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

N/ARecruitingNCT06992011

Shanghai Zhongshan Hospital300 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

300

Conditions

Myopia

Interventions

SMILEPROCEDURE

Small Incision Lenticule Extraction

SMILE XtraPROCEDURE

Small Incision Lenticule Extraction combined with Corneal Cross-linking (SMILE Xtra)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

visual acuity

Time frame: 1 week, 1 month,3 months， 6 months, 12 months, 24 months, and 36 months

Central Contacts

Cong Jing

CONTACT

17269769976 lucky_congjing@163.com

Data from ClinicalTrials.gov

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