Comparison of outcomes of two types of surgical treatments for correction of high short sight
- 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
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- 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
Name Time Method 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
Name Time Method visual acuity, contrast sensitivity, aberrations, endothelial counts, spectacle independence, patient satisfactionTimepoint: post operative day 1, 15, 3 months, 6 months , 12 months