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FEASIBILITY, SAFETY AND OUTCOMES WITH DIFFERENTIAL SPOT SPACING PATTERNS IN EYES UNDERGOING SMILE FOR MYOPIA (NEAR SIGHTEDNESS) CORRECTION- A CONTRALATERAL EYE STUDY

Not Applicable
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
Inclusion Criteria

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

Exclusion Criteria

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
NameTimeMethod
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
NameTimeMethod
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
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