RECRUITING

Patient Reported Outcomes With WaveLight Plus LASIK

Talk to us

Conditions

MyopiaAstigmatism

Quick Navigation

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

This study is a single-site, single-arm, prospective, observational study of subject satisfaction, quality of vision, and quality of life after bilateral LASIK surgery. Subjects will be assessed up to 3 months post-operatively. Clinical evaluations will include refractive outcomes, visual acuity, and administration of the adapted PROWL and the Quality-of-Life Impact of Refractive Correction (QIRC) Questionnaire.

Official Title

Patient Reported Outcomes and Satisfaction With Wavelight Plus LASIK

Quick Facts

Study Start:2025-09-05
Study Completion:2026-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07084844

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 to 39 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Between the ages of 18 and 39
  2. * Meet the standard care requirements for LASIK
  3. * Spherical equivalent (SE) more than -1.00D and up to -9.00 diopters
  4. * Myopia ≤ -8.00 sphere (in minus cylinder format) and up to -3.00D astigmatism
  5. * SE difference between the manifest refraction and the Sightmap measured SE being less than 0.75D
  6. * Minimum residual stromal bed thickness of 250 µm
  7. * If currently wearing contact lenses:
  8. * Soft CTL wearers discontinue for minimum 3 days
  9. * RGP CTL wearers discontinue for 1 month per decade of wear
  10. * Stable refraction (2 consecutive manifest refractions within 0.25 SE)
  11. * Stable K readings (2 consecutive K readings in 2 consecutive visits)
  12. * Willing and able to complete all post-operative visits
  13. * Pre-surgery BCDVA of 20/20 (0.00 logMAR) or better in each eye.Mesopic pupil size ≥ 4.5mm
  1. * Subjects with any prior ocular surgery
  2. * Subjects with topographic evidence of keratoconus, or ectasia
  3. * Subjects with autoimmune diseases
  4. * Subjects who are pregnant or nursing
  5. * Systemic disease likely to affect wound healing, such as diabetes and severe atopy
  6. * Any ocular disease (including un-controlled dry eye) which in the investigator's opinion would affect the outcome of refractive surgery

Contacts and Locations

Study Contact

Study Coordinator
CONTACT
713-580-2500
Melissa.Wright@manneye.com

Principal Investigator

Phillip Brunson
PRINCIPAL_INVESTIGATOR
Mann Eye Institute

Study Locations (Sites)

Mann Eye Institute
Houston, Texas, 77004
United States

Collaborators and Investigators

Sponsor: Mann Eye Institute

  • Phillip Brunson, PRINCIPAL_INVESTIGATOR, Mann Eye Institute

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 Date2025-09-05
Study Completion Date2026-09-01

Study Record Updates

Study Start Date2025-09-05
Study Completion Date2026-09-01

Terms related to this study

Additional Relevant MeSH Terms

  • Myopia
  • Astigmatism