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Tissue Sealant Use in LASIK Enhancement Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02952365
Recruitment Status : Completed
First Posted : November 2, 2016
Results First Posted : December 14, 2021
Last Update Posted : December 14, 2021
Information provided by (Responsible Party):
Edward E. Manche, Stanford University

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

Condition or disease Intervention/treatment Phase
Epithelial Ingrowth Drug: Tissue sealant Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Prospective Evaluation of Tissue Sealant to Prevent Epithelial Ingrowth in Repeat LASIK Surgery
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : May 22, 2017
Actual Study Completion Date : May 22, 2017

Arm Intervention/treatment
Eyes undergoing LASIK enhancement
Eyes undergoing LASIK enhancement will have tissue sealant applied to the eye to prevent epithelial ingrowth
Drug: Tissue sealant
Application of tissue sealant on eyes undergoing LASIK enhancement
Other Name: ReSure sealant

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02952365

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United States, California
Byers Eye Institute at Stanford
Palo Alto, California, United States, 94303
Sponsors and Collaborators
Stanford University
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Principal Investigator: Edward E Manche, MD Stanford University
  Study Documents (Full-Text)

Documents provided by Edward E. Manche, Stanford University:
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Responsible Party: Edward E. Manche, Principal Investigator, Stanford University Identifier: NCT02952365    
Other Study ID Numbers: IRB-38495
First Posted: November 2, 2016    Key Record Dates
Results First Posted: December 14, 2021
Last Update Posted: December 14, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Edward E. Manche, Stanford University:
LASIK, Ingrowth, Tissue sealant