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Comparison of outcomes in patients undergoing SMILE surgery for refractive errors using two different cones

Comparison of clinical outcomes and visual quality using medium versus small cone in patients undergoing Relex Smile with large corneal diameters

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/01/017149
Enrollment
30
Registered
2019-01-17
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 Health Condition 2: H526- Other disorders of refraction

Interventions

Intervention1: medium cone: medium cone during smile Control Intervention1: small cone: small cone during SMILE

Sponsors

Dr Sri Ganesh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
clinical outcome and visual quality (time frame : pre-operative visit,1st day,15 days and 3months follow-up uncorrected visual acuity (time frame :pre-operative,1 day,15 day & 3months follow-up) best corrected visual acuity (time frame: 1 day , 15 day & 3months follow-up) A lower LogMAR value indicates better visual acuity lower OSI value indicates better visual qualityTimepoint: pre-operative visit,1st day,15 day & 3 months follow-up

Secondary

MeasureTime frame
Any adverse eventsTimepoint: day 1, day 15, 3months

Countries

India

Contacts

Public Contactdr sri ganesh

Nethradhama Superspeciality Eye Hospital

phacomaverick@gmail.com

Outcome results

None listed

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