NCT02873806已完成4 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Mean intraocular pressure reduction of 20% or more versus baseline with reduction of 1 medication
研究概览
简要总结
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.
详细描述
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.
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)
- •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
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
- •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
研究组 & 干预措施
2 micro-bypass stents & travoprost
Other
Two iStent inject micro-bypass stents and topical travoprost
Intervention:
- Implantation of two iStent inject micro-bypass stents
- Tobramycin
- Dexamethasone
干预措施: Implantation of two iStent inject micro-bypass stents (Procedure)
2 micro-bypass stents & travoprost
Other
Two iStent inject micro-bypass stents and topical travoprost
Intervention:
- Implantation of two iStent inject micro-bypass stents
- Tobramycin
- Dexamethasone
干预措施: Topical travoprost (Drug)
2 micro-bypass stents & travoprost
Other
Two iStent inject micro-bypass stents and topical travoprost
Intervention:
- Implantation of two iStent inject micro-bypass stents
- Tobramycin
- Dexamethasone
干预措施: Two iStent inject micro-bypass stents (Device)
2 micro-bypass stents & travoprost
Other
Two iStent inject micro-bypass stents and topical travoprost
Intervention:
- Implantation of two iStent inject micro-bypass stents
- Tobramycin
- Dexamethasone
干预措施: Tobramycin (Drug)
2 micro-bypass stents & travoprost
Other
Two iStent inject micro-bypass stents and topical travoprost
Intervention:
- Implantation of two iStent inject micro-bypass stents
- Tobramycin
- Dexamethasone
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Mean intraocular pressure reduction of 20% or more versus baseline with reduction of 1 medication
时间窗: 12 months postoperative
次要结局
- Mean intraocular pressure of 18 mmHg or less versus baseline with reduction of 1 medication(12 months postoperative)
研究者
研究点 (1)
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