RecruitingNot ApplicableNCT05037370

CONTOURA vs WFO Ablation PRK & LASIK

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


Sponsor

59th Medical Wing

Enrollment

400 participants

Start Date

Apr 22, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 21 YearsMax Age: 50 Years

Inclusion Criteria4

  • Meet requirements for PRK or LASIK i.e., Stable \<= .5 D change MRSE)
  • DOD beneficiaries age 21-50 years
  • Local pts (w/i 60 mi) who will be in the area for at least 6 months post surgery
  • Willing to complete all required follow-up visits

Exclusion Criteria11

  • No meeting requirements for PRK or LASIK
  • Desiring monovision treatment
  • Anisometropia \>2D spherical equivalent
  • Prior ocular surgeries / trauma / problem
  • History of dry eyes
  • Hyperopia
  • Mixed astigmatism
  • Inability to capture VARIO topolyzer scans
  • Pregnant (or who plans to be within 6 months after surgery)
  • Breastfeeding any time during the study
  • History of herpetic disease

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Interventions

DEVICEWave-Front Optimized (WFO) ablation vs Topography-guided (TG) ablation

Patient will undergo PRK or LASIK using WFO ablation in one eye and TG ablation on contralateral eye


Locations(1)

Joint Warfighter Refractive Surgery Center at WHASC

San Antonio, Texas, United States

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NCT05037370


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