Safety and Efficacy of the Slit Stent II Lacrimal Stent for the Treatment of Nasolacrimal Duct Obstruction
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Safety, as Measured by Number of Subjects With at Least One Adverse Event
研究概览
简要总结
This project aims to test whether a newly designed lacrimal stent - the SlitStent - when placed into the lacrimal system in the standard fashion following a DCR surgery, will provide good symptomatic relief for epiphora and be well tolerated.
Epiphora, or severe tearing, is both a very common debilitating symptom and a potential cause of dangerous infections (i.e. dacryocystitis and orbital cellulitis). DCR+lacrimal stenting surgery is 80-95% successful at improving epiphora, and the longer the stent remains in place, the better the long-term outcome. However, lacrimal stents that provide adequate circumferential force to facilitate post-DCR healing also occupy space and prevent good tear drainage until removed. Yet patients want complete symptomatic improvement as soon as possible, even if it compromises long-term results.
This study aims to test a newly designed lacrimal stent that allows tears to drain through the lumen of the stent. The new stent is constructed by modifying a commercially available stent by placing openings along the side of the stent using a process developed by a University of Michigan engineer/collaborator. Following slit placement, the stent will be gas-sterilized for surgery. Patient who are scheduled for DCR+stenting surgery who provide informed consent will be randomized 2:1 to receive the investigational SlitStent or the standard commercially available stent. Following surgery, patients will be assessed both clinically, which is standard of care, and via a patient questionnaire.
详细描述
This is a single center study that will be conducted at the University of Michigan (Ann Arbor, Michigan). Fifty (50) subjects will be enrolled and treated with either the experimental Slit Stent II or the control stent BIKA for DCR. Patients who are currently scheduled to undergo a DCR (dacryocystorhinostomy) as per standard of care will be offered participation in the study. Patients who elect to participate in the study will be consented and then randomized to the treatment or control arm.
A lacrimal stent is hollow silicone tubing with a non-traumatic tip. The tubing is securely attached into malleable stainless steel probes that are used to guide the silicone tubing through the lacrimal drainage apparatus. The device is used to maintain an open lacrimal path between the surface of the eye and the nasal passages, particularly during a healing process following injury or surgery.
The BIKA for DCR lacrimal stent is a bicanalicular intubation device used for intubation of the lacrimal drainage apparatus, especially in cases of dacryocystorhinostomy (conventional or laser). The silicone tube acts as a conformer during the healing process while facilitating drainage of tears through capillary action around the stent. In cases of canalicular lacerations, the silicone tube guides wound healing and prevents the onset of synechia.
The BIKA lacrimal stent consists of a single unit including a silicone tube (length: 280 mm, external diameter: 0.94 mm), and one steel probe at each end of the silicone tube (length: 53 mm, external diameter: 0.8 mm) with round tips.
The BIKA for DCR is a sterile, single-use device, and is an FDA cleared device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willingness and ability to comply with schedule for follow-up visits and postoperative evaluations.
- •Eligible for unilateral DCR surgery with stenting for treatment of epiphora secondary to nasolacrimal duct obstruction.Ability to instill post-operative eye drop
- •Signed written, informed consent.
排除标准
- •Subjects under legal guardianship or who, in the investigator's opinion, lack the mental capacity to provide written informed consent for study participation.
- •Subjects scheduled for bilateral DCR surgery
- •Subjects with known sensitivity to silicone
- •Subjects with a current condition that, in the investigator's opinion, would interfere with the treatment.
- •Inability to use eye drops
- •Subjects with a known sensitivity to required study medications (e.g. antibiotic drops) if an alternative medication is not available.
研究组 & 干预措施
Slit Stent II
The Slit Stent II (investigational) device is created by modifying an existing FDA cleared lacrimal stent (BIKA, manufactured by FCI Opthalmics) by adding additional 3 mm and 35 mm long slits of equal depth.
干预措施: Slit Stent II (Device)
BIKA for DCR
The BIKA for DCR is a sterile, single-use device, and is an FDA cleared device.
干预措施: BIKA for DCR (Device)
结局指标
主要结局
Safety, as Measured by Number of Subjects With at Least One Adverse Event
时间窗: Surgery to final exit visit (Month 4-7)
Adverse events will be recorded from the time of surgical implantation of the device until the final visit. Ophthalmic complications or adverse events that are observed by the investigator or reported by the subject will be recorded on the CRFs. For all adverse effects, sufficient information will be pursued and/or obtained so as to permit 1) an adequate determination of the outcome of the effect (i.e., whether the effect should be classified as a serious adverse effect) and; 2) an assessment of the causal relationship between the adverse effect and the investigational device or, if applicable, the other study treatment or diagnostic product(s).
次要结局
- Glasgow Benefit Inventory (GBI) Questionnaire (Quality of Life)(1-4 month post-operative follow-up visit)
- Lac-Q Score(1-4 months post operative)
研究者
Thomas Gardner
Professor of Ophthalmology and Visual Science and Molecular and Integrative Physiology
University of Michigan