CONTOURA vs WFO Ablation PRK & LASIK

NCT05037370 | Recruiting FDA Device

• 1 other identifier: FWH20200077H
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Post-operative refractive error

  The Post-Operative sphere equivalent refractive error for eyes undergoing Wave-Front Optimized (WFO) ablation vs Topography-guided ablation

  6 months post-surgery

Secondary Outcomes (1)

• Post-operative Uncorrected Visual Acuity

  6 months post-surgery

Study Arms (2)

LASIK refractive surgery

EXPERIMENTAL

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

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

PRK refractive surgery

EXPERIMENTAL

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

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

Interventions

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

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

LASIK refractive surgery; PRK refractive surgery

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• 59th Medical Wing: lead

Study Sites (1)

Joint Warfighter Refractive Surgery Center at WHASC

San Antonio, Texas, 78236, United States

RECRUITING

Study Officials

• CHARISMA B EVANGELISTA, MD

  59th Medical Wing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Patient will be blinded as to which eye receives which treatment, but the surgical team will not be blinded as to which procedure is performed. Post-operatively, the ophthalmic technicians and optometrists responsible for postoperative examinations will be blinded as to which eye underwent Contoura vs WFO.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Randomized contralateral double-masked study

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 8, 2021
• Study Start: April 22, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)