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Tissue Sealant Use in LASIK Enhancement Surgery

NCT ID: NCT02952365

Last Updated: 2021-12-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-01

Study Completion Date

2017-05-22

Brief Summary

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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

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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.

Conditions

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Epithelial Ingrowth

Keywords

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LASIK, Ingrowth, Tissue sealant

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Eyes undergoing LASIK enhancement

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

Group Type OTHER

Tissue sealant

Intervention Type DRUG

Application of tissue sealant on eyes undergoing LASIK enhancement

Interventions

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Tissue sealant

Application of tissue sealant on eyes undergoing LASIK enhancement

Intervention Type DRUG

Other Intervention Names

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ReSure sealant

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Edward E. Manche

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Edward E Manche, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Byers Eye Institute at Stanford

Palo Alto, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IRB-38495

Identifier Type: -

Identifier Source: org_study_id