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

NCT06669728 | Recruiting

• 1 other identifier: [2024] NO.(93)
• Study Type: observational
• Target: 326
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Posterior Chamber Phakic Intraocular Lens; Vault; Deep Neural Network

Outcome Measures

Primary Outcomes (2)

• AUROC of convolutional neural network in predicting vault after ICL surgery

  The area under the receiver operating characteristic of convolutional neural network in predicting vault after ICL surgery

  Day 7

• AUROC of convolutional neural network in predicting anterior chamber angle after ICL implantation

  The area under the receiver operating characteristic of convolutional neural network in predicting anterior chamber angle after ICL implantation

  Day 7

Secondary Outcomes (2)

• Sensitivity and specificity of convolutional neural network in predicting Vault after ICL implantation

  Day 7

• Sensitivity and specificity of convolutional neural network in predicting anterior chamber angle after ICL implantation

  Day 7

Study Arms (1)

Eyes with ICL surgeries

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

Diagnostic Test: AI diagnostic algorithm

Interventions

AI diagnostic algorithm 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.

Eyes with ICL surgeries

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients from clinics in different eye centers across China. Each subject must with complete surgical video recording and medical records.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Second Affiliated Hospital of Nanchang University: lead

Study Sites (1)

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330000, China

RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

Jian Xiong doctor

CONTACT

+8618170906556; 894040417@qq.com

Fu Gui docter

CONTACT

+8613879101919; 564436578@qq.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate research fellow; Attending physician

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 1, 2024
• Study Start: January 2, 2021
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)