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Clinical trial Recruiting at 1 site Interventional Ages 18 to 80

Presbyopia-correcting intraocular lenses for complex cataracts with anterior segment abnormalities

Official title: Clinical Study on the Application of Presbyopia-correcting Intraocular Lenses in the Surgery of Cataract Patients With Combined Anterior Segment Structural Abnormalities

Run by Second Affiliated Hospital, Zhejiang University, School of Medicine · NCT07321756 · Data updated 2026-11-12

This trial will test whether presbyopia-correcting intraocular lenses provide better full-range vision and reduce the need for glasses compared with standard monofocal lenses in people having cataract surgery complicated by anterior segment abnormalities.

Quick facts

Study typeInterventional
Ages18 Years to 80 Years
SexAll
Enrollment320 (estimated)
SponsorSecond Affiliated Hospital, Zhejiang University, School of Medicine
Academic / other
Locations1 site (Hangzhou, Zhejiang)
StatusRecruiting
StartedNovember 17, 2025
Main results expectedDecember 31, 2029
Study endsDecember 31, 2029
Registry record updatedJanuary 7, 2026
Trial IDNCT07321756 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18–80 with cataracts and specified anterior segment abnormalities (for example lens subluxation, inactive long‑standing anterior uveitis, post‑refractive cataract, or aphakia with inadequate capsular support) who meet ocular biometric criteria (kappa angle <0.5 mm, central 4‑mm corneal HOA RMS <1 µm, mesopic pupil 3.0–5.5 mm, expected postoperative astigmatism ≤1.0 D) and are willing to undergo unilateral implantation and full follow-up are ideal candidates.

Probably not a fit

Patients with active or recently active uveitis, marked pupil deformity, large kappa angle or high corneal higher‑order aberrations, uncontrolled ocular comorbidities, or those who cannot attend the required follow-up visits are unlikely to benefit from this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective interventional study compares unilateral implantation of presbyopia-correcting posterior chamber IOLs versus standard monofocal IOLs in patients with complex cataracts and anterior segment abnormalities such as lens subluxation, long‑standing inactive anterior uveitis, post‑laser refractive cataract, or aphakia with insufficient capsular support. Surgeons will use precise implantation techniques including intraoperative optical coherence tomography (iOCT) to optimize lens positioning. Outcomes include distance and near visual acuity, optical quality metrics (e.g., higher‑order aberrations), safety events, and patient-reported satisfaction and spectacle dependence measured over postoperative follow-up. Strict ocular inclusion criteria (pupil size, kappa angle, corneal HOA, and expected postoperative astigmatism) are applied and enrollment is unilateral to limit bilateral risk.

Why it matters

Potential benefit: If successful, this approach could expand access to improved full-range vision and greater spectacle independence for patients with cataracts complicated by anterior segment abnormalities while maintaining acceptable safety.

How similar studies have gone: Small case series and limited observational reports have shown promising visual outcomes with presbyopia‑correcting IOLs in select complex cases, but large prospective comparative data remain limited.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Lens Subluxation Unilateral Implantation Group

   * Patients aged 18-80 years with diagnosed lens subluxation meeting surgical indications for lens surgery, enrolled unilaterally;
   * Informed consent for the study;
   * Ability to comply with full follow-up;
   * Kappa angle \<0.5 mm, total higher-order aberration root mean square (HOA RMS) within the central 4-mm corneal zone \<1 μm;
   * Mesopic natural pupil diameter between 3.0 mm and 5.5 mm;
   * Expected postoperative astigmatism ≤1.0 D, with target spherical equivalent between 0.00 D and ±0.75 D;
   * Subjective desire to improve full-range visual function.
2. Inactive Long-standing Anterior Uveitis with Cataract Unilateral Implantation Group

   * Patients aged 18-80 years with diagnosed inactive long-standing anterior uveitis (quiet for ≥3 months) and cataract meeting surgical indications for lens surgery, enrolled unilaterally;
   * Centered pupil without significant deformity, with expected postoperative mesopic natural pupil diameter between 2.5 mm and 5.5 mm;
   * Informed consent for the study;
   * Ability to comply with full follow-up;
   * Kappa angle \<0.5 mm, total higher-order aberration root mean square (HOA RMS) within the central 4-mm corneal zone \<1 μm;
   * Expected postoperative astigmatism ≤1.0 D, with target spherical equivalent between 0.00 D and ±0.75 D;
   * Subjective desire to improve full-range visual function.
3. Post-myopic Laser Corneal Surgery with Cataract Unilateral Implantation Group

   * Patients aged 18-80 years with cataract following prior myopic laser corneal surgery meeting surgical indications for lens surgery, enrolled unilaterally;
   * Informed consent for the study;
   * Ability to comply with full follow-up;
   * Kappa angle \<0.5 mm, total higher-order aberration root mean square (HOA RMS) within the central 4-mm corneal zone \<1 μm;
   * Mesopic natural pupil diameter between 3.0 mm and 5.5 mm;
   * Expected postoperative astigmatism ≤1.0 D, with target spherical equivalent between 0.00 D and ±0.75 D;
   * Subjective desire to improve full-range visual function.
4. Aphakia with Insufficient Residual Capsular Support Unilateral Implantation Group

   * Patients aged 18-80 years with aphakia and insufficient residual capsular support meeting surgical indications for IOL implantation, enrolled unilaterally;
   * Informed consent for the study;
   * Ability to comply with full follow-up;
   * Kappa angle \<0.5 mm, total higher-order aberration root mean square (HOA RMS) within the central 4-mm corneal zone \<1 μm;
   * Mesopic natural pupil diameter between 3.0 mm and 5.5 mm;
   * Expected postoperative astigmatism ≤1.0 D, with target spherical equivalent between 0.00 D and ±0.75 D;
   * Subjective desire to improve full-range visual function.

Exclusion Criteria:

1. Lens Subluxation Unilateral Implantation Group

   * Patients with coexisting ocular developmental anomalies such as microphthalmos or microcornea.
   * Patients with severe or progressive ocular diseases (e.g., glaucoma, diabetic retinopathy, macular degeneration) or severe optic nerve disorders.
   * Patients with other organic ocular pathologies, including pathologic high myopia with fundus changes, significant pupillary abnormalities (excessively large or small pupils), severe corneal disease or scarring, high irregular astigmatism, chronic uveitis, or severe amblyopia.
   * Patients with lens disorders other than subluxation and cataract.
   * Patients experiencing intraoperative complications that may affect IOL position and outcome (e.g., posterior capsule rupture, iris prolapse)
   * Patients with a history of prior ocular surgery such as corneal refractive laser surgery, glaucoma surgery, or vitrectomy.
2. Inactive Long-standing Anterior Uveitis with Cataract Unilateral Implantation Group

   * Patients with active systemic autoimmune diseases, or any systemic disease history or medication use known to significantly affect vision.
   * Patients with coexisting ocular developmental anomalies such as microphthalmos or microcornea.
   * Patients with severe or progressive ocular diseases (e.g., glaucoma, diabetic retinopathy, macular degeneration) or severe optic nerve disorders.
   * Patients with other organic ocular pathologies, including pathologic high myopia with fundus changes, severe corneal disease or scarring, high irregular astigmatism, active uveitis, significant abnormalities of the lens capsule or zonules, or severe amblyopia.
   * Patients experiencing intraoperative complications that may affect IOL position and outcome (e.g., posterior capsule rupture, iris prolapse).
   * Patients with a history of prior ocular surgery such as corneal refractive laser surgery, glaucoma surgery, or vitrectomy.
3. Post-myopic Laser Corneal Surgery with Cataract Unilateral Implantation Group

   * Patients with coexisting ocular developmental anomalies such as microphthalmos or microcornea.
   * Patients with severe or progressive ocular diseases (e.g., glaucoma, diabetic retinopathy, macular degeneration) or severe optic nerve disorders.
   * Patients with other organic ocular pathologies, including pathologic high myopia with fundus changes, significant pupillary abnormalities (excessively large or small pupils), severe corneal disease, high irregular astigmatism, chronic uveitis, significant abnormalities of the lens capsule or zonules, or severe amblyopia.
   * Patients experiencing intraoperative complications that may affect IOL position or outcome (e.g., posterior capsule rupture, iris prolapse).
   * Patients with a history of prior ocular surgery such as glaucoma surgery or vitrectomy.
4. Aphakia with Insufficient Residual Capsular Support Unilateral Implantation Group

   * Patients with coexisting ocular developmental anomalies such as microphthalmos or microcornea.
   * Patients with severe or progressive ocular diseases (e.g., glaucoma, diabetic retinopathy, macular degeneration) or severe optic nerve disorders.
   * Patients with other organic ocular pathologies, including pathologic high myopia with fundus changes, significant pupillary abnormalities (excessively large or small pupils), severe corneal disease or scarring, high irregular astigmatism, chronic uveitis, or severe amblyopia.
   * Patients experiencing intraoperative complications that may affect IOL position or outcome (e.g., iris prolapse).
   * Patients with a history of prior ocular surgery such as corneal refractive laser surgery, glaucoma surgery, or posterior vitrectomy.

Where it's running

  • Second Affiliated Hospital, Zhejiang University School of Medicine
    Hangzhou, Zhejiang, China     Recruiting

Study contacts

  • Principal investigator: Wen Xu, Phd — Second Affiliated Hospital, Zhejiang University, School of Medicine
  • Study coordinator: Wen Xu, Phd
  • Email: xuwen2003@zju.edu.cn
  • Phone: 86+13858185223

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.