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

Refractive Errors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04495829
• Other study ID #: ML-2020-01
• Status: Completed
• Start date: July 24, 2020
• Est. completion date: April 21, 2021

Study information

• Verified date: February 2022
• Source: American Corneal Consultants
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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. Data will be compared to published results for wavefront optimized LASIK and LASIK performed with Contoura using other refractive algorithms.

The hypothesis is that use of the Phorcides planning software will result in a higher percentage of eyes with residual refractive cylinder ≤ 0.25D than will be achieved with wavefront-optimized (WFO) LASIK. It is also expected that unaided postoperative visual acuity and visual symptoms will be improved.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 21, 2021
• Est. primary completion date: April 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Refractive Errors

Intervention

Device:
• Phorcides Analytical Engine
Surgery planning using the Phorcides analytical engine.

Locations

Country	Name	City	State
United States	Woolfson Eye Institute	Atlanta	Georgia
United States	TLC Laser Eye Center	Chesterfield	Missouri
United States	North Suburban Eye Specialists	Coon Rapids	Minnesota
United States	Laser Defined Vision	Greensboro	North Carolina
United States	Mann Eye Institute and Laser Centers	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
American Corneal Consultants	Alcon Research, Science in Vision

Country where clinical trial is conducted

United States, 

References & Publications (2)

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):814-81 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Residual Refractive Cylinder	Residual refractive cylinder in diopters	3 months postop
Secondary	Uncorrected Distance Visual Acuity	Uncorrected visual acuity at distance (4-6m)	3 months postop
Secondary	Residual Refractive Sphere	Residual refractive spherical equivalent in diopters	3 months postop
Secondary	Satisfaction and Vision	A questionnaire related to visual quality and satisfaction after surgery	3 months postop