Study for comparison between two types of refractive surgeries(for spectacle removal) one involvingcreating a flap in cornea(black part of eye)-lasik and one without a flap- ReLEx SmILE

Not Applicable

• Conditions: Health Condition 1: null- HEALTHY PATIENTS WITH SHORT SIGHTEDNESS

• Registration Number: CTRI/2014/09/005026
• Lead Sponsor: ETHRADHAMA SUPERSPECIALITY EYE HOSPITA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

1.Age above 18 years and less than 40 years.

2.Myopia between -3D to -8D spherical equivalent/amount of

astigmatism less than -1D

3.Stable refraction for at least 6months- 1 year

4.Soft contact lens discontinued for minimum 1 week and rigid gas

permeable contact lens discontinued for minimum 3 weeks before

the baseline measurement.

5.Corneal topography â?? minimum corneal thickness 480µ, residual

corneal thickness at least 250µ/50% of original thickness

whichever is higher.

Exclusion Criteria

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, and topographic evidence of

keratoconus.

4.Residual, recurrent or active ocular disease such assevere dry

eyes, severe allergic eye disease, uveitis, glaucoma, visually

significant cataract.

5.Retinal pathologies like diabetic retinopathy and retinal

dystrophies.

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

7.Previous intraocular or corneal surgery.

8.Ocular medications being used like anti-glaucoma medications

and systemic medication likely to affect wound healing like

corticosteroids or anti-metabolites.

9.Systemically immune-compromised individuals.

10.Pregnant or nursing women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SMILE has a lower induction rate of higher-order aberrations and spherical aberration than the FS-LASIK procedure. The topographic optical zone was reduced from the programmed ablation zone in SMILE compared to LASIK.Timepoint: DAY 1,15,90, 180 <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
The topographic optical zone was reduced from the programmed ablation zone in SMILE compared to LASIK.Timepoint: DAY 1, 15, 90, 180