Maximizing the Initial Experience of a Neophyte Scleral Lens Wearer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Scleral Lens Application Time
研究概览
简要总结
The goal of this proposal is to conduct a randomized controlled study aimed at learning the best method for applying scleral lenses and factors associated with successfully completing scleral lens application and removal training.
详细描述
Scleral lens (SL) prescribing has dramatically increased over the past few years likely because of the advent of better SL designs, better materials, and greater awareness of the technology. SL market growth has also likely increased because SLs were once reserved for patients with complex ocular surface diseases, though advances with SL technologies have allowed SL fitting to include patients with dry eye and even patients who have relatively uncomplicated refractive errors. While SLs are maintained and cared for much like soft contact lenses (e.g., they require a contact lens care system), SL wearers also need help with applying their lenses. Patients specifically are advised by their care provider to insert their SLs with their fingers (tripod method), a DMV inserter with an open or closed end (hole potentially aides in vision), or a specialized o-ring that is balanced on a finger. Our clinic also utilizes a tea light candle with a DMV inserter attached to the top of it when patients have mobility issues. While work from this investigator's study group has found that 54% of patients prefer DMV inserters for applying their SLs as compared to the above other options, these preliminary data were obtained through a cross-sectional electronic survey from subjects who completed their SL fitting up to two years ago. Therefore, the goal of this proposal is to conduct a randomized controlled study aimed at learning the best method for applying SLs and factors associated with successfully completing SL application and removal training. These data are needed because it will help practitioners with patient education and because it may increase the likelihood that patients will be successful with SLs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Adults (>18 years)
- •Must have an indication for needing scleral lenses
排除标准
- •Participating in another research study
- •Unable to attend multiple visits
- •Advanced knowledge or past use of scleral lenses
- •A physical or mental condition that would prevent the subject from applying their own scleral lenses
结局指标
主要结局
Scleral Lens Application Time
时间窗: At Dispense Visit at Hour 0 (Visit 2)
Amount of time needed to apply scleral lenses to both eyes (minutes); each patient will try each application method in a random order.
次要结局
- Subject's Method Preference(At Dispense Visit at Hour 0 (Visit 2))
研究者
Andrew Pucker
Assistant Professor
University of Alabama at Birmingham
