VisuMax Femtosecond Laser Small Incision Lenticule Extraction for the Correction of High Myopia

• Status: Active, not recruiting
• Trial end date: 2020-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: London Vision Clinic
• Treatments: Anesthetics; BB 1101; Benoxinate; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Levofloxacin; Ofloxacin; Procaine; Propoxycaine; Proxymetacaine; Tobramycin

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