A Prospective Evaluation of Tissue Sealant to Prevent Epithelial Ingrowth in Repeat LASIK Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Slit Lamp Examination for Presence of Epithelial Ingrowth Under LASIK Flap
研究概览
简要总结
The purpose of the study is to evaluate the use of prophylactic tissue sealant to prevent epithelial ingrowth from gaining access under a LASIK flap with repeat LASIK surgery
详细描述
Participants will have a comprehensive eye examination once they express an interest in the study. This includes a slit lamp examination of the front of the eye and a dilated fundoscopic examination of the back of the eye. If there is any pathology noted that would exclude the participant from the study, then the participant will be informed and given an appropriate referral. If the participant is deemed appropriate for the study after a comprehensive examination included computerized videokeratography, then they can be enrolled. The participant will undergo LASIK flap lift eye surgery.
Tissue sealant will be applied at to the edge of the LASIK flap at the conclusion of the surgery. A bandage contact lens will also be placed. The bandage contact lens is used in the usual and customary fashion as in non-study LASIK flap lift surgery.
The participants will be seen on the day of surgery, post op day one, one month, and three months. The participant will receive topical antibiotics in each eye for one week following the procedure. The participant will receive pred forte 1% ophthalmic drops for one week after treatment. The participant will also receive vigamox ophthalmic drops for seven days after treatment. All of this is within the usual and customary standard of care for the treatment of participants undergoing LASIK surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects age 21 and older
- •Subjects with healthy eyes
- •Subjects who have previously undergone LASIK surgery
- •Subjects with residual refractive error.
排除标准
- •Subjects under the age of
- •Subjects with excessively thin corneas.
- •Subjects with topographic evidence of keratoconus.
- •Subjects with ectatic eye disorders.
- •Subjects with autoimmune diseases.
- •Subjects who are pregnant or nursing.
研究组 & 干预措施
Eyes undergoing LASIK enhancement
Eyes undergoing LASIK enhancement will have tissue sealant applied to the eye to prevent epithelial ingrowth
干预措施: Tissue sealant (Drug)
结局指标
主要结局
Slit Lamp Examination for Presence of Epithelial Ingrowth Under LASIK Flap
时间窗: At post-operative month 3
The number of eyes that developed epithelial ingrowth under LASIK flap
次要结局
- Change in Refraction(At post-operative month 3)
- Best-corrected Visual Acuity(At post-operative month 3)
- Uncorrected Visual Acuity(At post-operative month 3)
研究者
Edward E. Manche
Principal Investigator
Stanford University