Clinical Evaluation of Morcher Artificial Iris Diaphragms to Treat Light and Glare Sensitivity in Partial or Complete Aniridia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Change in Light and Glare Sensitivity as Determined by a Clinical Glare Test (Primary Efficacy Measure)
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of Morcher iris diaphragms in the treatment of congenital and acquired aniridia. Morcher iris diaphragms are intraocular devices that are designed to provide an artificial pupil for patients suffering from partial or complete aniridia. These devices are constructed from clinical quality, ultraviolet light-absorbing, opaque black polymethylmethacrylate (PMMA). After surgical implantation, patients are monitored over the course of 1 year to measure any changes to visual acuity and improvements in light and glare sensitivity.
详细描述
Aniridia is a condition in which the iris, the colored portion of the eye, is either partially or completely absent. The iris is responsible for regulating the amount of light entering the eye by adjusting the size of the pupil.
Aniridia can either be a congenital condition, often a genetically-based abnormality affecting the formation of the iris, or it can be acquired by blunt trauma with or without rupture, penetrating trauma, or severe intraocular inflammation.
Aniridia can also vary in the level of severity. A mild case might involve a thinner iris or iris remnant with a normal pupil. A severe case might involve complete absence of the iris or impairment of the muscles responsible for adjusting pupil size.
Iris defects can occur without the loss of stromal tissue as well. In some cases, the iris pigment epithelium is missing. In other cases, holes are present in the iris or the pupil is chronically enlarged or mydriatic.
People who suffer from iris defects also commonly suffer from other eye conditions. Common comorbidities include glaucoma, cataract, and nystagmus. Other structures in the eye are often affected, including the cornea, crystalline lens, zonules, and retina. Iris defects can cause severe visual disability if untreated.
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
- •Patient must be 18 years old and have partial or complete aniridia.
- •Be willing and able to comply with all follow-up requirements.
- •Must have increased light and/or glare sensitivity or complete aniridia.
- •Patients may be phakic, aphakic, or pseudophakic.
- •Phakic patients will require simultaneous cataract surgery.
- •Aphakic patients will require secondary intraocular lens implantation.
排除标准
- •The presence of any ocular condition that may cause complications from the surgical procedure
- •Active ocular infection or inflammation
- •Patients with allergies to operative and/or postoperative medications
- •Pregnant or lactating women
- •Persons who, in the determination of the investigator, are not competent to understand the procedure or the actions asked of them as research subjects
结局指标
主要结局
Change in Light and Glare Sensitivity as Determined by a Clinical Glare Test (Primary Efficacy Measure)
时间窗: Preoperatively and 1 year postoperatively
The primary efficacy measure of the study was the change in corrected distance visual acuity (CDVA) under glare conditions. A transilluminator light was held just in front of the distance corrected study eye in one of four quadrants (above, below, nasal, or temporal) to the line of sight to evoke a glare response. The direction that produced the worst CDVA was called the CDVA with glare. A ≥ 2 line improvement in Snellen CDVA with glare following Morcher device implantation was considered a positive clinical change (glare sensitivity better). A ≥ 2 line worsening of Snellen CDVA with glare following Morcher device implantation was considered a negative clinical change (glare sensitivity worse). A change of \< 2 Snellen lines following Morcher device implantation was considered to be a neutral change (glare sensitivity the same).
Change in Best Corrected Visual Acuity (Primary Safety Measure)
时间窗: Preoperatively and 1 year postoperatively
The primary safety measure of the study was the change in best corrected distance visual acuity (CDVA) as measured using a Snellen eye chart. A ≥ 2 line improvement in Snellen CDVA following Morcher device implantation was considered a positive clinical change (visual acuity better). A ≥ 2 line worsening of Snellen CDVA following Morcher device implantation was considered a negative clinical change (visual acuity worse). A change of \< 2 lines was considered to be a neutral change (visual acuity the same).
次要结局
- Change in Glare Sensitivity Under Day Time Lighting Conditions (Secondary Efficacy Measure)(Preoperatively and 3 months postoperatively)
- Change in Glare Sensitivity Under Night Time Lighting Conditions (Secondary Efficacy Measure)(Preoperatively and 3 months postoperatively)
- Change in Endothelial Cell Count (Secondary Safety Measure)(Preoperatively and 3 months postoperatively)
- Need to Explant or Exchange a Morcher Iris Diaphragm (Secondary Safety Measure)(Preoperatively and 1 year postoperatively)
研究者
Kevin M. Miller, MD
Kolokotrones Chair in Ophthalmology
University of California, Los Angeles