CONTOURA vs WFO Ablation PRK & LASIK

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

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.

Study Overview

• Status: Recruiting
• Conditions: Refractive Surgery
• Intervention / Treatment: Device: Wave-Front Optimized (WFO) ablation vs Topography-guided (TG) ablation

Detailed Description

In 2015, the FDA approved a new laser ablation profile for performing laser corneal refractive surgery. Multiple sophisticated profiles have been developed in an attempt to optimize visual outcomes and reduce post-operative lower and higher-order optical aberrations. Among these include wave-front optimized (WFO) and wave-front guided (WFG) ablation profiles. The former compensated for corneal curvature to reduce spherical aberration and the latter, a more complicated ablation profile, was designed to minimize specific aberrations in an individual eye. Topographic profiles have also been used for over 17 years. These profiles consider the shape of the anterior corneal surface. The newest such topographic ablation profile, Contoura Vision, is a topography guided (TG) profile that, based on over 22,000 curvature data points captured using the VARIO Topolyzer, individualizes the ablation pattern. For comparison, WFO uses a patient's estimated average corneal curvature alone to create an ablation pattern. The addition of the VARIO Topolyzer adds a significant increase of pre-operative patient preparation. Anecdotally, between 1-3hrs of additional technician hours are required to prepare a patient for the Contoura Vision TG ablation profile.

This will be a prospective randomized contralateral double-masked study. Patients will undergo the same standard of care preoperative evaluation and education as any other patient not enrolled in the study. The physician performing surgery will choose either LASIK or PRK, taking into account patient preference, preoperative data and overall clinical picture, ultimately choosing which is best for the patient. If a patient qualifies for both, the patient may choose either LASIK or PRK. Each patient will be randomized as to which eye undergoes a WFO treatment vs Contoura. At the time of surgery the 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 (measurement of visual acuity, refractions, transcription of PRO's) will be blinded as to which eye underwent Contoura vs WFO. While treatments will vary, both have the same safety profile. Both involve sophisticated lasers to change the shape of the cornea to achieve the desired outcome. The variance comes in the type of pattern the laser uses to treat each individual. All post-operative care will be standard of care with medications being the same as if the patient were not enrolled in the study. Post-operative evaluations will take place at postoperative day 1, week 1, month 1, month 3, and month 6.

All data collected will be standard pre- and post-operative ophthalmic refractive surgery measurements. This includes a standard medical history, especially to include prior eye surgeries or diseases. Pre-operative measurements include vision assessments, contrast sensitivity, pre- and post-dilation as well as keratometry and axial length measurements. The Contoura requires a separate set of data collection via the VARIO topolyzer. Intraoperative data collected will include variables such as actual treatment outcomes and laser settings. Post-operative measurements will consist of many of the same measurements as those obtained preoperatively including uncorrected and corrected visual acuity, and refractive measurements. A symptoms-based questionnaire specific to corrective eye surgery (PROWL) will be given to patients before and after surgery during routine follow-ups. Each PROWL is specific to an individual eye, not specific to the surgery performed in each eye (i.e. the same PROWL questionnaire will be used regardless of whether the patient underwent PRK or LASIK). All PROWL data will be compared pre- and post-operatively and will be stratified based on surgery.

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jose E Capo-Aponte, OD, PhD; Phone Number: 210-292-2554; Email: Jose.E.CapoAponte.ctr@health.mil
• Study Contact Backup: Name: AMBER MARTIN; Phone Number: 210-292-2483; Email: amber.l.martin38.ctr@Health.mil

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78236
      • Recruiting
      • Joint Warfighter Refractive Surgery Center at WHASC
      • Contact: Jose E Capo-Aponte, OD, PhD; Phone Number: 210-292-2554; Email: Jose.E.CapoAponte.ctr@health.mil
      • Contact: AMBER MARTIN; Phone Number: 210-292-2483; Email: amber.l.martin38.ctr@Health.mil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LASIK refractive surgery; Contralateral Randomize Wave-Front Optimized (WFO) ablation vs Topography-guided ablation	Device: 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
Experimental: PRK refractive surgery; Contralateral Randomize Wave-Front Optimized (WFO) ablation vs Topography-guided ablation	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative Uncorrected Visual Acuity	The Post-Operative visual acuity for eyes undergoing Wave-Front Optimized (WFO) ablation vs Topography-guided ablation	6 months post-surgery

Collaborators and Investigators

• Sponsor: 59th Medical Wing

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2021
• Primary Completion (Anticipated): April 30, 2023
• Study Completion (Anticipated): October 31, 2023

Study Registration Dates

• First Submitted: August 31, 2021
• First Submitted That Met QC Criteria: August 31, 2021
• First Posted (Actual): September 8, 2021

Study Record Updates

• Last Update Posted (Estimate): December 12, 2022
• Last Update Submitted That Met QC Criteria: December 8, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Topography guided ablation; Photorefractive Keratectomy (PRK); Laser-assisted in situ Keratomileusis (LASIK); Wave-Front Optimized (WFO)
• Other Study ID Numbers: FWH20200077H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No