Comparison of outcomes in patients undergoing SMILE surgery for refractive errors using two different cones
- Conditions
- Myopia, (2) ICD-10 Condition: H526||Other disorders of refraction,
- Registration Number
- CTRI/2019/01/017149
- Lead Sponsor
- Dr Sri Ganesh
- Brief Summary
The present contralateral eye study would be conducted with the aim of assessing the outcomes and visual quality using medium versus small sized cone for docking during the procedure of Relex Smile with large corneal diameters for myopia correction .moreover ,to compare clinical outcomes including immediate visual quality, contrast sensitivity, aberrations,corneal biomechanics and patient satisfaction
Thirty patients fulfilling the inclusion criteria will be enrolled in the study.righ and left eye of the patient will be randomised into two groups ,in one eye medium sized cone and other eye small sized cone will be used .energy parameters in both eyes will be same
Post surgery patients will be followed up on day 1 , 2 weeks and 3 months , the pre -operative investigations will be repeated during the follow up visits and adverse events will be documented and duly informed to Ethics Committee.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 30
1.patients with myopia with or without astigmatism 2.manifest spherical equivalent between 3-10 diopters 3.stable refraction of less than 0.50 D change in last 1 year 4.white to white diameter more than or equal to 12 mm 5.cdva of 6/6 0r better in both eyes 6.residual stroll bed thickness of 280 micron or more 7.ability to understand and willingness to sign inform consent and participate in follow up visits.
1.patient not able to lie in horizontal position 2.patient not able to understand and give informed consent 3.significant dry eye or lid and adnexal disease 4.herpes viral infection 5.diabetes 6.pregnant or nursing women 7.patients with a weight of more than 135kg 8.treatment with systemic medication which influence wound healing 9.medication with the active substance isotretinoin 10.previous intraocular or corneal surgery 11.disorder of cornea 12.keratoconus 13.corneal dystrophies 14.corneal scars 15.cataract 16.glaucoma suspect 17.patients with unstable refractive error 18.anisometropia of 2D or more 19.residual stroll bed thickness less than 250 micron 20.patient who have undergone cataract surgery 21.age related macular degeneration.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method clinical outcome and visual quality (time frame : pre-operative visit,1st day,15 days and 3months follow-up pre-operative visit,1st day,15 day & 3 months follow-up A lower LogMAR value indicates better visual acuity pre-operative visit,1st day,15 day & 3 months follow-up uncorrected visual acuity (time frame :pre-operative,1 day,15 day & 3months follow-up) pre-operative visit,1st day,15 day & 3 months follow-up best corrected visual acuity (time frame: 1 day , 15 day & 3months follow-up) pre-operative visit,1st day,15 day & 3 months follow-up lower OSI value indicates better visual quality pre-operative visit,1st day,15 day & 3 months follow-up
- Secondary Outcome Measures
Name Time Method Any adverse events day 1, day 15, 3months
Trial Locations
- Locations (1)
Nethradhama Superspeciality eye hospital
🇮🇳Bangalore, KARNATAKA, India
Nethradhama Superspeciality eye hospital🇮🇳Bangalore, KARNATAKA, IndiaDr Sri GaneshPrincipal investigator9845129740phacomaverick@gmail.com