Clinical trial NCT02952365: Tissue Sealant Use in LASIK Enhancement Surgery
Official title: A Prospective Evaluation of Tissue Sealant to Prevent Epithelial Ingrowth in Repeat LASIK Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Epithelial Ingrowth
Keywords: LASIK, Ingrowth, Tissue sealant
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2016-11-02
Enrollment: 2
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Subjects age 21 and older
* Subjects with healthy eyes
* Subjects who have previously undergone LASIK surgery
* Subjects with residual refractive error.

Exclusion Criteria:

* Subjects under the age of 21.
* 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.

Primary outcomes:
measure: Slit Lamp Examination for Presence of Epithelial Ingrowth Under LASIK Flap
timeFrame: At post-operative month 3
Secondary outcomes:
measure: Change in Refraction
timeFrame: At post-operative month 3
measure: Best-corrected Visual Acuity
timeFrame: At post-operative month 3
measure: Uncorrected Visual Acuity
timeFrame: At post-operative month 3
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Byers Eye Institute at Stanford
state: California
Study officials:
affiliation: Stanford University
name: Edward E Manche, MD
role: PRINCIPAL_INVESTIGATOR
References: