NCT07346456

Comparison of IOL Formulas in Eyes With PCE≥15µm

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 102 (actual)
• Sponsor: Second Affiliated Hospital of Xi'an Jiaotong University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Intraocular lens calculation formulas	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

Timeline

• Start date: 2025-04-01
• Primary completion: 2025-09-01
• Completion: 2025-09-20
• First posted: 2026-01-16
• Last updated: 2026-01-16

Locations

1 site across 1 country: China