Health Condition 1: H521- Myopia
Conditions
Interventions
Intervention1: Changing of Minimum Lenticule Thickness: treated with reduced min Lent Thicknesses with a specific energy (the other parameters are same as reference eye). Each procedure will take appr
Sponsors
Carl Zeiss Meditec AG
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients (male and female) should be 18 years of age or older 2.Normal corneal topography 3.Contact lens wearers must stop wearing their contact lenses at least 2 weeks before baseline measurements in case of hard contact lenses and 2 days before baselinemeasurements in case of soft contact lenses 4.Patients should be able to understand the patient information and willing to sign an informed consent. 5.Patients should be willing to comply with all follow-up visits and the respective examinations 6.Patients with myopia up to -10 D with or without astigmatism up to -5 D, 7.Similar refractive error in both eyes (within +/- 1.5 diopter of SEQ), 8. Patients should be targeted for emmetropia10, 9. patients should have a pre-operative CDVA of 20/25 or better in each eye,
Exclusion criteria
Exclusion criteria: 1.Patient not being able to lie flat in a horizontal position. 2.Patient not being able to tolerate local or topical anesthesia. 3.Autoimmune diseases 4.Sicca syndrome, Dry eye, graded as moderate to severe 5.Herpes viral (herpes simplex) infections 6.Herpes zoster 7.Diabetes 8.Pregnant or nursing women (or women, who planning pregnancy during the study) 9.Patients with a weight of > 135 kg 10.Treatment with systemic medication which influence wound healing, e.g.SteroidsAntimetabolites and Immunosuppressors 11.Treatment with medication with ocular side effects 12.Medication with the active substances:Isotretinoin (e.g. Accutane®),Amiodarone (e.g. Cordarone®) 13.Any residual, recurrent, or active disease of the eye to be treated, e.g. General infections 14.Disorders of the cornea like Corneal dystrophies,Dystrophy of basement membrane,Keratoconus,Pellucid marginal degeneration of the cornea,Other corneal deformities,Corneal edema,Corneal scars 15.Cataract 16.Age-related macular degeneration (exudative) 17.Presumed ocular histoplasmosis syndrome (POHS) 18.Glaucoma suspect (Intraocular pressure > 21 mm Hg) 19.Any residual, recurrent, or active abnormality of the eye to be treated, e.g.Existing corneal implant,Corneal lesion,Unstable refraction 21.Unstable central keratometry readings with irregularities 22.Connective tissue disease 23. Preoperative corneal thickness 24. Residual stromal thickness 25.Previous intraocular or corneal surgery of any kind on the eye being treated Exclusion criteria specific to the protocol 1. The patient may not participate in other ophthalmologic studies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ï?° For each group the difference between EXP and REF extraction score is to be determinedTimepoint: The time point for measurement will be immediately after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| ï?° Vision recovery at 1 day and 7 days ï?° Safety at day 90 ï?° Surgical safety ï?° Visual Quality at day 1, 7 and 90 Extraction time Timepoint: 1 day, 1 week, 1 month and 90 days | — |
Countries
India
Contacts
Public ContactDr Rupal Shah
New Vision Laser Centers Rajkot Pvt Ltd.
Outcome results
None listed