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

NCT ID: NCT06966622

Last Updated: 2025-08-08

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-25

Study Completion Date

2026-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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High Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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3D visualization system

Group Type EXPERIMENTAL

3D visualization system with coaxial illumination

Intervention Type PROCEDURE

operation through 3D visualization system with coaxial illumination

Microscope

Group Type ACTIVE_COMPARATOR

microscope with standard illumination

Intervention Type PROCEDURE

operation through microscope with standard illumination

Interventions

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3D visualization system with coaxial illumination

operation through 3D visualization system with coaxial illumination

Intervention Type PROCEDURE

microscope with standard illumination

operation through microscope with standard illumination

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role collaborator

Fuzhou Eye Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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FZYKYY-KY-2025-002

Identifier Type: -

Identifier Source: org_study_id

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