A Prospective, Observational, Consecutive, Qualitative, Multicenter Study Assessing Eye Drop Administration
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Proportion of patients who meet pre-specified "success" criteria for proper administration of eye drop onto ocular surface on first attempt session as evaluated by the ophthalmologist or optometrist grader
研究概览
简要总结
This is a prospective, observational, consecutive, qualitative, multicenter study. Based on the available published evidence that supports patient challenges with eyedrop administration, the purpose of this video-capture study is to evaluate a more real-world population of consenting patients, regardless of age, with or without visual impairment, at routine eyecare visits.
To date, no studies have been performed evaluating a real-world population consisting of daily routine eyecare clinic patients with or without visual impairment. This study will help to determine the ability to achieve success with self-administration of eyedrops in the real world.
详细描述
Introduction: This is a prospective, observational, consecutive, qualitative, multicenter study. A robust body of evidence suggests patients demonstrate challenges with eyedrop adherence and improper administration. The current standard of care following ophthalmic surgery is topical treatment with corticosteroids, antibiotics, and NSAIDs. Prospectively evaluated patients accuracy in administering eyedrops, during the post-operative period of cataract surgery, with 92.6% of patients demonstrating at least one type of improper administration technique. Few examples of possible errors included neglect of handwashing, failure to shake the eyedrop bottle, contamination of the bottle tip, incorrect amount of drops, and even missing the ocular surface entirely. Additionally, there was an incongruence between patient's impression of their technique and physician's observation. Thirty-five percent of patients who reported not missing the eye, did miss the eye under observation, and 39.3% of the patients who believed they never touched the eye with the bottle tip, did touch the ocular surface.
Similar studies were also performed in visually impaired patients due to glaucoma and retinal diseases with up to 47% of patients with retinal diseases touching the bottle to the eye, and up to 30% of patients not being able to administer a drop into the eye.
The objective of this study is to assess the accuracy of successful eye drop administration in patients undergoing routine exams.
This study also seeks to understand the discrepancy between patient impressions of eyedrop instillation success compared to success determined by ophthalmologist and optometrist evaluation.
Study Design This study will video capture adult subjects or Legal Authorized Representative (LAR) for minor subject's administration of one artificial tear onto the ocular surface. A temporal view video recording will be obtained. Subjects age 11 or older will self-administer the eye drops. Subjects age 10 or younger will have eye drops administer by the subject's LAR. Adult subjects or LAR will administer the drop with their dominant hand in the eye of the subject's preference.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients or parents of minor patients who consent to participating in the study
排除标准
- •Any patient who does not consent to study participation
研究组 & 干预措施
1
干预措施: Artificial Tears (Drug)
结局指标
主要结局
Proportion of patients who meet pre-specified "success" criteria for proper administration of eye drop onto ocular surface on first attempt session as evaluated by the ophthalmologist or optometrist grader
时间窗: There will be a total of three eye drop administration attempts - Two attempts occur on the first visit (Day 0)
Eye drop administration success = one drop accurately falling onto the ocular surface with single drop administration without the tip of the eye drop bottle touching the hands or eye (including the eyelid, conjunctiva, eyelashes)
次要结局
- Agreement between optometrist and ophthalmologist graders and patient eye drop administration "success" outcomes on first, second and third attempt sessions as measured by calculated Kappa statistic.(three eye drop administration attempts - Two attempts on the first visit (Day 0) and one attempt at second visit (Day 30 +/- 7 days))
- Proportion of patients who meet each individual failure criterion on first, second, and third attempt session(three eye drop administration attempts - Two attempts on the first visit (Day 0) and one attempt at second visit (Day 30 +/- 7 days).)
- Proportion of patient eye drop administration "success" as evaluated by patient self-assessment on first, second, and third attempt sessions(three eye drop administration attempts - Two attempts on the first visit (Day 0) and one attempt at second visit (Day 30 +/- 7 days).)