Comparison of IOL Formulas in Eyes With PCE≥15µm

NCT07346456 | Completed DMC

• 1 other identifier: 3123315445
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

IOL formulas; posterior corneal elevation; refractive outcomes

Outcome Measures

Primary Outcomes (3)

• absolute SEQ-PE(accuracy)

  the absolute values of SEQ-PE

  From enrollment to the end of treatment at 6 months

• SEQ-PE(trueness)

  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

  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

Interventions

Intraocular lens calculation formulas OTHER

The study evaluates four groups of intraocular lens (IOL) power calculation formulas, totaling 13 distinct formulas, to compare their accuracy in predicting postoperative refractive outcomes in cataract patients. Group 1 - Without PK: Barrett Universal II (BUⅡ), EVO 2.0, Kane, Hill-RBF 3.0, LADAS, Pearl-DGS, and K6, which do not incorporate PK. Group 2 - Measured PK-I: Barrett TK measured (I) and EVO Advanced (I), which use measured PK from IOLMaster 700. Group 3 - Measured PK-P: Barrett TK measured (P) and EVO Advanced (P), which use measured PK from Pentacam AXL. Group 4 - Predicted PK: Barrett TK predicted and Kane KC, which estimate PK through prediction algorithms rather than direct measurement. This observational study does not introduce experimental procedures; all data are collected during routine cataract surgery and postoperative follow-up to determine the comparative accuracy of these formulas

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Xi'an Jiaotong University: lead

Study Sites (1)

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

Xi'an, Shaanxi, China

Location

Study Officials

• Ling Bai

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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ophthalmology resident

Study Record Dates

• First Submitted: January 2, 2026
• First Posted: January 16, 2026
• Study Start: April 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 20, 2025
• Last Updated: January 16, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)