Comparison of outcomes in patients undergoing SMILE surgery for refractive errors using two different cones
- Conditions
- Health Condition 1: H521- MyopiaHealth Condition 2: H526- Other disorders of refraction
- Registration Number
- CTRI/2019/01/017149
- Lead Sponsor
- Dr Sri Ganesh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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 <br/ ><br>uncorrected visual acuity (time frame :pre-operative,1 day,15 day & 3months follow-up) <br/ ><br>best corrected visual acuity (time frame: 1 day , 15 day & 3months follow-up) <br/ ><br>A lower LogMAR value indicates better visual acuity <br/ ><br>lower OSI value indicates better visual qualityTimepoint: pre-operative visit,1st day,15 day & 3 months follow-up
- Secondary Outcome Measures
Name Time Method Any adverse eventsTimepoint: day 1, day 15, 3months