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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

A Comparison of safety and clinical outcomes of 100 vs 160µ cap in patients undergoing ReLEx-Small Incision Lenticule Extraction(SMILE).

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/09/005005
Enrollment
50
Registered
2014-09-10
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- REFRACTIVE ERROR IN BOTH EYES

Interventions

Intervention1: RELEX- SMALL INCISION LENTICULE EXTRACTION (SMILE): A Comparison of safety and clinical outcomes of 100 vs 160µ cap in patients undergoing ReLEx-Small Incision Lenticule Extraction(S

Sponsors

Nethradhama super speciality eye hospital
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
REFRACTIVE AND VISUAL OUTCOMESTimepoint: at 1 day post operatively, 15 days and 3 months post operatively

Secondary

MeasureTime frame
NOT APPLICABLETimepoint: NOT APPLICABLE

Countries

India

Contacts

Public ContactDR SHRI GANESH

NETHRADHAMA SUPER SPECIALITY EYE HOSPITAL

dr.savio.pereira@gmail.com09869921301

Outcome results

None listed

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