MedDRA - 10038268 - Brechkraftstörung
Conditions
Interventions
Group 1: Corneal refractive laser surgery using small incision lenticule extraction combined with micro-anisometropia using the VisuMax femtosecond laser system.
Sponsors
Carl Zeiss Meditec AG
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: - Presence of myopia with or without astigmatism in both eyes with a need for laser set correction from -1.00 D up to -10.00 D sphere, cylinder up to 5.00 D, and spherical equivalent from -1.00 D up to -12.50 D - Patient age of 40 years or older - Presence of presbyopia - Preoperative CDVA of 20/25 or better in each eye - Ability and agreement to comply with follow-up visits and examinations
Exclusion criteria
Exclusion criteria: - Presence of at least one of the contraindications stated in the User Manual of the VisuMax option SMILE. This includes patients for whom lens extraction is the preferred alternative treatment. - Emmetropic refraction, defined as spherical equivalent refraction < -1.00 D in one or both eyes - Participation in other medical or pharmaceutical studies - Women during pregnancy and/or lactation or women who are planning to get pregnant - Patients whose freedom is impaired by administrative or legal order - Person is incapable of giving consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of eyes with loss of 2 lines (10 letters) or more of corrected distance visual acuity at 3 months postoperative compared to the baseline visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of eyes intended for emmetropia achieving uncorrected distance visual acuity of 20/40 or better at 3 months postoperatively | — |
Countries
Austria, Czechia, Denmark, Germany, Poland, Switzerland
Contacts
Public ContactWalter Sekundo
Klinik für AugenheilkundeUniversitätsklinikum Gießen und MarburgGmbH, Standort Marburg
Outcome results
None listed