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

NCT06966622 | Not Yet Recruiting

• 1 other identifier: FZYKYY-KY-2025-002
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

High Myopia

Outcome Measures

Primary Outcomes (1)

• b-wave amplitude

  1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op

Secondary Outcomes (4)

• a-wave amplitude

  1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op

• macular vessel density

  1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op

• Uncorrected visual acuity

  1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op

• Best-corrected visual acuity

  1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op

Other Outcomes (2)

• Intraoperative illumination intensity

  surgery beginning

• Surgical time

  Starting with the making of the surgical incision and ending with incision closure

Study Arms (2)

3D visualization system

EXPERIMENTAL

Procedure: 3D visualization system with coaxial illumination

Microscope

ACTIVE COMPARATOR

Procedure: microscope with standard illumination

Interventions

3D visualization system with coaxial illumination PROCEDURE

operation through 3D visualization system with coaxial illumination

3D visualization system

microscope with standard illumination PROCEDURE

operation through microscope with standard illumination

Microscope

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fuzhou Eye Hospital: lead
• Alcon Research: collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2025
• First Posted: May 13, 2025
• Study Start: August 25, 2025
• Primary Completion: November 30, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-05