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Comparison of two laser platforms of myopia vision correction

Comparison of Next Generation Laser Techniques of Myopia Correction: iDesign vs. SMILE

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/12/010946
Enrollment
100
Registered
2017-12-21
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 opting for refractive surgery for correction of myopia and astigmatism

Interventions

Intervention1: Wavefront guided laser assisted in situ keratomileusis: One group will undergo Wavefront guided laser assisted in situ keratomileusis using iDesign platform (Johnson and Johnson, USA).

Sponsors

Narayana Nethralaya
Lead Sponsor
Abbott Medical Optics
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Patients should be between 18 to 50 years of age. Patient must have stable myopia for a minimum period of one year (a change of 0.25D or less) as documented by prior clinical records or current spectacle correction. Patient must have a corrected distance visual acuity (CDVA) of 0.8 or better Patient must have a spherical equivalent refraction less than â??10D Patient must have refractive astigmatism less than 3D

Exclusion criteria

Exclusion criteria: Patient must not have a central corneal thickness less than 480 micrometer Patient must not have a calculated residual stromal bed thickness of less than 250 micrometer after the surgery Patient must not have symptoms or signs of keratoconus, diabetes, collagen vascular disease, pregnancy, breastfeeding and any prior ocular surgery. Patient must not have an interocular difference of more than 1.00 diopter of spherical or 0.50 D of cylindrical refractive error. Patient must not be on chronic systemic steroids or other medication that can affect wound healing. Patient must not be allergic to primary or alternative medications. Patient must not be using rigid contact lenses for the last three weeks or soft contact lenses for at least 1 week before the preoperative evaluation

Design outcomes

Primary

MeasureTime frame
Uncorrected and distance visual acuity, Wavefront aberrometryTimepoint: Pre-surgery, 1 month, 3 month, 6 month

Secondary

MeasureTime frame
Corneal tomography, Biomechanics of the cornea, ocular surface discomfort (OSDI score)Timepoint: Pre-surgery, 1 month, 3 month, 6 month

Countries

India

Contacts

Public ContactRohit Shetty

Narayana Nethralaya

drrohitshetty@yahoo.com9611102568

Outcome results

None listed

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