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Tissue Sealant Use in LASIK Enhancement Surgery

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ClinicalTrials.gov Identifier: NCT02952365
Recruitment Status : Recruiting
First Posted : November 2, 2016
Last Update Posted : March 17, 2021
Sponsor:
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)
Estimated Enrollment : 25 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 2016
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : January 2023

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 [ Time Frame: Three months ]
    Presence of epithelial ingrowth under LASIK flap



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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
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.

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 ClinicalTrials.gov identifier (NCT number): NCT02952365


Contacts
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Contact: Edward E Manche, MD 650 498-7020 lasik.manche@stanford.edu
Contact: Linda Schwartz 650 498-7020 lschwartz@stanfordhealthcare.org

Locations
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United States, California
Byers Eye Institute at Stanford Recruiting
Palo Alto, California, United States, 94303
Contact: Edward E Manche, MD    650-498-7020      
Principal Investigator: Edward E Manche, MD         
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Edward E Manche, MD Stanford University
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Responsible Party: Edward E. Manche, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT02952365    
Other Study ID Numbers: IRB-38495
First Posted: November 2, 2016    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Edward E. Manche, Stanford University:
LASIK, Ingrowth, Tissue sealant