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A comparison of safety and clinical outcomes of refractive surgery - Relex Smile, when 100 microns depth cornea is cut to remove tissue of if at 160 microns cornea is cut to remove tissue

Not Applicable
Conditions
Health Condition 1: null- REFRACTIVE ERROR IN BOTH EYES
Registration Number
CTRI/2014/09/005005
Lead Sponsor
ethradhama super speciality eye hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
50
Inclusion Criteria

1.Above 21 years& below 40 years.

2.Spherical equivalent from -1 to â??10.00 D and Cylinder upto-5.00 D.

3.Stable refraction at least for the previous 1 year.

4.Soft Contact lenses will have to be discontinued for minimum 1 week and rigid gas permeable contact lens discontinued for minimum 3 weeks before the baseline measurement.

Exclusion Criteria

1.Age less than 21 years and more than 40 years.

2.Evidence of lid diseases like meibomian gland dysfunction.

3.Anterior segment pathologies of the cornea like corneal dystrophy, corneal scars, keratitis, topographic evidence of keratoconus. Residual, recurrent or active ocular disease such as uveitis, severe dry eyes, severe allergic eye disease, glaucoma, visually significant cataract.

4.Retinal pathologies like diabetic retinopathy and retinal dystrophies.

5.Progressive or unstable myopia and/or irregular astigmatism.

6.Previous intraocular or corneal surgery.

7.Ocular medications being used like antiglaucoma medications.

8.Systemically immunocompromised.

9.Pregnant or nursing women.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
REFRACTIVE AND VISUAL OUTCOMESTimepoint: at 1 day post operatively, 15 days and 3 months post operatively
Secondary Outcome Measures
NameTimeMethod
OT APPLICABLETimepoint: NOT APPLICABLE
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