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

NCT ID: NCT06788418

Last Updated: 2025-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-20

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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SMILE Group

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

Group Type EXPERIMENTAL

SMILE

Intervention Type PROCEDURE

Small Incision Lenticule Extraction surgery for myopia

ICL group

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

Group Type EXPERIMENTAL

ICL

Intervention Type PROCEDURE

Implantable Collamer Lens surgery for myopia

Wavelight Plus Alcon Group

Laser vision correction using the Wavelight Plus Alcon system

Group Type EXPERIMENTAL

Wavelight Plus Alcon system

Intervention Type PROCEDURE

Wavelight Plus Alcon system guided surgery for myopia

Interventions

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Wavelight Plus Alcon system

Wavelight Plus Alcon system guided surgery for myopia

Intervention Type PROCEDURE

SMILE

Small Incision Lenticule Extraction surgery for myopia

Intervention Type PROCEDURE

ICL

Implantable Collamer Lens surgery for myopia

Intervention Type PROCEDURE

Other Intervention Names

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Small Incision Lenticule Extraction Implantable Collamer Lens

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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High Myopia Control Alliance (HIMALAYA)

UNKNOWN

Sponsor Role collaborator

Beijing New Vision Eye Hospital

UNKNOWN

Sponsor Role collaborator

Shanghai Parkway Hospital

UNKNOWN

Sponsor Role collaborator

Beijing Visionly Plus Eye Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Beijing New Vision Eye Hospital

Beijing, , China

Site Status RECRUITING

Beijing Visionly Plus Eye Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Peng ZHOU, M.D.

Role: CONTACT

+86-18801871108

Facility Contacts

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Lin Yang, M.D.

Role: primary

+86-17898805125

References

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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.

Reference Type BACKGROUND
PMID: 39774960 (View on PubMed)

Other Identifiers

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Himalaya202501

Identifier Type: -

Identifier Source: org_study_id

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