FEASIBILITY, SAFETY AND OUTCOMES WITH DIFFERENTIAL SPOT SPACING PATTERNS IN EYES UNDERGOING SMILE FOR MYOPIA (NEAR SIGHTEDNESS) CORRECTION- A CONTRALATERAL EYE STUDY
- Conditions
- Health Condition 1: H521- Myopia
- Registration Number
- CTRI/2019/01/017174
- 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 Simple Myopia and Myopic Astigmatism
2.Age ( 21-40 years) with no lens changes due to cataract.
3.SEQ difference of 2 D or less between 2 eyes
4.Manifest spherical equivalent - 10 diopters or less
5.Manifest cylinder 1 diopters or less
6.Stable refraction, < 0.50 D change in last 1 year
7.Best spectacle corrected visual acuity of 6/6 or better in both eyes
8.No evidence of irregular astigmatism on corneal topography in both eyes
9.Residual stromal bed thickness (RSBT) â?? at least 280 µm
10.Ability to understand and willing to sign inform consent, to participate in followups
1.Patients having Pure Presbyopia.
2.Patients having hypermetropia, mixed astigmatism with Presbyopia.
3.Eyes in which corneal marking is performed for significant astigmatism( 1D or more)
4.Patients who have undergone any refractive procedure previously.
5.Patients who have undergone cataract surgery.
6.Patients having High Myopia ( >10 D)/ SE > 10D.
7.Anisometropia of 2D or more
8.Amblyopia
9.Progressive or unstable myopia and /or astigmatism
10.Endothelial cell count < 1500 cells/mm2
11.Evidence of ocular surface diseases
12.History of ocular surgery, severe dry eye , corneal degeneration , corneal dystrophy, cataract , uveitis, retinal pathology
13.Kerato-ectatic conditions such as Keratoconus, Keratoconus suspects, Pellucid marginal degeneration etc
14.Concurrent use of medication likely to affect interface healing
15.Immunocompromised state / pregnancy / nursing mothers/ cancer patients
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To study the feasibility, safety and comparison of intraoperative ease of dissection with differential versus standard SMILE spot spacing pattern in eyes undergoing bilateral SMILE for myopia or myopic astigmatism.Timepoint: PREOPERATIVE VISIT, POD 1, POD 15, 3 MONTHS FOLLOW UP
- Secondary Outcome Measures
Name Time Method To compare the clinical outcomes such as visual outcomes including immediate visual acuity, optical quality, contrast sensitivity, aberrations, corneal biomechanics and patient satisfaction between the two spot spacing patterns( differential and standard).Timepoint: PREOPERATIVE VISIT, POD 1, POD 15, 3 MONTHS FOLLOW UP