CTRI/2014/09/005061
Recruiting
Phase 1
A study of safety, efficacy and refractive outcomes of MEL 90 excimer laser platform - MEL 90
ETHRADHAMA SUPERSPECIALITY EYE HOSPITA0 sites100 target enrollmentTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Patients with Myopia, Hypermetropia and Astigmatism undergoing treatment on the MEL 90 excimer laser platform
- Sponsor
- ETHRADHAMA SUPERSPECIALITY EYE HOSPITA
- Enrollment
- 100
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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