NCT07146737

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
818

participants targeted

Target at P75+ for all trials

Timeline
33mo left

Started Jul 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress24%
Jul 2025Dec 2028

Study Start

First participant enrolled

July 1, 2025

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 28, 2025

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Expected
Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

2 days

First QC Date

August 21, 2025

Last Update Submit

August 21, 2025

Conditions

ICLVaultDeep LearningAI (Artificial Intelligence)

Keywords

Implantable Collamer Lens (ICL) implantation surgeryCorneal tomographyvaultArtificial IntelligenceDeep Learning

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

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

    Day 7

Study Arms (1)

Eyes with ICL surgeries

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

Diagnostic Test: Corneal tomography generation model after ICL surgery

Interventions

Corneal tomography generation model after ICL surgeryDIAGNOSTIC_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.

Eyes with ICL surgeries

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

RECRUITING

MeSH Terms

Conditions

T-Lymphocytopenia, Idiopathic CD4-Positive

Condition Hierarchy (Ancestors)

LymphopeniaLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte DisordersImmunologic Deficiency SyndromesImmune System Diseases

Central Study Contacts

Fu F Gui

CONTACT

+8613879101919564436578@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

August 21, 2025

First Posted

August 28, 2025

Study Start

July 1, 2025

Primary Completion

July 3, 2025

Study Completion (Estimated)

December 31, 2028

Last Updated

August 28, 2025

Record last verified: 2025-08

Locations

CN(1)