Status:

RECRUITING

Predictive Performance of a Generative Model for Corneal Tomography After ICL Implantation

Lead Sponsor:

Second Affiliated Hospital of Nanchang University

Conditions:

ICL

Vault

Eligibility:

All Genders

18-45 years

Brief Summary

To evaluate the efficacy of a corneal tomography Imaging model in predicting postoperative vault based on preoperative corneal topography in Implantable Collamer Lens (ICL) surgery.

Detailed Description

Accurate vault prediction is crucial for Implantable Collamer Lens (ICL) surgery safety and efficacy. Current methods using preoperative biometrics and regression formulas show limited accuracy due to...

Eligibility Criteria

Inclusion

  • (1) stable myopia (≤0.50D/year change for 2 years), (2) ACD ≥2.80mm, (3) intact corneal endothelium (≥2000 cells/mm²), and (4) no confounding ocular/systemic conditions.

Exclusion

  • (1) glaucoma-spectrum disorders or retinal vasculopathies, (2) prior corneal/intraocular surgery, (3) compromised corneal endothelium, (4) uncontrolled systemic diseases, and (5) pregnancy/lactation.

Key Trial Info

Start Date :

July 1 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 31 2028

Estimated Enrollment :

818 Patients enrolled

Trial Details

Trial ID

NCT07146737

Start Date

July 1 2025

End Date

December 31 2028

Last Update

August 28 2025

Active Locations (1)

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The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China