Skip to content

Correction of cylinder power using SMILE procedure

Efficacy of Small Incision Lenticule Extraction (SMILE) in pure astigmatism - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/084818
Enrollment
75
Registered
2025-04-15
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Health Condition 1: H537- Vision sensitivity deficiencies

Interventions

Intervention1: SMILE PRO: Small Incision Lenticule Extraction for the correction of pure astigmatism ranging from -0.75 DC to -3.50 DC Control Intervention1: nil: nil

Sponsors

Nethradhama super speciality hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients who underwent ReLEX SMILE for correction of simple myopic astigmatism -0.75 to -3.5diopters(D). 2. Stable refractionsince past 12 months. 3. Best spectale-corrected visual acuity of 6/6 . 4. Discontinuation of soft contact lenses 1 week and rigid contact lenses 3 weeks prior. 5. No evidence of irregular astigmatism on corneal topography in both eyes. 6. Residual stromal bed thickness(RSBT) 7. Spherical power

Exclusion criteria

Exclusion criteria: 1. Kerato-ectatic conditions such as keratoconus, keratoconus suspects, pellucid marginal degeneration etc. 2. Patients having simple myopia, hypermetropia, mixed astigmatism and presbyopia 3. Patients who have undergone any refractive procedure previously 4. History of ocular surgery, severe dry eye, corneal degeneration, corneal dystrophy, cataract, uveitis, retinal pathology 5. Concurrent use of medication likely to affect interface healing 6. Immunocompromised state/pregnancy/nursing mothers/cancer patients

Design outcomes

Primary

MeasureTime frame
percentage of patient achieving visual acuity 20/20 or better. percentage eyes within + or - 0.5 D and + or - 1.0 D of astigmatismTimepoint: post op day 1,15 and 3 months

Secondary

MeasureTime frame
percentage eyes within + or - 0.5 D and + or - 1.0 D of astigmatismTimepoint: post op day 1,15 and 3 months

Countries

India

Contacts

Public ContactDr Vidyashree police patil

Nethradhama super speciality eye hospital

vspatil860@gmail.com8310796483

Outcome results

None listed

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