Trial Outcomes & Findings for Clinical and Refractive Outcomes After Contoura® Refractive Surgery Planned Using Phorcides Surgery Planning Software (NCT NCT04495829)

NCT ID: NCT04495829

Last Updated: 2023-07-20

Results Overview

Residual refractive cylinder in diopters

• Recruitment status: COMPLETED
• Target enrollment: 70 participants
• Primary outcome timeframe: 3 months postop
• Results posted on: 2023-07-20

Participant Flow

Participant milestones

Measure	Phorcides 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 Study STARTED	70
Overall Study COMPLETED	65
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	Phorcides 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 Study Lost to Follow-up	2
Overall Study Inclusion criterion not met	3

Baseline Characteristics

Only subjects competing the 3-month visit were included

Baseline characteristics by cohort

Measure	Phorcides n=140 Eyes 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.
Age, Continuous	31 years STANDARD_DEVIATION 5.4 • n=65 Participants • Only subjects competing the 3-month visit were included
Sex: Female, Male Female	38 Participants n=65 Participants • Only subjects completing the 3-month visit are included
Sex: Female, Male Male	27 Participants n=65 Participants • Only subjects completing the 3-month visit are included
Region of Enrollment United States	70 participants n=70 Participants
MRSE	-3.6 diopters STANDARD_DEVIATION 1.79 • n=140 Eyes
Refractive cylinder	0.54 diopters STANDARD_DEVIATION .49 • n=140 Eyes
Uncorrected distance VA	.95 logMAR (log of min angle of resolution STANDARD_DEVIATION .33 • n=140 Eyes
Corrected distance VA	-.04 logMAR STANDARD_DEVIATION .04 • n=140 Eyes

PRIMARY outcome

Timeframe: 3 months postop

Residual refractive cylinder in diopters

Outcome measures

Measure	Phorcides n=130 Eyes 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.
Residual Refractive Cylinder	0.04 diopters Standard Deviation 0.09

SECONDARY outcome

Timeframe: 3 months postop

Uncorrected visual acuity at distance (4-6m)

Outcome measures

Measure	Phorcides n=130 Eyes 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.
Uncorrected Distance Visual Acuity	-.11 logMAR Standard Deviation 0.06

SECONDARY outcome

Timeframe: 3 months postop

Residual refractive spherical equivalent in diopters

Outcome measures

Measure	Phorcides n=130 Eyes 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.
Residual Refractive Sphere	0.08 diopters Standard Deviation 0.20

SECONDARY outcome

Timeframe: 3 months postop

A questionnaire related to visual quality and satisfaction after surgery

Outcome measures

Measure	Phorcides n=65 Participants 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.
Satisfaction and Vision Double vision · None to moderate	65 Participants
Satisfaction and Vision Double vision · Marked to severe	0 Participants
Satisfaction and Vision Trouble driving at night · None to moderate	65 Participants
Satisfaction and Vision Trouble driving at night · Marked to severe	0 Participants
Satisfaction and Vision Trouble reading · None to moderate	65 Participants
Satisfaction and Vision Trouble reading · Marked to severe	0 Participants
Satisfaction and Vision Dryness · None to moderate	63 Participants
Satisfaction and Vision Dryness · Marked to severe	2 Participants
Satisfaction and Vision Foreign body sensation · None to moderate	65 Participants
Satisfaction and Vision Foreign body sensation · Marked to severe	0 Participants
Satisfaction and Vision Fluctuation in vision · None to moderate	65 Participants
Satisfaction and Vision Fluctuation in vision · Marked to severe	0 Participants
Satisfaction and Vision Glare · None to moderate	65 Participants
Satisfaction and Vision Glare · Marked to severe	0 Participants
Satisfaction and Vision Halos · None to moderate	65 Participants
Satisfaction and Vision Halos · Marked to severe	0 Participants
Satisfaction and Vision Light sensitivity · None to moderate	63 Participants
Satisfaction and Vision Light sensitivity · Marked to severe	2 Participants
Satisfaction and Vision Pain · None to moderate	65 Participants
Satisfaction and Vision Pain · Marked to severe	0 Participants
Satisfaction and Vision Starbursts · None to moderate	65 Participants
Satisfaction and Vision Starbursts · Marked to severe	0 Participants

Adverse Events

Phorcides

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Phorcides n=70 participants at risk 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.
Eye disorders Epithelial defect	1.4% 1/70 • Number of events 1 • 3 months

Additional Information

R. Doyle Stulting, MD, PhD

Woolfson Eye Institute

Phone: (770) 255-3330

Email: dstulting@icloud.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place