RECRUITING

CONTOURA vs WFO Ablation PRK & 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

This is a prospective randomized contralateral double-masked study. Each patient will be randomized as to which eye undergoes wave-front optimized (WFO) vs. wave-front guided (WFG) during Photorefractive keratectomy (PRK) or Laser-assisted in situ Keratomileusis (LASIK) surgery to determine which ablation profile provides the best visual outcome.

Official Title

Topography-guided vs. Wavefront Optimized Corneal Refractive Surgery: A Prospective Contralateral Randomized Double-masked Study

Quick Facts

Study Start:2021-04-22
Study Completion:2025-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05037370

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:21 Years to 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Meet requirements for PRK or LASIK i.e., Stable \<= .5 D change MRSE)
  2. * DOD beneficiaries age 21-50 years
  3. * Local pts (w/i 60 mi) who will be in the area for at least 6 months post surgery
  4. * Willing to complete all required follow-up visits
  1. * No meeting requirements for PRK or LASIK
  2. * Desiring monovision treatment
  3. * Anisometropia \>2D spherical equivalent
  4. * Prior ocular surgeries / trauma / problem
  5. * History of dry eyes
  6. * Hyperopia
  7. * Mixed astigmatism
  8. * Inability to capture VARIO topolyzer scans
  9. * Pregnant (or who plans to be within 6 months after surgery)
  10. * Breastfeeding any time during the study
  11. * History of herpetic disease

Contacts and Locations

Study Contact

JOSE E CAPO-APONTE, OD, PhD
CONTACT
210-292-2554
Jose.E.CapoAponte.ctr@health.mil
AMBER MARTIN
CONTACT
210-292-2483
amber.l.martin38.ctr@health.mil

Principal Investigator

CHARISMA B EVANGELISTA, MD
PRINCIPAL_INVESTIGATOR
59th Medical Wing

Study Locations (Sites)

Joint Warfighter Refractive Surgery Center at WHASC
San Antonio, Texas, 78236
United States

Collaborators and Investigators

Sponsor: 59th Medical Wing

  • CHARISMA B EVANGELISTA, MD, PRINCIPAL_INVESTIGATOR, 59th Medical Wing

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 Date2021-04-22
Study Completion Date2025-10-31

Study Record Updates

Study Start Date2021-04-22
Study Completion Date2025-10-31

Terms related to this study

Keywords Provided by Researchers

  • Photorefractive Keratectomy (PRK)
  • Laser-assisted in situ Keratomileusis (LASIK)
  • Wave-Front Optimized (WFO)
  • Topography guided ablation

Additional Relevant MeSH Terms

  • Refractive Surgery