Myopia
Conditions
Brief summary
This study is a single-site, single-arm, prospective, observational study of subject satisfaction, quality of vision, and quality of life after bilateral LASIK surgery. Subjects will be assessed 6 months post-operatively. Clinical evaluations will include refractive outcomes, visual acuity, and administration of the adapted PROWL, QIRC, and OSDI questionnaires.
Interventions
DEVICEWavelight Plus
The WaveLight EX500 laser system, in conjunction with INNOVEYES Sightmap, is indicated for use in INNOVEYES Laser Assisted In-Situ Keratomileusis ("wavelight plus"1 LASIK) treatments: * or the reduction or elimination of myopia or myopia with astigmatism, in eyes with spherical equivalent (SE) more than -1.00 and up to -9.00 diopters (D), with up to -8.00 D of spherical component (in minus cylinder format) and up to -3.00 D of astigmatic component at the spectacle plane, based on the INNOVEYES Sightmap Measured Refraction, * in patients with magnitude of the spherical equivalent (SE) difference between the Manifest Refraction (MRSE) and the Sightmap measured refraction SE being less than 0.75D, * in patients who are 18 years of age or older, and * for patients with documentation of a stable manifest refraction defined as 0.5 D preoperative spherical equivalent shift over one year prior to surgery.
Sponsors
OVO LASIK + Lens
Sengi
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 37 Years
Healthy volunteers
No
Inclusion criteria
* Subject must be able to understand and sign an approved consent form. * Willing and able to comply with scheduled visits and other study procedures. * Age: 18 to 37 * Myopia with or without astigmatism and MRSE within the range indications for wavelight plus (myopia up to -8 D, astigmatism up to -3.0 D, S.E. more than -1.00 and up to -9.00D) * Pre-surgery BCDVA of 20/20 (0.00 logMAR) or better in each eye. * Stable refraction (within ± 0.50 D) as determined by manifest refraction spherical equivalent for a minimum of 12 months prior to surgery. * Refractive target of bilateral emmetropia * Mesopic pupil size ≥ 4.5mm * Less than 0.75 D spherical equivalent difference between Sightmap measured refraction SE and the subjective manifest refraction (MRSE)
Exclusion criteria
* Subjects with a history of previous ocular surgery. * Subjects with topographic evidence of keratoconus or ectasia. * Pre-existing retinal or corneal pathology 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 uncontrolled dry eye) in which the investigator's opinion would affect the outcome of refractive surgery. * Patients with a calculated residual stromal depth \<250 µm would be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects satisfied (Completely Satisfied or Very Satisfied) with vision after Wavelight Plus LASIK based on an adapted PROWL Questionnaire (Question #1 only). | 6 months postoperatively |
Secondary
| Measure | Time frame |
|---|---|
| Remaining Vision quality and quality of life during daily tasks using the adapted PROWL | 6 months postoperatively |
| The percentage of eyes at each monocular visual acuity (VA) level (uncorrected 20/10, 20/12.5, 20/16, 20/20, 20/25). | 6 months postoperatively |
| The percentage of subjects at each binocular visual acuity (VA) level (uncorrected 20/10, 20/12.5, 20/16, 20/20, 20/25). | 6 months postoperatively |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMark C Lobanoff, MD
OVO LASIK + Lens
Outcome results
None listed