Recruiting

CONTOURA vs. WFO

Sponsor:

59th Medical Wing

Code:

NCT05037370

Conditions

Refractive Surgery

Eligibility Criteria

Sex: All

Age: 21 - 50

Healthy Volunteers: Accepted

Interventions

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

Study Details

Brief 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.

Conditions

Refractive Surgery

Study ID

NCT05037370

Start date

Apr 22, 2021

Status verified date

Aug, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 50

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: LASIK refractive surgery

Contralateral Randomize Wave-Front Optimized (WFO) ablation vs Topography-guided ablation

experimental: PRK refractive surgery

Contralateral Randomize Wave-Front Optimized (WFO) ablation vs Topography-guided ablation

Interventions

Wave-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

Primary outcome measure

  • Post-operative refractive error [ Time Frame: 6 months post-surgery ]

Central Contacts and Locations

Central contacts

JOSE E CAPO-APONTE, OD, PhD

210-292-2554Jose.E.CapoAponte.ctr@health.mil

AMBER MARTIN

210-292-2483amber.l.martin38.ctr@health.mil

Locations

Joint Warfighter Refractive Surgery Center at WHASC

Recruiting

San Antonio, Texas, United States, 78236

Contacts

JOSE E CAPO-APONTE, OD, PhD

210-292-2554jose.e.capoaponte.ctr@health.mil

AMBER MARTIN

210-292-2483amber.l.martin38.ctr@Health.mil

More Information

Sponsor

59th Medical Wing

Last update posted

Aug 14, 2025

Last verified

Aug, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by 59th Medical Wing on 2025-08-14.