Can Pregabalin Reduce the Frequency and Severity of Dry Eye Symptoms After Laser-assisted in Situ Keratomileusis?
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Severity of Dry Eye Symptoms as Assessed by the Dry Eye Questionnaire - 5 (DEQ5)
研究概览
简要总结
Can Lyrica (Pregabalin) help prevent severe Dry Eye post LASIK surgery?
详细描述
Dry eye symptoms can occur after LASIK surgery. They generally get better with time but in some patients, they can persist. The investigators believe that in some individuals, dry eye symptoms after LASIK persist because the nerves in the cornea become hypersensitive. The investigators wish to study if a medication, called pregabalin, can protect corneal nerves at the time of LASIK surgery and decrease the frequency and severity of dry eye symptoms 6 months after surgery. This medication has been used in a similar way to reduce the frequency of uncomfortable sensations after other surgeries (knee, abdomen) but has never been studied in LASIK surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 and 65 years of age
- •undergoing LASIK (unilateral or bilateral procedure).
- •Females of child-bearing age will need a negative urine or serum pregnancy test at the screening visit.
- •ocular and systemic medication regimen has been stable for 3 months
排除标准
- •Pregnant or lactating, participating in another study with an investigational drug within one month prior to screening
- •Using gabapentin, pregabalin, anti-convulsants, duloxetine, venlafaxine (SNRI), or tri-cyclic antidepressants
- •have a history of allergic, anaphylactic reaction, or severe systemic response to pregabalin or gabapentin
- •use corticosteroids chronically or during the month prior to surgery, or have a history of corneal disease (HSV or varicella zoster keratitis, prior corneal incisions (cataract surgery, radial keratotomy, LASIK), prior corneal ulcer).
- •patients with systemic co-morbidities that may confound DE such as HIV, sarcoidosis, graft-versus host disease or a collagen vascular disease.
- •Adults unable to consent
- •Individuals who are not yet adults (infants, children, teenagers)
- •Prisoners
研究组 & 干预措施
Pregabalin
Pregabalin 150 mg twice a day starting 1 day prior to LASIK and continuing for 14 days total.
干预措施: Pregabalin (Drug)
Placebo
Placebo pill twice a day starting 1 day prior to LASIK and continuing for 14 days total.
干预措施: Placebo (Drug)
结局指标
主要结局
Severity of Dry Eye Symptoms as Assessed by the Dry Eye Questionnaire - 5 (DEQ5)
时间窗: 6 months
DEQ5 total score ranges from 0-22 with the higher scores indicating increased dry eye. Absolute score will be reported from DEQ5 questionnaire completed at 6 month visit.
次要结局
- Dry Eye Symptoms as Evaluated by the Ocular Surface Disease Index (OSDI)(3 months, 6 months)
- Tear Production Measured by Schirmers Score(3 months, 6 months)
- Eye Pain as Evaluated by the Neuropathic Pain Symptom Inventory - Eye (NPSI-E)(3 months, 6 months)
- Tear Evaporation Measured by Tear Break up Time (TBUT)(3 months, 6 months)
- Eye Pain as Assessed by the Short Form - McGill Pain Questionnaire (Sf-MPQ) Sensory(3 months, 6 months)
- Eye Pain as Assessed by the Short Form - McGill Pain Questionnaire (Sf-MPQ) Affective(3 months, 6 months)
- Eye Pain as Assessed by the Numeric Rating Scale (NRS)(3 months, 6 months)
研究者
Anat Galor
Associate Professor of Clinical Ophthalmology
University of Miami