Patient Reported Satisfaction With Contoura LASIK Utilizing the Phorcides Analytic Software

Myopia Clinical Trial

Official title:

Patient Reported Satisfaction With Contoura LASIK Utilizing the Phorcides Analytic Software

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05848817
• Other study ID #: PB-23-01
• Status: Recruiting
• Start date: May 19, 2023
• Est. completion date: May 15, 2024

Study information

• Verified date: June 2023
• Source: Mann Eye Institute
• Contact: Melissa Hamann Wright
• Phone: 713-580-2500
• Email: Melissa.Wright[@]manneye.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: May 15, 2024
• Est. primary completion date: May 15, 2024
• Gender: All
• Age group: 21 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Contoura LASIK
Subjects receiving Phorcides Planned Contoura LASIK

Locations

Country	Name	City	State
United States	Mann Eye Institute	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Mann Eye Institute	Sengi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Higher order aberrations	Preoperative and postoperative higher order aberrations (spherical aberration and coma).	3 Months Postoperative
Other	PROWL Questionnaire	PROWL-SS can be used to assess satisfaction with vision and the existence, bothersomeness and impact on usual activities in the last 7 days of four visual symptoms - double images (8 items), glare (8 items), halos (8 items) and starbursts (8 items). Subjects select one of 6 responses for each question.	3 Months Postoperative
Other	OSDI Score	The OSDI© is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease. The OSDI© is a valid and reliable instrument for measuring dry eye disease (normal, mild to moderate, and severe) and effect on vision-related function.	3 Months Postoperative
Other	Correlation of OSDI Score to subject reported satisfaction		3 Months Postoperative
Primary	Subject Satisfaction	Percentage of subjects satisfied with vision after Phorcides Planned Contoura LASIK (answering Completely Satisfied or Very Satisfied on PROWL Questionnaire Question #1.	3 Months Postoperative
Secondary	Percentage of eyes with post-op spherical equivalent within +/- 0.50 D		3 Months Postoperative