MedPath

Comparison of two refractive surgery techniques ReLEx SMILE and PRK for the correction of low degrees of short sightedness

Phase 1
Conditions
Health Condition 1: null- Patients with low degrees of myopia (Spherical equivalent of -4D)
Registration Number
CTRI/2014/10/005084
Lead Sponsor
ETHRADHAMA SUPERSPECIALITY EYE HOSPITA
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
60
Inclusion Criteria

•Myopia with SEQ < - 4 D with cylinder upto - 2 D

•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

Exclusion Criteria

•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

•Autoimmune disorders

•Pts on systemic medications eg Iso retinoic acid, hormonal preperations, OCPs, antidepressants.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Matched population comparison of refractive and visual outcomes and patient satisfaction between ReLEx SMILE and PRK for the correction of low myopia (SEQ 4D)Timepoint: 6 months
Secondary Outcome Measures
NameTimeMethod
ot ApplicableTimepoint: Not Applicable
© Copyright 2025. All Rights Reserved by MedPath