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Comparison of IOL Formulas in Eyes With PCE≥15µm

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Xi'an Jiaotong University

Status

Completed

Conditions

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

Treatments

Other: Intraocular lens calculation formulas

Study type

Observational

Funder types

Other

Identifiers

NCT07346456
3123315445

Details and patient eligibility

About

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.

Enrollment

102 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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