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NCT Number: NCT06788418

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

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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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing New Vision Eye Hospital, Beijing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wavelight Plus Alcon system

Procedure

Wavelight Plus Alcon system guided surgery for myopia

Other names: Small Incision Lenticule Extraction, Implantable Collamer Lens

SMILE

Procedure

Small Incision Lenticule Extraction surgery for myopia

ICL

Procedure

Implantable Collamer Lens surgery for myopia

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    Change of the spherical equivalent at 12 months post-surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Peng ZHOU, M.D.

CONTACT

[email protected]

+86-18801871108

Sponsors and collaborators

Lead sponsor

Beijing Visionly Plus Eye Hospital

Other

Collaborators

  • Beijing New Vision Eye Hospital
  • High Myopia Control Alliance (HIMALAYA)
  • Shanghai Parkway Hospital

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 23, 2025
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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