Comparative study to evaluate the effect of different SMILE cap depth in post operative healing
Not Applicable
- Conditions
- Health Condition 1: H527- Unspecified disorder of refraction
- Registration Number
- CTRI/2021/03/032259
- Lead Sponsor
- Carl Zeiss Meditec Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patients undergoing refractive surgery SMILE
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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