Study for comparison between two types of refractive surgeries(for spectacle removal) one involving creating a flap in cornea(black part of eye)-lasik and one without a flap- ReLEx SmILE
- Conditions
- Health Condition 1: null- Healthy Patients with Short Sightedness
- Registration Number
- CTRI/2014/09/005040
- Lead Sponsor
- ethradhama Superspeciality Eye Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 100
•SINGLE SURGEON
•MYOPIA BETWEEN 1D TO 10D SPHERICAL EQUIVALENT/AMOUNT OF ASTIGMATISM LESS THAN 5D
•AGE ABOVE 21 YEARS AND LESS THAN 40 YEARS.
•STABLE REFRACTION FOR ATLEAST 6MNTHS- 1 YEAR
•SOFT CONTACT LENS DISCONTINUED FOR MINIMUM 1 WEEK AND RIGID GAS PERMEABLE CONTACT LENS DISCONTINUED FOR MINIMUM 3 WEEKS
•CORNEAL TOPOGRAPHY-MINIMUM CORNEAL THICKNESS 480µ, RESIDUAL CORNEAL THICKNESS ATLEAST 250µ/50% OF ORIGINAL THICKNESS (WHICHEVER IS HIGHER)
•EVIDENCE OF OCULAR DISEASES LIKE MEIBOMIAN GLAND DISEASES, HERPETIC KERATITIS, UVIETIS, GLAUCOMA, VISUALLY SIGNIFICANT CATARACT, RETINAL DISEASES LIKE RETINAL DYSTROPHIES OR DIABETIC RETINOPATHY.
•PROGRESSIVE/UNSTABLE MYOPIA AND/OR ASTIGMATISM
•ANY PATHOLOGIES OF CORNEA LIKE CORNEAL DYSTROPHIES INCLUDING KERATOCONUS,ANY H/O CORNEAL TRAUMA OR SURGERY WITHIN FLAP ZONE
•DRY EYE STATUS-SCHIRMERâ??S 2 TEST VALUE LESS THAN 10 mm
•OCULAR MEDICATION LIKE β BLOCKERS.
•TAKING ANY SYSTEMIC MEDICATION LIKELY TO AFFECT WOUND HEALING LIKE CORTICOSTEROIDS OR ANTIMETABOLITES.
•H/O IMMUNOCOMPROMISED STATE OR PREGNANCY OR NURSING MOTHERS
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare-visual outcome;dry eye status;corneal topography;contrast sensitivity;subjective pain assessment and patient satisfaction between the two proceduresTimepoint: DAY 1,15 AND 90.
- Secondary Outcome Measures
Name Time Method ANY COMPLICATIONS OF SURGERYTimepoint: DAY 1, 15 AND 90