A Randomized Controlled Trial Comparing Clinical Effectiv... | NCT06992011

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

NCT06992011

Sponsor

Shanghai Zhongshan Hospital

Status

Recruiting

Last Update Posted

May 28, 2025Actual

Enrollment

300Estimated

Phase

Not Applicable

Conditions

Myopia

Interventions

SMILE
SMILE Xtra

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2023Actual

Primary Completion Date

Feb 2027Estimated

Completion Date

Feb 2027Estimated

First Submitted Date

May 19, 2025

First Submission Date that Met QC Criteria

May 19, 2025

First Posted Date

May 28, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 19, 2025

Last Update Posted Date

May 28, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SMILE Group	Active Comparator		Procedure: SMILE
SMILE Xtra Group	Experimental		Procedure: SMILE Xtra

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SMILE	Procedure	Small Incision Lenticule Extraction	SMILE Group
SMILE Xtra

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
visual acuity		1 week, 1 month,3 months， 6 months, 12 months, 24 months, and 36 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Cong Jing	Contact	17269769976		lucky_congjing@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhongshan Hospital	Recruiting	Shanghai	Shanghai Municipality	200032	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41781518	Derived	Cong J, Lin X, Yuan J, Li X, Liu W, Mao X, Zheng C, Liu S, Feng Q, Dong C, Feng C, Yuan Y, Dai J. Comparing Efficacy and Corneal Biomechanics Between KLEx and KLEx Xtra in High Myopia: A 1-Year Prospective Randomized Study. Ophthalmol Ther. 2026 Apr;15(4):1355-1374. doi: 10.1007/s40123-026-01340-1. Epub 2026 Mar 4.

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases