Tissue Sealant Use in LASIK Enhancement Surgery

Stanford University

Status and phase: Completed; Phase 4

Conditions: Epithelial Ingrowth

Treatments: Drug: Tissue sealant

Study type: Interventional

Funder types: Other

Identifiers

NCT02952365

IRB-38495

Details and patient eligibility

About

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

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 21 to 99 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Eyes undergoing LASIK enhancement

Other group

Description:

Eyes undergoing LASIK enhancement will have tissue sealant applied to the eye to prevent epithelial ingrowth

Treatment:

Drug: Tissue sealant