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| Name | Class |
|---|---|
| High Myopia Control Alliance (HIMALAYA) | UNKNOWN |
| Beijing New Vision Eye Hospital | UNKNOWN |
| Shanghai Parkway Hospital | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SMILE Group | Experimental | Standard Small Incision Lenticule Extraction (SMILE) procedure using VisuMax laser |
|
| ICL group | Experimental | Implantable Collamer Lens (ICL) implantation using the STAAR Surgical Visian ICL |
|
| Wavelight Plus Alcon Group | Experimental | Laser vision correction using the Wavelight Plus Alcon system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wavelight Plus Alcon system | Procedure | Wavelight Plus Alcon system guided surgery for myopia |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in spherical equivalent at 12 months post-surgery | Change of the spherical equivalent at 12 months post-surgery | From the day of surgery through to the 12-month post-operative follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peng ZHOU, M.D. | Contact | +86-18801871108 | drzhoupeng@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing New Vision Eye Hospital | Recruiting | Beijing | 100020 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39774960 | Result | 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. |
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Only IPD used in the results publication will be shared
January 2025-January 2027
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| SMILE | Procedure | Small Incision Lenticule Extraction surgery for myopia |
|
| ICL | Procedure | Implantable Collamer Lens surgery for myopia |
|
| Beijing Visionly Plus Eye Hospital | Recruiting | Beijing | 100027 | China |