Validation of an Artificial Intelligence System for Postoperative Management of Cataract Patients

Sponsor

Sun Yat-sen University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04138771

Collaborator

Ministry of Health, China (Other), Xidian University (Other)

300

Enrollment

Location

Arm

85.9

Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Cataract surgery is the current standard of management for cataract patients, which is typically succeeded by a postoperative follow-up schedule. Here, the investigators established and validated an artificial intelligence system to achieve automatic management of postoperative patients based on analyses of visual acuity, intraocular pressure and slit-lamp images. The management strategy can also change according to postoperative time.

Condition or Disease	Intervention/Treatment	Phase
Cataract Postoperative Complications Artificial Intelligence	Device: An artificial intelligence system for postoperative management of cataract patients	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Validation of an Artificial Intelligence System for Postoperative Management of Cataract Patients: A Clinical Trial

Study Start Date :

Jan 1, 2013

Anticipated Primary Completion Date :

Mar 1, 2020

Anticipated Study Completion Date :

Mar 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Eligible patients for AI test Device: an artificial intelligence system for postoperative management of cataract patients. These patients are enrolled in primary healthcare units and the AI clinic at Zhongshan Ophthalmic Center.	Device: An artificial intelligence system for postoperative management of cataract patients This system can detect multiple postoperative complications of cataract patients and then provide a management strategy.

Arm

Intervention/Treatment

Experimental: Eligible patients for AI test

Device: an artificial intelligence system for postoperative management of cataract patients. These patients are enrolled in primary healthcare units and the AI clinic at Zhongshan Ophthalmic Center.

Device: An artificial intelligence system for postoperative management of cataract patients

This system can detect multiple postoperative complications of cataract patients and then provide a management strategy.

Outcome Measures

Primary Outcome Measures

The proportion of accurate, mistaken and miss detection of this artificial intelligence diagnostic system. [Up to 7 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients who had surgery of cataract extraction combined with introcular lens implantation.
Patients should be aware of the contents and signed for the informed consent.