N/A
N=114
VisuMax Femtosecond Laser Small Incision Lenticule Extraction for the Correction of High Myopia
Myopia · Refractive Errors
Bottom Line
View on ClinicalTrials.gov: NCT02528123 ↗Enrolled (actual)
114
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Variability of the Refractive Predicatibility — -0.22 Diopters
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Small incision lenticule extraction (Procedure); Tobramycin and dexamethasone (Drug); Ofloxacin (Drug); Proxymetacaine 0.5% (Drug); Oxybuprocaine 0.4% (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- London Vision Clinic
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Variability of the Refractive Predicatibility |
-0.22 | — |
| SECONDARY Efficacy of Uncorrected Distance Visual Acuity |
87 | — |
| SECONDARY Safety of Corrected Distance Visual Acuity (Change in Corrected Distance Visual Acuity) |
— | — |
| SECONDARY Predictability of Refractive Correction |
96 | — |
| SECONDARY Predictability of Refractive Astigmatism Correction |
93 | — |
| SECONDARY Stability of the Spherical Equivalent Refraction |
8 | — |
| SECONDARY Change in Night Vision Disturbances (Questionnaire) |
11 | — |
| SECONDARY Change in Corneal Higher Order Aberrations |
0.41 | — |
Summary
The purpose of this study is to validate the safety and effectiveness of treating myopia (short-sightedness) higher than -10D using small incision lenticule extraction (SMILE) with the VisuMax femtosecond laser.
Eligibility Criteria
Inclusion Criteria
Only patients who are medically suitable for corneal refractive surgery can be included in the study.
- Subjects should be 21 years of age or older
- Eyes with high myopia spherical equivalent between -9.00 D up to -14.00 D, with cylinder up to 7.00 D
- The corrected distance visual acuity will be 20/40 or better in each eye pre-operatively
- Calculated sub-lenticule thickness (SLT) ≥220 µm
- Calculated total uncut stromal thickness (TUST) ≥300 µm
- Contact lens wearers must stop wearing their contact lenses at least four weeks per decade of wear before baseline measurements in case of hard contact lenses and one week before baseline measurements in case of soft contact lenses.
- Patient will be able to understand the patient information and willing to sign an informed consent
- Patient will be willing to comply with all follow-up visits and the respective examinations as specified in the flow-chart
Exclusion Criteria
- Previous intraocular or corneal surgery of any kind on the eye being treated
- Patient not being able to lie flat in a horizontal position
- Patient not being able to tolerate local or topical anesthesia
- Autoimmune diseases
- Sicca syndrome, dry eye
- Herpes viral (herpes simplex) infections
- Herpes zoster
- Diabetes
- Pregnant or nursing women (or who are planning pregnancy during the study)
- Patients with a weight of > 135 kg
- Any residual, recurrent or acute ocular disease or abnormality of the eye, e.g.
- Cataract
- Suspected glaucoma or an intraocular pressure > 21 mm of Hg
- Corneal disease
- Corneal thinning disorder, e.g. keratoconus,
- Pellucid marginal corneal degeneration
- Dystrophy of the basal membrane
- Corneal oedema
- Exudative macular degeneration
- Infection
- Any residual, recurrent, or active abnormality of the cornea to be treated, e.g.
- Existing corneal implant
- Corneal lesion
- Unstable refraction
- Connective tissue disease
- Dry eye
Data sourced from ClinicalTrials.gov (NCT02528123). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.