MedPath

A study to see the surgical outcomes and how safe and effective is the new laser machine MEL 90

Phase 1
Conditions
Health Condition 1: null- Patients with Myopia, Hypermetropia and Astigmatism undergoing treatment on the MEL 90 excimer laser platform
Registration Number
CTRI/2014/09/005061
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
100
Inclusion Criteria

•Any gender, 21 to 40 years of age

•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

•For myopia correction, myopia upto -10 Diopters

•For hyperopia correction, hyperopia upto + 3 Diopters

•For astigmatic correction, astigmatism upto 3 Diopters

Exclusion Criteria

•Thin corneas (Corneal pachymetry <480u)

•Steep corneas Kmax >48 D

•Keratoconus suspects or frank keratoconus

•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
To evaluate the efficacy, safety and refractive outcomes of MEL 90 Excimer laser platform.Timepoint: 6 MONTHS
Secondary Outcome Measures
NameTimeMethod
OT APPLICABLETimepoint: NOT APPLICABLE
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