Patient Reported Satisfaction With Contoura LASIK Utilizing the Phorcides Analytic Software

Completed

• Conditions: Myopia
• Interventions: Device: Contoura LASIK

• Registration Number: NCT05848817
• Lead Sponsor: Mann Eye Institute

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.

Study Timeline

• Study First Submitted: 2023-04-28
• Study First Submitted QC: 2023-04-28
• Study First Posted: 2023-05-08
• Study Start: 2023-05-19
• Primary Completion: 2024-08-15
• Study Completion: 2024-08-15
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Contoura LASIK	Contoura LASIK	Subjects receiving Phorcides Planned Contoura LASIK.

Primary Outcome Measures

Name	Time	Method
Subject Satisfaction	3 Months Postoperative	Percentage of subjects satisfied with vision after Phorcides Planned Contoura LASIK (answering Completely Satisfied or Very Satisfied on PROWL Questionnaire Question #1.

Secondary Outcome Measures

Name	Time	Method
Percentage of eyes with post-op spherical equivalent within +/- 0.50 D	3 Months Postoperative

Trial Locations

Locations (1)

Mann Eye Institute; 🇺🇸 Houston, Texas, United States