Contoura With Phorcides Compared to Wavefront Optimized LASIK

NCT ID: NCT05486546

Last Updated: 2023-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-15

Study Completion Date

2023-12-01

Brief Summary

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Comparing post-operative visual acuity and patient reported satisfaction between Contoura with Phorcides and WaveLight Wavefront Optimized.

Detailed Description

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Conditions

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Myopia Astigmatism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Study: Phorcides

Contoura with Phorcides used for surgical planning of LASIK procedure

Group Type EXPERIMENTAL

Contoura with Phorcides

Intervention Type PROCEDURE

Participants that undergo LASIK surgery using Contoura with Phorcides Analytic Engine

Control: Wavefront Optimized

WaveLight Wavefront Optimized used for surgical planning of LASIK procedure

Group Type ACTIVE_COMPARATOR

WaveLight Wavefront Optimized

Intervention Type DEVICE

Participants that undergo LASIK surgery using WaveLight Wavefront Optimized

Interventions

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Contoura with Phorcides

Participants that undergo LASIK surgery using Contoura with Phorcides Analytic Engine

Intervention Type PROCEDURE

WaveLight Wavefront Optimized

Participants that undergo LASIK surgery using WaveLight Wavefront Optimized

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

38 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role collaborator

Daniel Terveen

OTHER

Sponsor Role lead

Responsible Party

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Daniel Terveen

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Vance Thompson Vison

Bozeman, Montana, United States

Site Status RECRUITING

Vance Thompson Vision

Omaha, Nebraska, United States

Site Status RECRUITING

Vance Thompson Vision

Fargo, North Dakota, United States

Site Status RECRUITING

Vance Thompson Vision

Sioux Falls, South Dakota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Daniel Terveen, MD

Role: CONTACT

605-645-7999

Elise Meide, M.S.

Role: CONTACT

605-645-0444

Facility Contacts

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Keeley Boever

Role: primary

402-740-9420

Keeley Boever

Role: primary

402-740-9420

Keeley Boever

Role: primary

402-740-9420

Keeley Puls

Role: primary

605-371-7075

Other Identifiers

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AMPLIO

Identifier Type: -

Identifier Source: org_study_id

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