Health Condition 1: H522- Astigmatism Health Condition 2: O- Medical and Surgical Health Condition 3: H521- Myopia
Conditions
Interventions
Intervention1: Standard SMILE technique: Standard SMILE technique performed using standard laser settings
Control Intervention1: Different SMILE techniques: Different SMILE techniques performed using
Sponsors
Carl Zeiss Meditec AG
Eligibility
Inclusion criteria
Inclusion criteria: Patients who are medically suitable for SMILE are to be included if they additionally fulfilled the following specific inclusion criteria for this clinical investigation: 1. patients with myopia up to -10 D with or without astigmatism up to -5 D, similar refractive error in both eyes (within +/- 1.5 diopter of SEQ), 2. patients should be targeted for emmetropia, 3. 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. - Steroids - Antimetabolites 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 - Disorders of the cornea o Corneal dystrophies o Dystrophy of basement membrane o Keratoconus o Pellucid marginal degeneration of the cornea o Other corneal deformities o Corneal edema o Corneal scars - Cataract - Age-related macular degeneration (exudative) - Presumed ocular histoplasmosis syndrome (POHS) - Glaucoma suspect (Intraocular pressure > 21 mm Hg) -Any residual, recurrent, or active abnormality of the eye to be treated, e.g. - Existing corneal implant - Corneal lesion - Unstable refraction - Unstable central keratometry readings with irregularities - Connective tissue disease - Preoperative corneal thickness - Residual stromal thickness 14. Previous intraocular or corneal surgery of any kind on the eye being treated Exclusion criteria specific to the protocol 15. The patient may not participate in other ophthalmologic studies. 16.Any impaired person (minors, pregnant or breast feeding women or persons incapable of giving consent) are definitely excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Lenticule handling (tissue separation and extraction) in the experimental regime compared to the reference regime -The visual recovery based on the 1 day CDVA change from baseline is in the experimental regime compared to that of the reference regimeTimepoint: Intra-operative and Post-operative day 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Efficacy (defined as CDVApreOP-UDVApostOP) 2.Safety (defined as CDVApreOP-CDVApostOP) 3.Optical quality with OQAS device 4.Induced corneal aberrations 5.Contrast sensitivity 6.Cumulative UDVA 7.Cumulative CDVA 8.Change in CDVA 9.Refractive accuracy 10.Predictability of SE 11.Stability of SE 12.Refractive astigmatism 13.Intraoperative complications 14.Adverse events 15.Patient questionnaire on patient satisfactionTimepoint: Post-operative day 1, 1 week, 1 month ans 3 months | — |
Countries
India
Contacts
Public ContactDr Sri Ganesh
Nethradhama Superspeciality Eye Hospital
Outcome results
None listed