NCT05518344终止不适用
Clinical Investigation of "Viziatek ISL™ Refractive Phakic Intra Sulcus Lens" for Refraction Adjustment in Blind Volunteers
Hanita Lenses1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2020年6月4日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Endothelial cell loss
研究概览
简要总结
This is a clinical investigation. A total of up to 5 subjects, but not less than 3 at one investigational site will undergo insertion of the ISL in one eye and will be followed through 6 months postoperative.
Subjects from the United States will not be enrolled in this study.
详细描述
The Viziatek ISL is intended to improve myopic vision and decrease dependence on glasses in myopic adults who don't have an irregular astigmatic cornea (as evaluated by topography), who require correction of -3.50 D to -23 D, who have BCVA - Distance between 20/20 to 20/30 and with no more than 5 D of the refractive cylinder, and who have stable MRSE within 0.50 D over the past 12 months.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must sign and be given a copy of the signed Informed Consent Form (ICF).
- •Subjects must be legally blind.
- •Subjects must have best-corrected distance visual acuity of 20/400 or worse.
- •Subjects must have an endothelial cell count ≥ 1800 cells/mm2 in the eye to be implanted.
- •Subjects must have a photopic pupil size of > 2 mm in the eye to be implanted.
- •Anterior chamber depth (ACD) ≥ 2.8 mm
- •Anterior chamber angle ≥ Grade III
- •Subjects must be willing and able to return for scheduled follow-up examinations for 12 months after surgery if asked.
排除标准
- •Subjects who have best-corrected visual acuity of better than 20/400
- •Subjects with clinically significant anterior segment pathology, including cataracts, in either eye.
- •Subjects with residual, recurrent, active ocular or uncontrolled eyelid disease or any progressive corneal abnormalities (including endothelial dystrophy, guttate in the central cornea, etc.) in the eye to be treated.
- •Subjects with a history of the chronic dry eye not controlled on therapy or with superficial punctuate keratitis (SPK) grade > II (i.e., greater than mild) based on Oxford Grading Scale12 in the eye to be treated.
- •Subjects who have undergone previous intraocular or corneal surgery including cataract and refractive surgery (e.g., LASIK surgery) in either eye.
- •Subjects using ophthalmic medication(s) other than artificial tears for treatment of ocular pathology.
- •Subjects with a history of autoimmune disease, connective tissue disease, or clinically significant atopic syndrome.
- •Subjects with a history of herpes zoster or herpes simplex keratitis.
- •Subjects with a history of a steroid-responsive rise in intraocular pressure (IOP), or a preoperative IOP > 21 mmHg or glaucoma.
- •Subjects with distorted, non-reactive, or decentered pupils.
- •Subjects on chronic systemic or topical corticosteroids or other immunosuppressive therapy that may affect wound healing, and any immuno-compromised subjects (use of intranasal steroids for seasonal allergies are acceptable).
- •Subjects using systemic medications with significant ocular side effects.
- •Subjects who are pregnant or are considering becoming pregnant during the time of the study.
- •Subjects with known sensitivity to planned study concomitant medications.
- •Subjects who are participating in any other drug or device clinical investigation.
研究组 & 干预措施
single arm
Experimental
- Release ISL from Inserter
- Remove Inserter.
- Tack the haptics under the iris in 4 locations
- Verify that ISL is centered
- Remove lid speculum and drape from subject's eye and face.
- Move the subject to a slit lamp and verify ISL centration.
干预措施: Viziatek ISL™ (hereinafter referred to as the "ISL") implanted in blind eye. (Device)
结局指标
主要结局
Endothelial cell loss
时间窗: 6 months
Endothelial cell loss in operated eye measured at months 6, and change in cell count from baseline less than 10%.
次要结局
- Ultrasound Biomicroscopy (UBM)(6 months)
研究者
研究点 (1)
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