.
- •Any active corneal inflammation or edema (e.g., keratitis, keratoconjunctivitis, keratouveitis).
结局指标
主要结局
Mean intraocular pressure reduction of 20% or more vs baseline
时间窗: 12 months post-op
次要结局
- Proportion of subjects with intraocular pressure less than or equal to 18 mm Hg(12 months)