RECRUITING

A Study to Assess the Efficacy of Kera Sol Tears on Signs and Symptoms of Surgical Temporary Ocular Discomfort Syndrome (STODS) in Subjects Following LASIK

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Collecting data using Kera Sol tear usage during the initial two-week post-operative period after Laser-Assisted In Situ Keratomileusis (LASIK) has on the signs and symptoms of surgical temporary ocular discomfort syndrome (STODS)

Official Title

Kera Sol Post-LASIK: A Benefit Study

Quick Facts

Study Start:2025-08-01
Study Completion:2026-02-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07155070

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Be willing and able to sign the informed consent form (ICF)
  2. * Be at least 18 years of age at the screening visit
  3. * Be undergoing LASIK treatment in both eyes
  4. * Be literate and able to complete questionnaires independently
  5. * Be able and willing to use the study drug and participate in all study assessments and visits
  6. * Have provided verbal and written informed consent
  1. * Use of topical prescription dry eye medications such as lifitegrast, cyclosporine, loltilaner, etc.
  2. * Have a break in the integrity of the corneal epithelium such as a persistent corneal epithelial defect, or corneal ulcer.
  3. * Have presence of corneal pathology that may interfere with LASIK outcomes
  4. * Active infectious, ocular or systemic disease
  5. * Have a history of ocular inflammation or macular edema
  6. * Have had clinically significant active infectious keratitis in the past 3 months 7. -Have history of prior refractive surgery
  7. * Have placement of temporary punctal plugs in the past 1 month or current presence of permanent punctal plugs at time of screening
  8. * Patients with usual relative and absolute contraindications for LASIK surgery (Patients with severe dry eye, recurrent corneal erosion, uncontrolled Glaucoma, collagen vascular disorders, keratoconus or signs of keratoconus, uncontrolled Diabetes, Herpes)
  9. * Autoimmune or immunodeficiency diseases
  10. * Pregnant or nursing women
  11. * Patients with history of previous ocular surgery

Contacts and Locations

Study Contact

Tiffany Facile
CONTACT
605-371-7075
tiffany.facile@vancethompsonvision.com

Study Locations (Sites)

Vance Thompson Vision Clinic, Prof. LLC
Sioux Falls, South Dakota, 57108
United States

Collaborators and Investigators

Sponsor: Vance Thompson Vision

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-01
Study Completion Date2026-02-01

Study Record Updates

Study Start Date2025-08-01
Study Completion Date2026-02-01

Terms related to this study

Additional Relevant MeSH Terms

  • Surgical Temporary Ocular Discomfort Syndrome