NL-OMON56815尚未招募不适用
A Prospective, Multicenter, Randomized Clinical Trial to Evaluate the Safety and Effectiveness of ELIOS Compared to iStent inject W in Patients with Open-Angle Glaucoma Undergoing Cataract Surgery - ELIOS-RCT
ELIOS Vision Inc0 个研究点目标入组 14 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 14
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Patients are eligible for inclusion in this clinical trial if all the following
- •criteria apply. Ocular criteria pertain to the study eye only.
- •1. Male or female subjects;
- •2. 40 years old or older;
- •3. Diagnosis of mild to moderate primary open-angle glaucoma, pseudoexfoliation
- •glaucoma or pigmentary glaucoma
- •a. Glaucomatous optic nerve damage as evidenced by any of the following optic
- •disc or retinal nerve fiber layer structural abnormalities:
- •i. Diffuse thinning, focal narrowing or notching of the optic disc rim,
- •especially at the inferior or superior poles with or without disc hemorrhage;
- •ii. Localized abnormalities of the peripapillary retinal nerve fiber layer,
- •especially at the inferior or superior poles; or
- •iii. Optic disc neural rim asymmetry of the two eyes consistent with loss of
- •neural tissue
- •b. Cup-to-disc (C/D) ratio < 0.9
- •4. Visually significant cataract eligible for phacoemulsification;
- •5. Clear cornea on biomicroscopy.
- •6. Unmedicated (washout) mean diurnal IOP >= 22 mmHg and <= 34 mmHg at Baseline
- •7. Trabecular meshwork visible on gonioscopy, with Shaffer angle grade >= II in
- •all quadrants;
- •8. Presence of glaucomatous field defect with a mean deviation not worse than
- •-12 dB on a reliable, interpretable visual field examination using Humphrey
- •SITA Standard 24-2 visual hemifield analysis.
- •Note: The Humphrey VF should be reliable, defined as fixation
- •losses, false positives, and false negatives all less than 33%;
- •9. Sufficient cognitive awareness and willingness to follow study instructions,
- •agreed compliance with all study procedures, and willingness and ability to
- •return for all scheduled examinations for 24 months postoperatively;
- •10. Ability to provide written informed consent.
排除标准
- •A subject who meets any of the criteria listed below will be excluded from the
- •study. Ocular criteria pertain to the study eye only unless otherwise
- •1. All forms of angle closure glaucoma;
- •2. Secondary glaucoma, including traumatic, neovascular, uveitic, lens-induced,
- •steroid-induced, angle-recession, glaucoma associated with vascular disorders,
- •and glaucoma associated with increased episcleral venous pressure;
- •3. Congenital or developmental glaucoma;
- •4. Prior incisional glaucoma surgery, intraocular surgery or ocular laser
- •treatment of any type (e.g., argon laser trabeculoplasty [ALT], non-laser
- •retinal surgery, cyclodestructive procedure, scleral buckling procedure,
- •silicone oil use, etc.) with the exception of SLT occurring a minimum of 6
- •months prior to the Screening visit;
- •5. Prior iridectomy or laser iridotomy;
- •6. Clinically significant previous trauma to the eye, including chemical burn;
- •7. Subjects who cannot undergo a medication *washout* in the study eye or who
- •are at high risk for adverse outcomes, as determined by the investigator,
- •Subjects requiring oral ocular hypotensive medication (e.g., acetazolamide)
- •for IOP control or subjects
- •Severe glaucoma in the fellow eye, defined by:
- •o On pattern deviation (PD) plot, having greater than or equal to 75% of points
- •depressed below the 5% level and greater than or equal to 50% of points
- •depressed below 1% level; or
- •o Having at least 50% of points (i.e., 2 or more) within central 5 degrees with
- •sensitivity of < 0 dB on the dB plot; or
- •o Having points within the central 5 degrees of fixation with sensitivity < 15
- •dB in both hemifields on the dB plot
- •Subjects with BCVA of 20/200 or worse in the study eye due to glaucoma
- •With fixation-threatening glaucoma in either eye noted at the Screening
- •Visit: Subjects with visual field defects threatening fixation defined as any
- •(1 or more) point(s) within the central 5° depressed below the 5th percentile
- •on PD plot unless this/these points are >25 dB on Threshold Values (decibel)
- •8. Clinically significant ocular inflammation or infection within 30 days prior
- •to the Screening visit (e.g., blepharitis, conjunctivitis, keratitis);
- •9. Previous or current diagnosis of ophthalmic herpes simplex virus;
- •10. History of corneal surgery (including corneal refractive surgery), visually
- •significant corneal opacities, active inflammation, or any corneal
- •disease/pathology (e.g., Fuchs* dystrophy);
- •11. Presence of peripheral anterior synechiae (PAS) or other angle
- •abnormalities in the area of intended treatment;
- •12. Rubeosis;
- •13. Iridocorneal endothelial syndrome;
- •14. Epithelial or fibrous downgrowth;
- •15. Presence of extensive iris processes that obscure visualization of the
- •trabecular meshwork in area to be treated with laser;
- •16. Previous diagnosis of chronic or recurrent uveitis;
- •17. Active diabetic retinopathy, choroidal or iris neovascularization, branch
- •retinal vein occlusion, central retinal vein occlusion, proliferative
- •retinopathy, or other ophthalmic disease or disorder that could confound study
- •18. Diagnosed degenerative visual disorders (e.g., macular degeneration or
- •other retinal disorders);
- 另有 2 项未显示
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