Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT07321756

Evaluating Presbyopia-Correcting IOLs in Complex Cataract Cases With Anterior Segment Abnormalities

Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-01-07

320

Participants Needed

1

Research Sites

215 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of cataract surgery has evolved from simply restoring sight to providing clear and comfortable full-range vision. Traditionally, monofocal IOLs remain the routine choice for special cases with anterior segment abnormalities-such as lens subluxation, cataract with chronic uveitis, post-laser refractive cataract, and aphakia with insufficient capsular support. However, there is a growing demand among these patients for improved visual quality and spectacle independence.Currently, various presbyopia-correcting IOLs offer distinct advantages, providing more personalized options. The introduction and application of intraoperative optical coherence tomography (iOCT) ensures effective intraoperative monitoring. These advances make the precise implantation of presbyopia-correcting IOLs a promising extension to phacoemulsification in complex cataracts with anterior segment abnormalities. Nevertheless, their exact benefits regarding visual quality, safety, and patient satisfaction require systematic evaluation through rigorous prospective studies and long-term follow-up. Under strict perioperative management, this study will employ iOCT to monitor the accurate implantation of presbyopia-correcting IOLs and will assess postoperative visual quality and patient satisfaction.

CONDITIONS

Official Title

Evaluating Presbyopia-Correcting IOLs in Complex Cataract Cases With Anterior Segment Abnormalities

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 to 80 years with lens subluxation, inactive long-standing anterior uveitis with cataract, post-myopic laser corneal surgery with cataract, or aphakia with insufficient capsular support
  • Diagnosed condition meets surgical indications for lens surgery
  • Unilateral implantation planned
  • Informed consent provided
  • Ability to comply with full follow-up visits
  • Kappa angle less than 0.5 mm
  • Total higher-order aberration root mean square (HOA RMS) within central 4-mm corneal zone less than 1 bcm
  • Mesopic natural pupil diameter between 2.5 mm and 5.5 mm depending on group
  • Expected postoperative astigmatism less than or equal to 1.0 diopters
  • Target spherical equivalent between 0.00 D and �b10.75 D
  • Subjective desire to improve full-range visual function
Not Eligible

You will not qualify if you...

  • Coexisting ocular developmental anomalies such as microphthalmos or microcornea
  • Severe or progressive ocular diseases including glaucoma, diabetic retinopathy, macular degeneration, or severe optic nerve disorders
  • Other organic ocular pathologies such as pathologic high myopia with fundus changes, significant pupillary abnormalities, severe corneal disease or scarring, high irregular astigmatism, chronic or active uveitis, severe amblyopia
  • Lens disorders other than subluxation and cataract
  • Intraoperative complications affecting IOL position or outcome such as posterior capsule rupture or iris prolapse
  • History of prior ocular surgery including corneal refractive laser surgery, glaucoma surgery, vitrectomy, or posterior vitrectomy

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Actively Recruiting

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Research Team

W

Wen Xu, Phd

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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