跳至主要内容
临床试验/NCT04583579
NCT04583579终止不适用

Maximizing the Initial Experience of a Neophyte Scleral Lens Wearer

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2021年2月23日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrew Pucker

Assistant Professor

University of Alabama at Birmingham

研究点 (2)

Loading locations...

相似试验