Study on the Diagnostic Efficacy of ICL Selection and Prediction Depth Model Based on Eye Images

NCT ID: NCT06669728

Last Updated: 2025-08-22

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

326 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-02

Study Completion Date

2025-08-31

Brief Summary

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To evaluate the diagnostic efficacy of deep learning network model in implantable collamer lens selection and prediction in a multicenter cross-sectional study

Detailed Description

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Posterior chamber intraocular lens implantation is an main choice for myopia correction. Implantable collamer lens (ICL) is currently the most widely used, and the official reference index is mainly based on biological parameters obtained from eye images. The parameter acquisition and selection of ICL design are often controversial, forcing the doctors to synthesize multiple modal data, making the optimization of ICL formula being a focus of attention in refractive surgery. This research aimed to build an image-based ICL prediction algorithm to assist human physicians in decision-making and improve the accuracy, safety and predictability of ICL implantation.

Conditions

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Posterior Chamber Phakic Intraocular Lens Vault Deep Neural Network Myopia Anterior Chamber Angle

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 SMILE surgeries which were performed by surgeons with experiences.

AI diagnostic algorithm

Intervention Type DIAGNOSTIC_TEST

The ICL procedures collected would be assessed by the algorithm. The performance of the algorithm would be assessed, including accuracy, AUC, sensitivity and specificity.

Interventions

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AI diagnostic algorithm

The ICL procedures collected would be assessed by the algorithm. The performance of the algorithm would be assessed, including accuracy, AUC, sensitivity and specificity.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Aged 18-45 years ;
2. Myopia, with or without astigmatism, annual diopter change ≤ 0.50 D for 2 consecutive years ;
3. Anterior chamber depth ≥ 2.80 mm ;
4. Corneal endothelial cell count ≥ 2000 / mm2, stable cell morphology ;
5. There were no other ocular diseases that significantly affected vision and / or systemic organic lesions that affected surgical recovery.

Exclusion Criteria

1. There were no other ocular diseases that significantly affected vision and / or systemic organic lesions that affected surgical recovery;
2. Have a history of corneal refractive surgery or intraocular surgery ;
3. Corneal endothelial cell count is low ;
4. Those with systemic diseases ;
5. Lactating or pregnant women.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Second Affiliated Hospital of Nanchang University

OTHER

Sponsor Role lead

Responsible Party

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Jian Xiong

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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Jian Xiong doctor

Role: CONTACT

+8618170906556

Fu Gui docter

Role: CONTACT

+8613879101919

Facility Contacts

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Jian Xiong doctor

Role: primary

+8618170906556

Fu Gui doctor

Role: backup

+8613879101919

Other Identifiers

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[2024] NO.(93)

Identifier Type: -

Identifier Source: org_study_id

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