To compare the visual outcomes of two refractive surgery procedures Small Incision Lenticule Extraction and ICL in patients of moderate refractive error

To compare visual outcomes and patient satisfaction levels in patients undergoing implantable Collamer lens ICL implantation versus Small Incision Lenticule Extraction in cases of moderate myopia and myopic astigmatism - Nil

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/092265

Enrollment

100

Registered

2025-08-04

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

None listed

Interventions

Intervention1: SMILE AND ICL: After randomisation into two groups one group patients will undergo Small Incision Lenticule Extraction (SMILE) and the other group will undergo Implantable Collamer Lens

Eligibility

Inclusion criteria

Inclusion criteria: Spherical equivalent of negative 3 to negative 6 Dioptres Refractive cylinder less than or equal to 2 Dioptres Best spectacle-corrected visual acuity of 20 by 40 or better A spherical or cylindrical error that has progressed at negative half Dioptres or less per year before the baseline measurement. The contact lens must have been removed at least two weeks before the baseline measurement. No evidence of irregular astigmatism on corneal topography Anterior chamber depth more than or equal to two point eight millimetre Corneal endothelial cell count more than or equal to two thousand cells per square millimetre

Exclusion criteria

Exclusion criteria: Progressive or unstable myopia and astigmatism Clinical or corneal topographic evidence of keratoconus Residual recurrent or active ocular disease and retinal disease Previous corneal surgery Thinnest Pachymetry les than or equal to four hundred ninety micrometre Residual Stromal Bed less than or equal to two hundred and eighty micrometre in patients undergoing Small Incision Lenticule extraction Taking systemic medications and systemically immunocompromised or systemic diseases likely to affect wound healing such as diabetes connective tissue disease and severe atopy pregnant or nursing females.

Design outcomes

Primary

Measure	Time frame
1)Objectively measure pre- and post-operative higher-order ocular aberrations, including spherical aberration, vertical coma, trefoil, tetrafoil, and contrast sensitivity and subjectively use a quality of vision questionnaire to assess the same.Timepoint: Day 01 01 week 01 month 03 months 06 months 12 months 18 months and 21 months	—

Secondary

Measure	Time frame
Assessment of Uncorrected and corrected visual acuity, efficacy and safety of the procedure, and endothelial cell count between two groups. Timepoint: Day 01 01 week 01 months 03 months 06 months 12 months 18 months 21 months	—

Countries

India

Contacts

Public ContactSupriya Dhar

Army Hospital RR Delhi Cantt

supreme4995@live.com8974795579

Outcome results