Myopia
Conditions
Keywords
myopia, Small Incision Lenticule Extraction, Implantable Collamer Lens, Wavelight Plus Alcon system, vision
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.
Interventions
PROCEDUREWavelight Plus Alcon system
Wavelight Plus Alcon system guided surgery for myopia
PROCEDURESMILE
Small Incision Lenticule Extraction surgery for myopia
PROCEDUREICL
Implantable Collamer Lens surgery for myopia
Sponsors
High Myopia Control Alliance (HIMALAYA)
Beijing New Vision Eye Hospital
Shanghai Parkway Hospital
Beijing Visionly Plus Eye Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
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
* Other ocular pathologies * Previous refractive surgery * Pregnancy or nursing * Autoimmune or connective tissue disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vision at 12 months post-surgery | From the day of surgery through to the 12-month post-operative follow-up | Uncorrected distance vision (UDVA) at 12 months post-surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in spherical equivalent at 12 months post-surgery | From the day of surgery through to the 12-month post-operative follow-up | Change of the spherical equivalent at 12 months post-surgery |
Countries
China
Contacts
Primary ContactPeng ZHOU, M.D.
Outcome results
None listed