NCT06973278

Brief Summary

To evaluate the clinical efficacy and refractive stability of SMILE Xtra compared to SMILE in patients with myopia

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200

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 7, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 15, 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 15, 2025

Status Verified

May 1, 2025

Enrollment Period

4 years

First QC Date

May 7, 2025

Last Update Submit

May 7, 2025

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

  • visual acuity

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

Study Arms (2)

SMILE Group

ACTIVE COMPARATOR
Procedure: SMILE

SMILE Xtra

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

Eligibility Criteria

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

You may qualify if:

  • Age between 18 and 50 years.
  • High myopia with a manifest refraction spherical equivalent (MRSE) - 6.00D～-10.00D and refractive changes within ± 0.50D in the past two years;
  • Best corrected distance visual acuity (CDVA) ≥ 20/25.
  • Preoperative refractive status is stable (myopia progression not exceeding 0.50D per year for at least 2 years).
  • Predicted residual stromal thickness (RST) ≥ 250μm after lenticule removal. 6.Soft contact lenses discontinued for at least 1 week, rigid contact lenses for at least 3 weeks, and orthokeratology lenses for at least 3 months.

You may not qualify if:

  • The presence of other eye diseases: keratoconus or suspected keratoconus, active keratoconjunctivitis, severe dry eye, glaucoma, retinal diseases such as retinal tears or macular degeneration, etc.,
  • The presence of significant corneal scarring or cataracts affects observation.
  • Systemic diseases such as active systemic inflammation, connective tissue diseases, other conditions that prevent

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
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2025

First Posted

May 15, 2025

Study Start

February 1, 2023

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

May 15, 2025

Record last verified: 2025-05

Locations

CN(1)