Actively Recruiting
Predictive Performance of a Generative Model for Corneal Tomography After Implantable Collamer Lens Implantation
Led by Second Affiliated Hospital of Nanchang University · Updated on 2025-08-28
818
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to assess the effectiveness of a corneal tomography imaging model in predicting postoperative vault after Implantable Collamer Lens (ICL) surgery. Accurate prediction of vault is important for the safety and success of ICL surgery. Current prediction methods are limited due to variable parameters and incomplete use of corneal topography data. The study evaluates a deep learning model that predicts vault and creates images of the anterior chamber from preoperative data, helping to personalize surgical planning. The study observes eyes that have undergone ICL surgery performed by experienced surgeons. The corneal tomography generation model analyzes the surgical data to assess its performance in predicting vault, including measures of accuracy, area under the curve (AUC), sensitivity, and specificity. This study is observational and focuses on evaluating this diagnostic model rather than testing a treatment. Participants will have their preoperative corneal topography data collected and analyzed by the model. Researchers will measure the primary outcome of the model's ability to predict vault seven days after surgery, using AUROC (Area Under the Receiver Operating Characteristic curve). Secondary outcomes include sensitivity and specificity of the model's vault prediction. The study involves participants aged 18 to 45 years with stable myopia and healthy corneal endothelium, with no confounding ocular or systemic conditions. Participation duration and follow-up details are based on the postoperative evaluation at day 7.
CONDITIONS
Brief Title
Predictive Performance of a Generative Model for Corneal Tomography After ICL Implantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Stable myopia with less than or equal to 0.50 diopters change per year for 2 years
- Anterior chamber depth (ACD) of at least 2.80 mm
- Intact corneal endothelium with at least 2000 cells per square millimeter
- No confounding ocular or systemic conditions
You will not qualify if you...
- Glaucoma-spectrum disorders or retinal blood vessel diseases
- Prior corneal or intraocular surgery
- Compromised corneal endothelium
- Uncontrolled systemic diseases
- Pregnancy or lactation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 7 days
Participants undergo corneal tomography and related assessments before and after ICL surgery to evaluate the performance of a predictive deep learning model.
1 to 2 visits depending on surgery timing
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Actively Recruiting
Research Team
F
Fu F Gui
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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