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

COMPARISON OF CORNEAL SURFACE FLATTENING BETWEEN RELEX SMILE AND FEMTOSECOND LASIK IN RELATION TO OPTICAL ZONE

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/09/005026
Enrollment
100
Registered
2014-09-16
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- HEALTHY PATIENTS WITH SHORT SIGHTEDNESS

Interventions

Intervention1: LASIK- LASER ASSISTED IN SITU KERATOMILEUSIS, SMILE- SMALL INCISION LENTICULE EXTRACTION: Visual parameters: 1. UCVA 2. BCVA 3. Manifest refraction:-Magnitude of Sphere(D), Magnitudeof

Sponsors

NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL
Lead Sponsor

Eligibility

Inclusion criteria

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: 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.

Design outcomes

Primary

MeasureTime frame
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—

Secondary

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

Countries

India

Contacts

Public ContactDR SRI GANESH

NETHRADHAMA SUPER SPECIALITY EYE HOSPITAL

phacomaverick@gmail.com9845129740

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026