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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/01/017174
Enrollment
50
Registered
2019-01-21
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H521- Myopia

Interventions

Intervention1: FEASIBILITY, SAFETY AND OUTCOMES WITH DIFFERENTIAL SPOT SPACING PATTERNS IN EYES UNDERGOING SMILE FOR MYOPIA CORRECTION: A CONTRALATERAL EYE STUDY Intervention2: DIFFERENTIAL SPOT SPACI

Sponsors

DR SRI GANESH
Lead Sponsor

Eligibility

Inclusion criteria

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, 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

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 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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—

Countries

India

Contacts

Public ContactDR SRI GANESH

MS, DNB

phacomaverick@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026