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Comparison of outcomes of two types of surgical treatments for correction of high short sight

Comparison of ReLEx SMILE and ICL in terms of visual outcomes and patient satisfaction for the correction of high myopia( 6 D ) - ReLEx ICL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/09/004969
Enrollment
60
Registered
2014-09-03
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 eyes besides myopia more than 6D

Interventions

Intervention1: ReLEx SMILE: 60 eyes of 30 patients satisfying the inclusion criteria, will be treated with ReLEx SMILE procedure which will be compared with the ICL group Control Intervention1: VISIA

Sponsors

Research Foundation Nethradhama Eye Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ReLEx SMILE group A: Inclusion criteria Any gender , 21 to 40 years of age Myopia between > -6 D and astigmatism upto â?? 0.5 Dcyl Stable corneal conditions within the last 12 months Stable refraction since past 12 months( Healthy ocular surface with stable tear film Discontinuation of Soft contact lenses 1 week , and rigid contact lenses 3 weeks prior to surgery ICL group B: Inclusion criteria: Any gender, 21 to 40 years of age ACD (endo) >= 3mm Myopia between > -6 D and astigmatism upto -0.5 D Stable corneal conditions within the last 12 months

Exclusion criteria

Exclusion criteria: Exclusion criteria- Group A â?? ReLEx SMILE Thin corneas ( Corneal pachymetry Steep corneas Kmax >48 D Keratoconus suspects or frank keratoconus Mixed astigmatism Moderate to severe dry eye(Shirmers1 Socket / globe /lid anomalies â?? very deep set eyes, nanophthalmos Severe meibomian gland disease, lid abnormalities Severe atopy Contact lens overuse Pregnant and nursing mother Pts on systemic medications eg Iso retinoic acid, hormonal preperations, OCPs, antidepressants Exclusion criteria: Age of less than 21 or more than 40 years. ACD (endo) Keratoconus Cataract or glaucoma Pregnant or nursing mothers Abnormal endothelial cell count Irido-corneal angles less than Grade III

Design outcomes

Secondary

MeasureTime frame
visual acuity, contrast sensitivity, aberrations, endothelial counts, spectacle independence, patient satisfactionTimepoint: post operative day 1, 15, 3 months, 6 months , 12 months—

Primary

MeasureTime frame
Matched population comparison of visual outcomes and patient satisfaction between two treatments modalities for the correction of high myopia6DTimepoint: post operative day 1, 15, 3 months, 6 months , 12 months—

Countries

India

Contacts

Public ContactDr Sri Ganesh

Nethradhama Superspeciality Eye Hospital

brar_sheetal@yahoo.co.in9591002092

Outcome results

None listed

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