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

NCT ID: NCT07146737

Last Updated: 2025-08-28

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

RECRUITING

Total Enrollment

818 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-01

Study Completion Date

2028-12-31

Brief Summary

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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

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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 parameter variability and incomplete utilization of corneal topography data. To address this, we developed a deep learning model that predicts postoperative vault while generating anterior chamber morphology images from preoperative data, enabling personalized surgical planning.

Conditions

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ICL Vault Deep Learning AI (Artificial Intelligence)

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Eyes with ICL surgeries

Eyes with ICL surgeries which were performed by surgeons with experiences.

Corneal tomography generation model after ICL surgery

Intervention Type DIAGNOSTIC_TEST

The ICL procedures collected would be assessed by the corneal tomography generation model. The performance of the model would be assessed, including accuracy,AUC, sensitivity and specificity.

Interventions

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Corneal tomography generation model after ICL surgery

The ICL procedures collected would be assessed by the corneal tomography generation model. The performance of the model would be assessed, including accuracy,AUC, sensitivity and specificity.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital of Nanchang University

OTHER

Sponsor Role lead

Responsible Party

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Fu Gui

Associate research fellow; Attending physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Fu F Gui

Role: CONTACT

+8613879101919

Facility Contacts

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Fu Gui, doctor

Role: primary

+8613879101919

Jian Xiong, doctor

Role: backup

+8618170906556

Other Identifiers

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[2025] NO.(86)

Identifier Type: -

Identifier Source: org_study_id

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