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It is a clinical trial to measure the efficacy and safety of SMILE( Small Incision Lenticule Extraction) surgery across different grades of myopia

Comparison of visual and refractive outcomes of Small Incision Lenticule Extraction in mild ? moderate vs high Myopia - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/094092
Enrollment
48
Registered
2025-09-02
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Health Condition 1: H542- Low vision, both eyes

Interventions

Intervention1: Small Incision Lenticule Extraction surgery: VisuMax 800. This is a laser based surgery done to correct myopia. It will be done in both the groups greater than and less than 6 D myopia

Sponsors

Maulana Azad Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age more than 18 years Stable refraction for 1 year prior to surgery Minimum preoperative corneal thickness of 480 microns Predicted residual stromal bed thickness morethan 280 microns Patients wearing soft contact lenses will be instructed to stop wearing them for at least 1 week

Exclusion criteria

Exclusion criteria: Patients with history of trauma , prior ocular surgery or corneal scars Keratoconus/ectatic corneal disorders Pregnancy or Lactation History of herpes keratitis Uncontrolled Glaucoma

Design outcomes

Primary

MeasureTime frame
Proportional change in uncorrected visual acuity(UCVA)Timepoint: 3 months

Secondary

MeasureTime frame
1) Proportional change in best corrected visual acuity(BCVA) at 3 months 2) Proportion of patients with Residual refractive error (spherical equivalent) at 3 months 3) Proportional change in Higher order aberrations of the total, anterior and posterior cornea surface at 6mm pupil size at 3 months(RMS, 3RD and 4th order HOA s) 4) Mean change in corneal densitometry of 0-2, 2-6 and 6-10mm concentric optical zones at 1 month and 3 months Timepoint: 3 months

Countries

India

Contacts

Public ContactKapil Chalana

Guru Nanak Eye Centre

kapilchalana1998@gmail.com9871748272

Outcome results

None listed

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