CClinicalTrials.gg
RecruitingNCT06788418Updated Jan 23, 2025

Comparative Study of SMILE, ICL, and Wavelight Plus Alcon Technologies in Myopia Correction

An interventional study of Wavelight Plus Alcon system and SMILE in Myopia, sponsored by Beijing Visionly Plus Eye Hospital. Recruiting at 2 sites in China. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-01-23.

Sponsored by Beijing Visionly Plus Eye Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started Jan 2025; still recruiting 1 year 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
1,000
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study summary

Myopia is a prevalent refractive error with significant lifestyle impact. While traditional SMILE (Small Incision Lenticule Extraction) and ICL (Implantable Collamer Lens) surgeries are standard options, the advent of the Wavelight Plus Alcon system presents a promising new technique. This trial aims to evaluate the safety, efficacy, and patient satisfaction across these methods.

02

Conditions studied

  • Myopia

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Keywords

  • myopia
  • Small Incision Lenticule Extraction
  • Implantable Collamer Lens
  • Wavelight Plus Alcon system
  • vision
03

In context

Myopia

984 studies on the registry are indexed under Myopia; 210 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 80 across 783 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

Beijing Visionly Plus Eye Hospital is the lead sponsor of 3 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adults aged 18-40 years
  • Spherical equivalent of -1.00 to -10.00 D
  • Stable refraction for at least 12 months
  • Informed consent provided

Exclusion criteria

Exclusion Criteria:

  • Other ocular pathologies
  • Previous refractive surgery
  • Pregnancy or nursing
  • Autoimmune or connective tissue disorders
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
1,000 participants (estimated)

Study arms

  • Experimental
    SMILE Group

    Standard Small Incision Lenticule Extraction (SMILE) procedure using VisuMax laser

    Procedure: SMILE

  • Experimental
    ICL group

    Implantable Collamer Lens (ICL) implantation using the STAAR Surgical Visian ICL

    Procedure: ICL

  • Experimental
    Wavelight Plus Alcon Group

    Laser vision correction using the Wavelight Plus Alcon system

    Procedure: Wavelight Plus Alcon system

Interventions

  • ProcedureWavelight Plus Alcon system

    Wavelight Plus Alcon system guided surgery for myopia

    Also known as: Small Incision Lenticule Extraction, Implantable Collamer Lens

  • ProcedureSMILE

    Small Incision Lenticule Extraction surgery for myopia

  • ProcedureICL

    Implantable Collamer Lens surgery for myopia

06

What researchers measure

Primary outcomes

  1. Vision at 12 months post-surgery

    Uncorrected distance vision (UDVA) at 12 months post-surgery

    Time frame: From the day of surgery through to the 12-month post-operative follow-up

Secondary outcomes

  1. Change in spherical equivalent at 12 months post-surgery

    Change of the spherical equivalent at 12 months post-surgery

    Time frame: From the day of surgery through to the 12-month post-operative follow-up

07

Study locations

2 of 2 sites recruiting
  • Beijing New Vision Eye Hospital
    Beijing, 100020, China
    Recruiting
  • Beijing Visionly Plus Eye Hospital
    Beijing, 100027, China
    Recruiting
08

References and documents

Publications

  • Meng ZY, Yang L, Zhou P. Femtosecond laser versus manual clear corneal incision in implantable collamer lens surgery. Sci Rep. 2025 Jan 7;15(1):1086. doi: 10.1038/s41598-024-81477-w. PubMed 39774960 ↗

Individual participant data

Plan to share: Yes — Only IPD used in the results publication will be shared

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06788418
Lead sponsor
Beijing Visionly Plus Eye Hospital
Collaborators
High Myopia Control Alliance (HIMALAYA), Beijing New Vision Eye Hospital, Shanghai Parkway Hospital
Responsible party
Sponsor
First posted
Jan 23, 2025
Start date
Jan 20, 2025
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Jan 23, 2025

Study contacts

Peng ZHOU, M.D.
Contact
drzhoupeng@gmail.com
+86-18801871108

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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