Patient Reported Satisfaction With Contoura LASIK Utilizing the Phorcides Analytic Software

NCT ID: NCT05848817

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-19
• Study Completion Date: 2024-08-15

Brief Summary

The objective is to determine the percentage of subjects satisfied (Completely Satisfied or Very Satisfied) with vision after Phorcides Planned Contoura LASIK.

Detailed Description

This study is a single site, single-arm, prospective, observational study of subject satisfaction, after successful bilateral LASIK surgery. Subjects will be assessed pre-operatively, operatively and at 1 week, 1 month, and 3 months post-operatively. Clinical evaluations will include measurement of visual acuity, manifest refraction, and topography, aberrometry, and administration of the OSDI and PROWL questionnaires.

Conditions

Myopia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Contoura LASIK

Subjects receiving Phorcides Planned Contoura LASIK.

Contoura LASIK

Intervention Type: DEVICE

Subjects receiving Phorcides Planned Contoura LASIK

Interventions

Contoura LASIK

Subjects receiving Phorcides Planned Contoura LASIK

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Note: Ocular criteria must be met in both eyes.

• Appropriate candidate for uncomplicated bilateral LASIK surgery
• Gender: Males and Females.
• Age: 21 to 39 years of age.
• Refractive error range - SE refractive errors up to 0.00 to -9.00 D with maximum cylinder up to 3.00 D and sphere ≤ -8.00 D.
• If currently wearing contact lenses:

• Soft CTL wearers discontinue for minimum 3 days
• RGP CTL wearers discontinue for 1 month per decade of wear
• Stable refraction (2 consecutive manifest refractions within 0.25 SE)
• Stable K readings (2 consecutive K readings in 2 consecutive visits)
• Residual bed thickness 250um or greater
• Willing and able to comply with scheduled visits and other study procedures.
• Pre-surgery BCDVA of 20/20 (0.00 logMAR) or better in each eye.

Exclusion Criteria

• Subjects with history of previous ocular surgery.
• Subjects with topographic evidence of keratoconus, or ectasia.
• Subjects with autoimmune diseases.
• Subjects who are pregnant or nursing.
• Systemic disease likely to affect wound healing, such as diabetes and severe atopy.
• Any ocular disease (including un-controlled dry eye) which in the investigator's opinion would affect the outcome of refractive surgery.

The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.

Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sengi

INDUSTRY

Sponsor Role: collaborator

Mann Eye Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Phillip Brunson, OD

Role: PRINCIPAL_INVESTIGATOR

Mann Eye Institute

Locations

Mann Eye Institute

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PB-23-01

Identifier Type: -

Identifier Source: org_study_id