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Comparing Visual Outcomes for cylindrical power correction using 2 advanced techniques for laser vision correction : LASIK & SMILE

Comparing Visual Outcomes of Topo Guided LASIK with Small Incision Lenticule Extraction (SMILE) in eyes with Astigmatism: A prospective contralateral eye study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/11/010607
Enrollment
138
Registered
2017-11-23
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: null- Patients with compound myopic astigmatism wanting to undergo refractive surgery

Interventions

Intervention1: Contoura Guided Laser Assisted Insitu Keratomileusis(LASIK): Comparing Visual Outcomes of Topo Guided LASIK with Small Incision Lenticule Extraction (SMILE) in eyes with Astigmatism: A

Sponsors

DrDRamamurthy
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects 18 years of age or older. 2. Myopia requiring (a) refractive error correction of -0.5 to -8.0 manifest refraction sphere with (b) astigmatism correction of -1.0 D to -5.0Dmanifestrefraction cylinder 3. Intended treatment is targeted for emmetropia. 4. Pre-surgery BCVA of 0 logarithm of the minimum angle of resolution (logMAR) (20/20) or better. 5. Willing and able to complete all post-surgery visits.

Exclusion criteria

Exclusion criteria: 1. Pregnancy or lactation, current or planned, during the course of the study. 2. Mixed astigmatism refractive error. 3. Degenerations of structure of the cornea including diagnosed keratoconus, formefrustekerataconus or pellucid marginal degeneration. 4. History or evidence of active or inactive corneal or other anterior segment disease (e.g, herpes simplex keratitis, recurrent erosionsyndrome). 5. Weakened immune system, including diagnosed collagen vascular, autoimmune or immunodeficiency disease. 6. Co existing Retinal or Optic nerve head co morbidities which could affect the final visual outcome.

Design outcomes

Primary

MeasureTime frame
The primary objective of the study is to evaluate percentage of eyes with manifest refraction cylinder â?¤ 0.5 D at 3 months using the two techniques.Timepoint: The primary objective of the study is to evaluate percentage of eyes with manifest refraction cylinder â?¤ 0.5 D at 3 months using the two techniques.

Secondary

MeasureTime frame
1. Mean refractive cylinder at 3 months 2. Percentage of eyes with atleast 1 line gain in BCVA at 3 months 3. Percentage of eyes with UCVA of 20/20 or better at 3 months Timepoint: 3 months

Countries

India

Contacts

Public ContactShreyas Ramamurthy

The Eye Foundation

shreyas@theeyefoundation.com9894231663

Outcome results

None listed

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