NCT02868190已完成4 期
A Prospective Evaluation of Open-angle Glaucoma Subjects on One Topical Hypotensive Medication (Prostaglandin) Treated With Two Trabecular Micro-bypass Stents (iStent Inject)
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Mean intraocular pressure reduction of 20% or more vs baseline
研究概览
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Screening Exam Inclusion Criteria:
- •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:
- •Subject has completed appropriate medication washout.
- •Mean IOP > 22 mmHg and ≤ 38 mmHg after anti-glaucoma medication washout period.
排除标准
- •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 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).
- •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 or disorders that would inhibit visualization of the nasal angle.
- •Congenital or traumatic cataract.
- •Retinal or optic nerve disorders, either degenerative or evolutive, 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 (e.g., chemical burns, blunt trauma, etc.).
- •Chronic ocular inflammatory disease or presence of active ocular inflammation (e.g., uveitis, iritis, iridocyclitis, retinitis).
- •Pregnant or nursing women.
- •Baseline Exam Exclusion Criteria:
- •Subject did not complete medication washout.
- •Mean IOP < 22 mmHg or > 38 mmHg after anti-glaucoma medication washout.
- •Subject did not have a 3mmHg IOP increase over screening mean diurnal IOP.
研究组 & 干预措施
Two micro-bypass stents (iStent inject)
Other
Standalone implantation of two trabecular micro-bypass stents (iStent inject)
干预措施: Two trabecular micro-bypass stents (iStent inject) (Device)
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)
研究者
研究点 (1)
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