Comparison of IOL Formulas in Eyes With PCE≥15µm

January 15, 2026 updated by: Shen Weichen, Second Affiliated Hospital of Xi'an Jiaotong University

Intraocular Lens Power Calculation Formulas in Eyes With Posterior Corneal Elevation ≥15 µm: An Eyetemis-based Comparative Analysis

The goal of this observational study is to evaluate the long-term refractive outcomes of advanced intraocular lens (IOL) power calculation formulas in cataract patients with posterior corneal elevation (PCE ≥ 15 μm).

The main question it aims to answer is:

Do PK-based formulas provide superior refractive accuracy compared with Without-PK-based formulas in patients with elevated posterior corneal surfaces?

Participants undergoing routine cataract surgery will have their biometry measured by both Pentacam AXL and IOLMaster 700, and postoperative refraction will be collected at 1 month, 3 months, and 6 months postoperatively.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

102

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China
        • Department of Ophthalmology, The Second Affiliated Hospital of Xi'an Jiaotong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

From June 2024 to January 2025, patients who visited our hospital, were diagnosed with age-related cataract, and underwent cataract surgery.

Description

Inclusion Criteria:

  • Meeting the indications for cataract surgery, and undergoing Phacoemulsification + IOL implantation performed by the same surgeon.
  • Preoperative biometry performed with IOLMaster 700 and Pentacam AXL, with a posterior corneal elevation greater than 15 μm within the central 5 mm zone on Scheimpflug imaging, and a central corneal thickness > 500 μm.
  • Surgery completed successfully without any intraoperative or postoperative complications.
  • Postoperative subjective refraction performed at 1 month after surgery by the same experienced optometrist.

Exclusion Criteria:

  • Patients with pterygium, corneal diseases, glaucoma, uveitis, or fundus diseases (such as macular edema, retinal detachment), excluding high myopia.
  • History of ocular trauma or previous intraocular surgery.
  • Occurrence of intraoperative or postoperative complications, such as iris injury, posterior capsule rupture, IOL dislocation, vitreous prolapse, or vitreous hemorrhage.
  • Postoperative best corrected visual acuity (BCVA) worse than 0.5.
  • Difference between postoperative subjective refraction and preoperative target refraction greater than 2.00 D.
  • Incomplete measurement data.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
absolute SEQ-PE(accuracy)
Time Frame: From enrollment to the end of treatment at 6 months
the absolute values of SEQ-PE
From enrollment to the end of treatment at 6 months
SEQ-PE(trueness)
Time Frame: From enrollment to the end of treatment at 6 months

Spherical Equivalent Prediction Error

  1. SEQ=Sphere+2Cylinder
  2. PE=Postoperative Manifest SEQ-Predicted SEQ
From enrollment to the end of treatment at 6 months
Precision
Time Frame: From enrollment to the end of treatment at 6 months
Precision refers to the consistency of the prediction errors (PE) of a formula across a study population, indicating how closely the individual prediction errors cluster around the central tendency (e.g., mean or median). A formula with higher precision shows smaller variability in its prediction errors.
From enrollment to the end of treatment at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Xi'an Jiaotong University

Investigators

  • Study Director: Ling Bai, Department of Ophthalmology, The Second Affiliated Hospital of Xi'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Actual)

September 1, 2025

Study Completion (Actual)

September 20, 2025

Study Registration Dates

First Submitted

January 2, 2026

First Submitted That Met QC Criteria

January 15, 2026

First Posted (Estimated)

January 16, 2026

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 3123315445

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on The Comparison of IOL Formulas in Eyes With PCE≥15um Undergoing Cataract Surgery

Clinical Trials on Intraocular lens calculation formulas

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe