Lacritin and Heparanase Levels in Human Tears After Laser Refractive Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- The primary outcome measure is tear lacritin levels pre- and post-surgery.
研究概览
简要总结
The purpose of this study is to measure tear lacritin and heparanase levels before and following surgery using a minimal risk procedure to collect tears from patients undergoing PRK or LASIK.
详细描述
Lacritin is a naturally occurring tear protein with antimicrobial activity that is capable of stimulating mitogenesis in human corneal epithelial cells and promoting production of tears in lacrimal gland acinar cells. A recently developed immunoassay for lacritin may help characterize the lacritin response following refractive surgery with the possible development of recombinant lacritin as a novel therapeutic agent for wound healing. Heparanase (HPSE) acts as a regulator for lacritin by cleaving heparan sulfate chains and allowing lacritin to bind. We aim to measure both tear lacritin and HPSE pre- and post-operatively to elucidate lacritin and HPSE's response in patients undergoing PRK (photorefractive keratectomy) and LASIK (Laser-assisted in situ keratomileusis) at the Walter Reed Center for Refractive Surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Active duty US Army Soldiers eligible for care at FBCH
- •Undergoing PRK or LASIK
- •Male or female, of any race, and at least 21 years old and not older than 55 years old at the time of the tear collection. The lower age limit of 21 years is intended to ensure documentation of refractive stability.
- •Appropriately aged individuals who report that their eyes are "normal" and who have no active eye illness as determined by the principal investigator or sub-investigator.
- •Ability and willingness to understand and provide informed consent to participate in this study.
- •Up to -10.00 diopters of myopia.
- •Subject must expect to be located in the greater Washington DC area for a 12 month period post-operatively.
- •Consent of the subject's command (active duty) to participate in the study.
- •Access to transportation to meet follow-up requirements.
排除标准
- •Any reason to be excluded for PRK or LASIK
- •Female subjects who are pregnant, breast-feeding or intend to become pregnant during the study. Female subjects will be given a urine pregnancy test prior to participating in the study to rule out pregnancy. [Pregnancy and breastfeeding are contraindications to refractive surgery in general, including PRK, whether participating in this study or not]
- •Patients with known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course.
- •Any physical or mental impairment that would preclude participation in any of the examinations.
- •Anterior basement membrane dystrophy
- •History of recurrent epithelial erosion
- •Significant dry eye (symptomatic with Schirmer <5mm at 5 minutes)
- •Other corneal epithelial disorder or healing abnormality
- •Individuals with any infectious or inflammatory ocular conditions (e.g. have "pink eye" or uveitis).
- •Individuals diagnosed with dry eye or other ocular surface condition, including but not restricted to neurotropic keratitis, anterior basement membrane dystrophy, and recurrent corneal erosions.
结局指标
主要结局
The primary outcome measure is tear lacritin levels pre- and post-surgery.
时间窗: pre and standard visits up to 6 months post-surgery
次要结局
- The secondary outcome is tear heparanase levels pre- and post-surgery(pre- and at standard visits up to 6 months post-surgery)
研究者
COL Bruce Rivers
Director, Warfighter Refractive Eye Surgery Program and Research Center at FT Belvoir
Fort Belvoir Community Hospital