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NCT Number: NCT06966622

Comparison of Retinal Damage in ICL Implantation Using 3D Visualization System vs. Microscope

Implantable collamer lens (ICL) implantation is considered one of the most effective surgical treatments for high myopia. The procedure primarily involves adjusting the position of the ICL within the eye. However, precise calculation of the ICL optical power may cause the surgical light source to remain focused on the macular area during this process, potentially leading to iatrogenic light-induced damage. Theoretically, the combination of a 3D visualization surgical system and coaxial illumination technology can reduce the illumination intensity and decrease iatrogenic light damage. This study aims to compare the retinal physiological changes in patients undergoing ICL surgery through 3D visualization surgical system with coaxial illumination versus a traditional microscope with standard illumination.

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Key information

Conditions

High Myopia

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical diagnosis of high myopic
  • Aged 18-40 years
  • Desire to improve their refractive status via ICL surgery
  • Relatively stable refractive error (change ≤ 0.50 D per year for two consecutive years)
  • Central anterior chamber depth ≥ 2.8 mm
  • Open angles
  • Corneal endothelial cell density ≥ 2000 cells/mm2.

Exclusion criteria

  • Cataracts
  • Corneal diseases,
  • Glaucoma,
  • Nystagmus,
  • Strabismus,
  • Lens subluxation,
  • Severe vitreoretinal diseases,
  • Other ocular diseases
  • A history of ocular trauma
  • A history of ocular surgery

Treatment and study plan

3D visualization system with coaxial illumination

Procedure

operation through 3D visualization system with coaxial illumination

microscope with standard illumination

Procedure

operation through microscope with standard illumination

Primary outcomes

  1. b-wave amplitude

    Time frame: 1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op

Secondary outcomes

  1. a-wave amplitude

    Time frame: 1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op

  2. macular vessel density

    Time frame: 1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op

  3. Uncorrected visual acuity

    Time frame: 1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op

  4. Best-corrected visual acuity

    Time frame: 1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op

Other outcomes

  1. Intraoperative illumination intensity

    Time frame: surgery beginning

  2. Surgical time

    Time frame: Starting with the making of the surgical incision and ending with incision closure

Sponsors and collaborators

Lead sponsor

Fuzhou Eye Hospital

Other

Collaborators

  • Alcon Research

Registry information

Official study title

Comparison of Ngenuity and Traditional Microscopy in Assessing Retinal Function Recovery Post-ICL Surgery

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
May 13, 2025
Registry last updated
Aug 8, 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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