MyopiaNCT06788418
Comparative Study of SMILE, ICL, and Wavelight Plus Alcon Technologies in Myopia Correction
A study testing Wavelight Plus Alcon system, SMILE and ICL in people with Myopia, run by Beijing Visionly Plus Eye Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Myopia
- What is being tested?
- Wavelight Plus Alcon system, SMILE and ICL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 2 sitesChina
- Study dates
- 20 Jan 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18-40 years
- Spherical equivalent of -1.00 to -10.00 D
- Stable refraction for at least 12 months
- Informed consent provided
Who cannot join
- Other ocular pathologies
- Previous refractive surgery
- Pregnancy or nursing
- Autoimmune or connective tissue disorders
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Beijing New Vision Eye Hospital
Beijing, 100020
Lin Yang, M.D., +86-17898805125, roc001cn@gmail.com
- Recruiting
Beijing Visionly Plus Eye Hospital
Beijing, 100027
About this study
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.
- Conditions
- Myopia
- Being tested
- Wavelight Plus Alcon system, SMILE, ICL
- Keywords
- myopia, Small Incision Lenticule Extraction, Implantable Collamer Lens, Wavelight Plus Alcon system, vision
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wavelight Plus Alcon systemProcedure or surgery
Also called Small Incision Lenticule Extraction, Implantable Collamer Lens
Wavelight Plus Alcon system guided surgery for myopia
SMILEProcedure or surgery
Small Incision Lenticule Extraction surgery for myopia
ICLProcedure or surgery
Implantable Collamer Lens surgery for myopia
| Study group | Role | What they receive |
|---|---|---|
| SMILE Group | Experimental | Standard Small Incision Lenticule Extraction (SMILE) procedure using VisuMax laser Receives: Procedure: SMILE |
| ICL group | Experimental | Implantable Collamer Lens (ICL) implantation using the STAAR Surgical Visian ICL Receives: Procedure: ICL |
| Wavelight Plus Alcon Group | Experimental | Laser vision correction using the Wavelight Plus Alcon system Receives: Procedure: Wavelight Plus Alcon system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vision at 12 months post-surgery
Uncorrected distance vision (UDVA) at 12 months post-surgery
Measured: 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
Measured: From the day of surgery through to the 12-month post-operative follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start20 Jan 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Visionly Plus Eye Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- High Myopia Control Alliance (HIMALAYA), Beijing New Vision Eye Hospital, Shanghai Parkway Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06788418
- Sponsor's protocol ID
- Himalaya202501
- Status last verified
- Jan 2025
- First submitted
- 22 Jan 2025
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only IPD used in the results publication will be shared
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of SMILE, ICL, and Wavelight Plus Alcon Technologies in Myopia Correction
- ClinicalTrials.gov ID
- NCT06788418
- Acronym / sponsor ID
- Himalaya202501
- Conditions
- Myopia
- Keywords
- myopia, Small Incision Lenticule Extraction, Implantable Collamer Lens, Wavelight Plus Alcon system, vision
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Beijing Visionly Plus Eye HospitalUniversity, hospital or other
- Collaborators
- High Myopia Control Alliance (HIMALAYA), Beijing New Vision Eye Hospital, Shanghai Parkway Hospital
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SMILE Group | Experimental | Procedure: SMILEStandard Small Incision Lenticule Extraction (SMILE) procedure using VisuMax laser |
| ICL group | Experimental | Procedure: ICLImplantable Collamer Lens (ICL) implantation using the STAAR Surgical Visian ICL |
| Wavelight Plus Alcon Group | Experimental | Procedure: Wavelight Plus Alcon systemLaser vision correction using the Wavelight Plus Alcon system |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults aged 18-40 years
- Spherical equivalent of -1.00 to -10.00 D
- Stable refraction for at least 12 months
- Informed consent provided
Key exclusion criteria (4 listed)
- Other ocular pathologies
- Previous refractive surgery
- Pregnancy or nursing
- Autoimmune or connective tissue disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wavelight Plus Alcon systemAlso: Small Incision Lenticule Extraction, Implantable Collamer LensWavelight Plus Alcon system guided surgery for myopia | Procedure or surgery | Wavelight Plus Alcon Group |
| SMILESmall Incision Lenticule Extraction surgery for myopia | Procedure or surgery | SMILE Group |
| ICLImplantable Collamer Lens surgery for myopia | Procedure or surgery | ICL group |
Primary outcome
Vision at 12 months post-surgery
Time frame: From the day of surgery through to the 12-month post-operative follow-up
Uncorrected distance vision (UDVA) at 12 months post-surgery
1 secondary outcome
Change in spherical equivalent at 12 months post-surgery
Time frame: From the day of surgery through to the 12-month post-operative follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Results publication: PubMed 39774960Meng 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.
- Individual participant dataSharing planned: Yes. Only IPD used in the results publication will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wavelight Plus Alcon system, SMILE and ICL in people with Myopia, run by Beijing Visionly Plus Eye Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peng ZHOU, M.D. (+86-18801871108, drzhoupeng@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vision at 12 months post-surgery (time frame: From the day of surgery through to the 12-month post-operative follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06788418, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.