Clinical and Refractive Outcomes After Contoura® Refractive Surgery Planned Using Phorcides Surgery Planning Software

NCT04495829 | Completed Results FDA Device

• 1 other identifier: ML-2020-01
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 5

Brief Summary

The objective of the current study is to prospectively evaluate 3-month clinical outcomes from LASIK performed using the Phorcides surgical planning software with Contoura topography-guided ablation in both eyes of subjects with myopia and myopic astigmatism seeking refractive surgery for distance correction.

Conditions

Refractive Errors

Outcome Measures

Primary Outcomes (1)

• Residual Refractive Cylinder

  Residual refractive cylinder in diopters

  3 months postop

Secondary Outcomes (3)

• Uncorrected Distance Visual Acuity

  3 months postop

• Residual Refractive Sphere

  3 months postop

• Satisfaction and Vision

  3 months postop

Study Arms (1)

Phorcides

Both eyes of subjects eligible for Contoura(R) topography-guided ablation with the Wavelight excimer laser, with surgery planned using Phorcides software.

Device: Phorcides Analytical Engine

Interventions

Phorcides Analytical Engine DEVICE

Surgery planning using the Phorcides analytical engine.

Also known as: Phorcides

Phorcides

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy subjects presenting for myopic LASIK correction who are eligible for treatment with topography-guided ablation in both eyes.

You may qualify if:

• Candidate for Contoura excimer laser vision correction
• Gender: males and females.
• Age: 20 or older
• Willing and able to provide written informed consent for participation in the study.
• Willing and able to comply with scheduled visits and other study procedures.
• Good ocular health, with no pathology that compromises visual acuity (other than refractive error)
• Corrected preoperative visual acuity of 20/20 (0.0 logMAR) or better in the eye being treated
• Meet Contoura eligibility requirements (approved range): up to -8.00 D sphere, up to -3.00 D cylinder, and a spherical equivalent no greater than -9.00 D
• Desire good vision at distance in both eyes

You may not qualify if:

• Corneal pathology (e.g. opacities, epithelial basement membrane dystrophy, Fuchs' dystrophy, etc.)
• Previous corneal surgery (e.g., radial keratotomy, corneal refractive surgery or corneal transplant, DSAEK, DMEK, lamellar keratoplasty)
• Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy)
• Desire for good uncorrected near vision in one or both eyes
• Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial
• Unsuitability for the trial, in the opinion of the investigator, for any reason
• Pregnancy or desire to become pregnant during the trial
• Intraoperative complications.

Sponsors & Collaborators

• American Corneal Consultants: lead
• Science in Vision: collaborator
• Alcon Research: collaborator

Study Sites (5)

Woolfson Eye Institute

Atlanta, Georgia, 30328, United States

Location

North Suburban Eye Specialists

Coon Rapids, Minnesota, 55433, United States

Location

TLC Laser Eye Center

Chesterfield, Missouri, 63017, United States

Location

Laser Defined Vision

Greensboro, North Carolina, 27401, United States

Location

Mann Eye Institute and Laser Centers

Houston, Texas, 77002, United States

Location

Related Publications (3)

• Stulting RD, Durrie DS, Potvin RJ, Linn SH, Krueger RR, Lobanoff MC, Moshirfar M, Motwani MV, Lindquist TP, Stonecipher KG. Topography-Guided Refractive Astigmatism Outcomes: Predictions Comparing Three Different Programming Methods. Clin Ophthalmol. 2020 Apr 24;14:1091-1100. doi: 10.2147/OPTH.S244079. eCollection 2020.

  PMID: 32425495 BACKGROUND

• Lobanoff M, Stonecipher K, Tooma T, Wexler S, Potvin R. Clinical outcomes after topography-guided LASIK: comparing results based on a new topography analysis algorithm with those based on manifest refraction. J Cataract Refract Surg. 2020 Jun;46(6):814-819. doi: 10.1097/j.jcrs.0000000000000176.

  PMID: 32176160 RESULT

• Stulting RD, Lobanoff M, Mann PM 2nd, Wexler S, Stonecipher K, Potvin R. Clinical and refractive outcomes after topography-guided refractive surgery planned using Phorcides surgery planning software. J Cataract Refract Surg. 2022 Sep 1;48(9):1010-1015. doi: 10.1097/j.jcrs.0000000000000910.

  PMID: 35171146 DERIVED

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: R. Doyle Stulting, MD, PhD
• Organization: Woolfson Eye Institute

dstulting@icloud.com

(770) 255-3330

Study Officials

• Robert D Stulting

  Woolfson Eye Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: August 3, 2020
• Study Start: July 24, 2020
• Primary Completion: April 21, 2021
• Study Completion: April 21, 2021
• Last Updated: July 20, 2023
• Results First Posted: April 14, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)