Health Condition 1: null- patients with healthy eyes besides low to moderate myopic astigmatism
Conditions
Interventions
Intervention1: ICL (V4C) MODEL: ICL (V4C) MODEL implantation in suitable patients satisfying inclusion criteria
Control Intervention1: FEMTO LASIK: FEMTO LASIK procedure will be performed in suitabl
Sponsors
Nethradhama Research Foundation
Eligibility
Inclusion criteria
Inclusion criteria: ICL group A: Inclusion criteria: Any gender, 21 to 45 years of age ACD (endo) >= 3mm Myopia between -3 to -8 D and astigmatism between upto -3D Stable corneal conditions within the last 12 months FEMTO-LASIK group B: Inclusion criteria Any gender between 21 to 45 years of age Myopia between -3 to -8 D and astigmatism upto - 3 Dcyl Stable corneal conditions within the last 12 months Stable refraction since 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 SMILE group C: Inclusion criteria Any gender , 21 to 45 years of age Myopia between -3 to -8 D and astigmatism upto - 3 Dcyl Stable corneal conditions within the last 12 months Stable refraction since 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
Exclusion criteria: Exclusion criteria: Age of less than 21 or more than 45 years. ACD (endo) Myopia outside -3 to -8 D range or astigmatism > 3 D Keratoconus Cataract or glaucoma Pregnant or nursing mothers Abnormal endothelial cell count Irido-corneal angles less than Grade III Exclusion criteria- applicable to both F-LASIK and SMILE groups Myopia > -8 D SE and Manifest cylinder > 5D Thin corneas ( Corneal pachymetry Steep corneas Kmax >48 D Keratoconus suspects o r frank keratoconus Mixed astigmatism Moderate to severe dry eye(Shirmers1 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy, predictability, stability and safety variables (efficacy and safety indexes) and stability over-time Timepoint: post op day 1, day 15, 3 months, 6 months, 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of contrast sensitivity Aberrations Subjective assessment of visual disturbances, patient satisfaction and spectacle independence Dry eye symptoms Timepoint: post op day 1, day 15, 3 months, 6 months, 12 months | — |
Countries
India
Contacts
Public ContactDr Sri Ganesh
Nethradhama Superspeciality Eye Hospital
Outcome results
None listed