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

• Sponsor: American Corneal Consultants (Other)
• Overall Status: Completed
• CT.gov ID: NCT04495829
• Collaborator: Science in Vision (Other), Alcon Research (Industry)
• Enrollment: 70
• Locations: 5
• Actual Duration (Months): 8.9
• Patients Per Site: 14
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Refractive Errors	Device: Phorcides Analytical Engine

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 70 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Clinical and Refractive Outcomes After Contoura® Refractive Surgery Planned Using Phorcides Surgery Planning Software
• Actual Study Start Date: Jul 24, 2020
• Actual Primary Completion Date: Apr 21, 2021
• Actual Study Completion Date: Apr 21, 2021

Arms and Interventions

Arm	Intervention/Treatment
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; Surgery planning using the Phorcides analytical engine.; Other Names: Phorcides

Outcome Measures

Primary Outcome Measures

1. Residual Refractive Cylinder [3 months postop]

   Residual refractive cylinder in diopters

Secondary Outcome Measures

1. Uncorrected Distance Visual Acuity [3 months postop]

   Uncorrected visual acuity at distance (4-6m)

2. Residual Refractive Sphere [3 months postop]

   Residual refractive spherical equivalent in diopters

3. Satisfaction and Vision [3 months postop]

   A questionnaire related to visual quality and satisfaction after surgery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Woolfson Eye Institute	Atlanta	Georgia	United States	30328
2	North Suburban Eye Specialists	Coon Rapids	Minnesota	United States	55433
3	TLC Laser Eye Center	Chesterfield	Missouri	United States	63017
4	Laser Defined Vision	Greensboro	North Carolina	United States	27401
5	Mann Eye Institute and Laser Centers	Houston	Texas	United States	77002

Sponsors and Collaborators

• American Corneal Consultants
• Science in Vision
• Alcon Research

Investigators

• Principal Investigator: Robert D Stulting, Woolfson Eye Institute

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 15, 2020

More Information

Publications

• 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.

• Responsible Party: American Corneal Consultants
• ClinicalTrials.gov Identifier: NCT04495829
• Other Study ID Numbers: ML-2020-01
• First Posted: Aug 3, 2020
• Last Update Posted: Apr 14, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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.: Yes
• Additional relevant MeSH terms: Refractive Errors

Study Results

Participant Flow

Arm/Group Title	Phorcides
Arm/Group Description	Both eyes of subjects eligible for Contoura(R) topography-guided ablation with the Wavelight excimer laser, with surgery planned using Phorcides software. Phorcides Analytical Engine: Surgery planning using the Phorcides analytical engine.
Period Title: Overall Study
STARTED	70
COMPLETED	65
NOT COMPLETED	5

Baseline Characteristics

Arm/Group Title	Phorcides
Arm/Group Description	Both eyes of subjects eligible for Contoura(R) topography-guided ablation with the Wavelight excimer laser, with surgery planned using Phorcides software. Phorcides Analytical Engine: Surgery planning using the Phorcides analytical engine.
Overall Participants	70
Overall Eyes	140
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31 (5.4)
Sex: Female, Male (Count of Participants)
Female	38 54.3%
Male	27 38.6%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	70 100%
MRSE (diopters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [diopters]	-3.6 (1.79)
Refractive cylinder (diopters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [diopters]	0.54 (.49)
Uncorrected distance VA (logMAR (log of min angle of resolution) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [logMAR (log of min angle of resolution]	.95 (.33)
Corrected distance VA (logMAR) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [logMAR]	-.04 (.04)

Outcome Measures

1. Primary Outcome

Title	Residual Refractive Cylinder
Description	Residual refractive cylinder in diopters
Time Frame	3 months postop

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phorcides
Arm/Group Description	Both eyes of subjects eligible for Contoura(R) topography-guided ablation with the Wavelight excimer laser, with surgery planned using Phorcides software. Phorcides Analytical Engine: Surgery planning using the Phorcides analytical engine.
Measure Participants	65
Measure Eyes	130
Mean (Standard Deviation) [diopters]	0.04 (0.09)

2. Secondary Outcome

Title	Uncorrected Distance Visual Acuity
Description	Uncorrected visual acuity at distance (4-6m)
Time Frame	3 months postop

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phorcides
Arm/Group Description	Both eyes of subjects eligible for Contoura(R) topography-guided ablation with the Wavelight excimer laser, with surgery planned using Phorcides software. Phorcides Analytical Engine: Surgery planning using the Phorcides analytical engine.
Measure Participants	65
Measure Eyes	130
Mean (Standard Deviation) [logMAR]	-.11 (0.06)

3. Secondary Outcome

Title	Residual Refractive Sphere
Description	Residual refractive spherical equivalent in diopters
Time Frame	3 months postop

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phorcides
Arm/Group Description	Both eyes of subjects eligible for Contoura(R) topography-guided ablation with the Wavelight excimer laser, with surgery planned using Phorcides software. Phorcides Analytical Engine: Surgery planning using the Phorcides analytical engine.
Measure Participants	65
Measure Eyes	130
Mean (Standard Deviation) [diopters]	0.08 (0.20)

4. Secondary Outcome

Title	Satisfaction and Vision
Description	A questionnaire related to visual quality and satisfaction after surgery
Time Frame	3 months postop

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phorcides
Arm/Group Description	Both eyes of subjects eligible for Contoura(R) topography-guided ablation with the Wavelight excimer laser, with surgery planned using Phorcides software. Phorcides Analytical Engine: Surgery planning using the Phorcides analytical engine.
Measure Participants	65
None to moderate	65 92.9%
Marked to severe	0 0%
None to moderate	65 92.9%
Marked to severe	0 0%
None to moderate	65 92.9%
Marked to severe	0 0%
None to moderate	63 90%
Marked to severe	2 2.9%
None to moderate	65 92.9%
Marked to severe	0 0%
None to moderate	65 92.9%
Marked to severe	0 0%
None to moderate	65 92.9%
Marked to severe	0 0%
None to moderate	65 92.9%
Marked to severe	0 0%
None to moderate	63 90%
Marked to severe	2 2.9%
None to moderate	65 92.9%
Marked to severe	0 0%
None to moderate	65 92.9%
Marked to severe	0 0%

Adverse Events

Time Frame	3 months
Arm/Group Title	Phorcides
Arm/Group Description	Both eyes of subjects eligible for Contoura(R) topography-guided ablation with the Wavelight excimer laser, with surgery planned using Phorcides software. Phorcides Analytical Engine: Surgery planning using the Phorcides analytical engine.
All Cause Mortality
	Phorcides
	Affected / at Risk (%)	# Events
Total	0/70 (0%)
Serious Adverse Events
	Phorcides
	Affected / at Risk (%)	# Events
Total	0/70 (0%)
Other (Not Including Serious) Adverse Events
	Phorcides
	Affected / at Risk (%)	# Events
Total	1/70 (1.4%)
Eye disorders
Epithelial defect	1/70 (1.4%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.