Clinical trial NCT05848817: Patient Reported Satisfaction With Contoura LASIK Utilizing the Phorcides Analytic Software
Official title: Patient Reported Satisfaction With Contoura LASIK Utilizing the Phorcides Analytic Software
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myopia
Lead sponsor: Mann Eye Institute
Sponsor class: OTHER
Collaborators: name: Sengi
First posted: 2023-05-08
Enrollment: 5
Sex: ALL
Minimum age (years): 21
Maximum age (years): 39
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects 21 to 39 years of who are appropriate candidates for laser refractive surgery.

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.

Eligibility criteria: Subjects are eligible for the study if they meet the following 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.

If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.

* 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.

Primary outcomes:
measure: Subject Satisfaction
timeFrame: 3 Months Postoperative
Secondary outcomes:
measure: Percentage of eyes with post-op spherical equivalent within +/- 0.50 D
timeFrame: 3 Months Postoperative
Other outcomes:
measure: Higher order aberrations
timeFrame: 3 Months Postoperative
measure: PROWL Questionnaire
timeFrame: 3 Months Postoperative
measure: OSDI Score
timeFrame: 3 Months Postoperative
measure: Correlation of OSDI Score to subject reported satisfaction
timeFrame: 3 Months Postoperative
Locations:
city: Houston
country: United States
facility: Mann Eye Institute
state: Texas
Study officials:
affiliation: Mann Eye Institute
name: Phillip Brunson, OD
role: PRINCIPAL_INVESTIGATOR
References: