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OpenTrials
Completed

NCT Number: NCT02952365

Tissue Sealant Use in LASIK Enhancement Surgery

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

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Key information

Conditions

Age range

21 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Byers Eye Institute at Stanford

Palo Alto, California, 94303, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tissue sealant

Drug

Application of tissue sealant on eyes undergoing LASIK enhancement

Other names: ReSure sealant

Primary outcomes

  1. Slit Lamp Examination for Presence of Epithelial Ingrowth Under LASIK Flap

    Time frame: At post-operative month 3

    The number of eyes that developed epithelial ingrowth under LASIK flap

Secondary outcomes

  1. Change in Refraction

    Time frame: At post-operative month 3

    Number of eyes within 0.5 diopters of the intended correction

  2. Best-corrected Visual Acuity

    Time frame: At post-operative month 3

    Number of eyes losing 2 or more lines of corrected distance visual acuity measured by ETDRS testing charts

  3. Uncorrected Visual Acuity

    Time frame: At post-operative month 3

    Number of eyes with an uncorrected visual acuity of 20/20 at 12 months measured using ETDRS testing charts

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

A Prospective Evaluation of Tissue Sealant to Prevent Epithelial Ingrowth in Repeat LASIK Surgery

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 2, 2016
Registry last updated
Dec 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.