Clinical trial NCT04495829: Clinical and Refractive Outcomes After Contoura® Refractive Surgery Planned Using Phorcides Surgery Planning Software
Official title: Clinical and Refractive Outcomes After Contoura® Refractive Surgery Planned Using Phorcides Surgery Planning Software
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Refractive Errors
Lead sponsor: American Corneal Consultants
Sponsor class: OTHER
Collaborators: name: Science in Vision
name: Alcon Research
First posted: 2020-08-03
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Residual Refractive Cylinder
timeFrame: 3 months postop
Secondary outcomes:
measure: Uncorrected Distance Visual Acuity
timeFrame: 3 months postop
measure: Residual Refractive Sphere
timeFrame: 3 months postop
measure: Satisfaction and Vision
timeFrame: 3 months postop
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Woolfson Eye Institute
state: Georgia
city: Coon Rapids
country: United States
facility: North Suburban Eye Specialists
state: Minnesota
city: Chesterfield
country: United States
facility: TLC Laser Eye Center
state: Missouri
city: Greensboro
country: United States
facility: Laser Defined Vision
state: North Carolina
city: Houston
country: United States
facility: Mann Eye Institute and Laser Centers
state: Texas
Study officials:
affiliation: Woolfson Eye Institute
name: Robert D Stulting
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: 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.