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

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

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 320 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Academic / other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT07321756 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Hangzhou, Zhejiang

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

Study contacts

• Principal investigator: Wen Xu, Phd — Second Affiliated Hospital, School of Medicine, Zhejiang University
• Study coordinator: Wen Xu, Phd

Conditions Lens Diseases