Contoura With Phorcides Compared to Wavefront Optimized L... | NCT05486546

Studies
Contoura With Phorcides Compared to Wavefront Optimized LASIK

NCT05486546

Sponsor

Daniel Terveen

Status

Recruiting

Last Update Posted

Apr 26, 2023Actual

Enrollment

120Estimated

Phase

Not Applicable

Conditions

Myopia
Astigmatism

Interventions

Contoura with Phorcides
WaveLight Wavefront Optimized

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 15, 2022Actual

Primary Completion Date

Sep 1, 2023Estimated

Completion Date

Dec 1, 2023Estimated

First Submitted Date

Aug 1, 2022

First Submission Date that Met QC Criteria

Aug 1, 2022

First Posted Date

Aug 3, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 24, 2023

Last Update Posted Date

Apr 26, 2023Actual

Name	Class
Alcon Research	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study: Phorcides	Experimental	Contoura with Phorcides used for surgical planning of LASIK procedure	Procedure: Contoura with Phorcides
Control: Wavefront Optimized	Active Comparator	WaveLight Wavefront Optimized used for surgical planning of LASIK procedure	Device: WaveLight Wavefront Optimized

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Contoura with Phorcides	Procedure	Participants that undergo LASIK surgery using Contoura with Phorcides Analytic Engine	Study: Phorcides

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Post-Op UDVA	Percent of participants with monocular UDVA of 20/16 or better	3 months post-op

Secondary Outcomes

Measure	Description	Time Frame
Post-OP BCVA	Percent of participants with monocular and binocular BCVA of 20/16 or better	3 months post-op
Residual Refractive Error	Residual astigmatism and residual SE

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients at least age 21 years of age undergoing LASIK eye surgery
Willing and able to comprehend informed consent and complete 1 month post-op visit
Potential postoperative BCDVA of 20/20 or better in each eye based on Investigator's medical opinion
Candidates for Contoura with Phorcides (Myopic, astigmatism <3.0D)
Both eyes targeted for plano
Pre-operative total corneal Pachymetry 490um or above
Stable refractive error <0.50D change in preceding year
Good general and ocular health
Pre-operative exam completed within three months of surgery
SCL discontinued 3 days prior to pre-op exam and the procedure
Pachymetry above 490 with residual greater than 270um
Candidates who, as determined by the investigator, can safely undergo LASIK

Exclusion Criteria:

Patients under 21 years of age
Concomitant ocular condition which would limit the BCVA at the discretion of the surgeon
Patients with usual relative and absolute contraindications for LASIK surgery (Patients with severe dry eye, recurrent corneal erosion, uncontrolled Glaucoma, collagen vascular disorders, keratoconus or signs of keratoconus, uncontrolled Diabetes, Herpes)
Pachymetry below 490
Autoimmune or immunodeficiency diseases
Pregnant or nursing women
Patients with signs of inability to understand consent for study and procedure planned
Patients with history of previous ocular surgery
Patients with strabismus or amblyopia
Patients that have a BCDVA of 20/25 or worse in either eye

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

38 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Daniel Terveen, MD	Contact	605-645-7999		daniel.terveen@vancethompsonvision.com
Elise Meide, M.S.	Contact	605-645-0444		elise.reid@coyotes.usd.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vance Thompson Vison	Recruiting	Bozeman	Montana	57105	United States

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Sep 10, 2025			Sep 29, 2025	2
Oct 7, 2025

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases

ID	Term
D009216	Myopia
D001251	Astigmatism