Comparative Study of SMILE, ICL, and Wavelight Plus Alcon Technologies in Myopia Correction
1 other identifier
interventional
1,000
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2025
2 active sites
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 Start
First participant enrolled
January 20, 2025
CompletedFirst Submitted
Initial submission to the registry
January 22, 2025
CompletedFirst Posted
Study publicly available on registry
January 23, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedJanuary 23, 2025
January 1, 2025
12 months
January 22, 2025
January 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Vision at 12 months post-surgery
Uncorrected distance vision (UDVA) at 12 months post-surgery
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
From the day of surgery through to the 12-month post-operative follow-up
Study Arms (3)
SMILE Group
EXPERIMENTALStandard Small Incision Lenticule Extraction (SMILE) procedure using VisuMax laser
ICL group
EXPERIMENTALImplantable Collamer Lens (ICL) implantation using the STAAR Surgical Visian ICL
Wavelight Plus Alcon Group
EXPERIMENTALLaser vision correction using the Wavelight Plus Alcon system
Interventions
Wavelight Plus Alcon system guided surgery for myopia
Eligibility Criteria
You may qualify if:
- Adults aged 18-40 years
- Spherical equivalent of -1.00 to -10.00 D
- Stable refraction for at least 12 months
- Informed consent provided
You may not qualify if:
- Other ocular pathologies
- Previous refractive surgery
- Pregnancy or nursing
- Autoimmune or connective tissue disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beijing Visionly Plus Eye Hospitallead
- High Myopia Control Alliance (HIMALAYA)collaborator
- Beijing New Vision Eye Hospitalcollaborator
- Shanghai Parkway Hospitalcollaborator
Study Sites (2)
Beijing New Vision Eye Hospital
Beijing, 100020, China
Beijing Visionly Plus Eye Hospital
Beijing, 100027, China
Related Publications (1)
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.
PMID: 39774960BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2025
First Posted
January 23, 2025
Study Start
January 20, 2025
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
January 23, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- January 2025-January 2027
Only IPD used in the results publication will be shared