Mann Eye Institute
Houston, Texas, 76134-2099, United States
NCT Number: NCT05848817
The objective is to determine the percentage of subjects satisfied (Completely Satisfied or Very Satisfied) with vision after Phorcides Planned Contoura LASIK.
Looking for future studies?
Notify Me21 year–39 year
All sexes
Observational
Houston, Texas, 76134-2099, United States
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.
Only the study team can determine whether someone qualifies for participation.
Subjects are eligible for the study if they meet the following criteria:
Note: Ocular criteria must be met in both eyes.
If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
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.
Subjects receiving Phorcides Planned Contoura LASIK
Time frame: 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.
Time frame: 3 Months Postoperative
Time frame: 3 Months Postoperative
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. Responses are scaled from 0 to 100, with 0 being a worse overall outcome and 100 being a better overall outcome for 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).
Time frame: 3 Months Postoperative
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.
Mann Eye Institute
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03334253
Eye Diseases, Myopia
Birmingham, Alabama, United States
View Trial DetailsNCT07087665
Eye Diseases, Myopia
Saint Louis Park, Minnesota, United States
View Trial DetailsNCT06700460
Eye Diseases, Myopia
Omaha, Nebraska, United States
View Trial DetailsNCT00320593
Eye Diseases, Myopia
Birmingham, Alabama, United States
View Trial Details