A Randomized Controlled Trial Comparing Clinical Effectiveness of SMILE Versus SMILE Xtra in Myopia

Fudan University

Status: Enrolling

Conditions: Myopia

Treatments: Procedure: SMILE; Procedure: SMILE Xtra

Study type: Interventional

Funder types: Other

Identifiers

NCT06992011

B2024-267R-1

Details and patient eligibility

About

To evaluate and compare the clinical efficacy, biomechanical stability, and optical quality of SMILE and SMILE Xtra procedures in patients with myopia through a randomized controlled trial

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18-50 years
2. MRSE (Manifest Refraction Spherical Equivalent) -6.00D to -10.00D with refractive changes within ±0.50D in past 2 years
3. CDVA (Corrected Distance Visual Acuity) ≥ 20/25
4. Myopia progression ≤ 0.50D/year for ≥2 years
5. RST (Residual Stromal Thickness) ≥ 250μm after lenticule removal
6. Contact lens discontinuation as per protocol

Exclusion criteria

1. Other eye diseases (keratoconus, glaucoma, etc.)
2. Corneal scarring, cataracts affecting observation
3. Systemic diseases affecting surgery compliance
4. Prior ocular surgeries
5. Pregnancy, breastfeeding, or menstruation
6. Drug allergies to surgical medication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

SMILE Group

Active Comparator group

Treatment:

Procedure: SMILE

SMILE Xtra Group

Experimental group

Treatment:

Procedure: SMILE Xtra