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

Not Applicable
Conditions
Health Condition 1: null- healthy eyes besides myopia more than 6D
Registration Number
CTRI/2014/09/004969
Lead Sponsor
Research Foundation Nethradhama Eye Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
60
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( <0.5D change within 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:

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- Group A â?? ReLEx SMILE

Thin corneas ( Corneal pachymetry <480u)

Steep corneas Kmax >48 D

Keratoconus suspects or frank keratoconus

Mixed astigmatism

Moderate to severe dry eye(Shirmers1 <10 mm)

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

Age of less than 21 or more than 40 years.

ACD (endo) < 3 mm

Keratoconus

Cataract or glaucoma

Pregnant or nursing mothers

Abnormal endothelial cell count

Irido-corneal angles less than Grade III

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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
Secondary Outcome Measures
NameTimeMethod
visual acuity, contrast sensitivity, aberrations, endothelial counts, spectacle independence, patient satisfactionTimepoint: post operative day 1, 15, 3 months, 6 months , 12 months
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