Health Condition 1: H527- Unspecified disorder of refraction
Conditions
Interventions
Intervention1: Small incision lenticule extraction (SMILE) by the VisuMax femtosecond system: 1st eye ââ?¬â?? depth of SMILE cap 100 microns
2nd eye ââ?¬â?? depth of SMILE cap 150 microns
Control I
Sponsors
Carl Zeiss Meditec Inc
Eligibility
Inclusion criteria
Inclusion criteria: Patients undergoing refractive surgery SMILE
Exclusion criteria
Exclusion criteria: �Not suitable for refractive surgery due to abnormal topography or excess refractive error beyond recommended limit �Keratoconus or other corneal ectasia �Severe aqueous deficiency dry eye or other chronic ocular surface disorder �Corneal scarring or epitheliopathy �Active ocular infection �Previous ocular surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Observation of post operative visual outcomes, patient comfort, epithelial healing, biomechanics, corneal nerve and corneal collagen changes post SMILE surgery and analysis of the levels of tear biomarkers in subjects in the different treatment armsTimepoint: Pre Surgery, Surgery Visit, Post operative visit, 1 week, 1 month, 3 months and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| healing, biomechanics, corneal nerve and corneal collagen changes post SMILE surgery and analysis of the levels of tear biomarkers in subjects in the different treatment armsTimepoint: Preop, operative day, 1 week post op, 1 month post op, 3 months post op, 6 months op | — |
Countries
India
Contacts
Public ContactDr Sharon D Souza
Narayana Nethralaya
Outcome results
None listed