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Research Based on IOLMaster700 Cataract Diagnosis and Classification System

T

Tongji University

Status

Not yet enrolling

Conditions

Cataract
Artificial Intelligence (AI)

Treatments

Device: IOL-MASTER 700

Study type

Observational

Funder types

Other

Identifiers

NCT07022444
SHSY-IEC-4.1/21-314/01

Details and patient eligibility

About

Cataract is a major cause of blindness due to eye diseases. Methods for evaluating the degree of lens opacification in cataracts are divided into subjective and objective methods. The commonly used subjective method is the Lens Opacification Classification System (LOCS Ⅲ), while the objective methods mainly include the Dysfunctional Lens Index (DLI) of the Ray Tracing aberration analysis system, the PNS score of the Pentacam anterior segment analysis system, etc. Subjective diagnosis may lead to certain misjudgments, which have affected clinical diagnosis and treatment. There is an urgent need to add objective diagnostic measures to assist clinical work. The Scanning Source Optical Coherence Tomography (SS - OCT) biometer - IOL Master 700 forms an OCT imaging of the eye based on the swept - source optical coherence tomography (OCT) biometric technology. It can visually show the longitudinal section of the entire lens, and the clear display of the patient's lens tomographic OCT image is obtained through image visualization measurement.

The main purpose of this study is to analyze the lens images obtained by the IOLmaster 700. Based on the current mainstream algorithm models such as ResNet - 34 and XGBoost, develop a heterogeneous accelerated artificial intelligence algorithm according to our research needs to accurately calculate the degree of lens opacification. And write image analysis software by ourselves to automatically calculate the required indicators and output them. Establish a heterogeneous accelerated artificial intelligence - assisted lens opacification grading and prediction system, supporting software for biometer equipment, and a cataract lens image database. The software provides online service functions, and all researchers can use the image analysis function of the software after logging in, truly realizing the sharing of large instrument supporting software operations. Thereby improving the accuracy and efficiency of clinical diagnosis and treatment, the prognostic prediction level of patients after cataract surgery, guiding clinical diagnosis and treatment more accurately, and at the same time, it can be used as a tool for community screening.

Enrollment

2,000 estimated patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • A. Age between 18 and 90 years B. Diagnosed with age-related and/or complicated cataract (diagnosed according to LOCS III classification) C. The patient has signed an informed consent form

Exclusion criteria

  • A. Exclude patients with corneal diseases, uveitis, vitreoretinal diseases, or refractive media opacities caused by conditions such as retinal detachment with silicone oil tamponade B. History of previous ophthalmic disease treatment or surgery C. Poor-quality or missing imaging data D. Pupil diameter < 2.5 mm or loss of fixation during examination, resulting in inability to obtain sufficient lens data

Trial design

2,000 participants in 1 patient group

Cataract patients
Description:
Patients with cataract diagnosed in hospital from October 2019 to October 2024.
Treatment:
Device: IOL-MASTER 700

Trial contacts and locations

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Central trial contact

Yiwen Hu

Data sourced from clinicaltrials.gov

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