Comparison of IOL Formulas in Eyes With PCE≥15µm

NCT ID: NCT07346456

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 102 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2025-09-20

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital of Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Shen Weichen

Ophthalmology resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ling Bai

Role: STUDY_DIRECTOR

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

Locations

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

Xi'an, Shaanxi, China

Countries

China

Other Identifiers

3123315445

Identifier Type: -

Identifier Source: org_study_id