NCT06992011

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Feb 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress82%
Feb 2023Feb 2027

Study Start

First participant enrolled

February 1, 2023

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 19, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 28, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

May 28, 2025

Status Verified

May 1, 2025

Enrollment Period

4 years

First QC Date

May 19, 2025

Last Update Submit

May 19, 2025

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

  • visual acuity

    1 week, 1 month,3 months， 6 months, 12 months, 24 months, and 36 months

Study Arms (2)

SMILE Group

ACTIVE COMPARATOR
Procedure: SMILE

SMILE Xtra Group

EXPERIMENTAL
Procedure: SMILE Xtra

Interventions

SMILEPROCEDURE

Small Incision Lenticule Extraction

SMILE Group
SMILE XtraPROCEDURE

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

SMILE Xtra Group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Central Study Contacts

Cong Jing

CONTACT

17269769976lucky_congjing@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2025

First Posted

May 28, 2025

Study Start

February 1, 2023

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

May 28, 2025

Record last verified: 2025-05

Locations

CN(1)