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

Recruiting now · Not applicable

Conditions studied: Lens Diseases

In brief

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.

Key facts

Study ID

NCT07321756

Run by

Second Affiliated Hospital, Zhejiang University, School of Medicine

People needed

320

Starts

2025-11-17

Expected to finish

2029-12-31

Last updated by the study team

2026-01-07

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.
• 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.
• Aphakia with Insufficient Residual Capsular Support Unilateral Implantation Group

You may not qualify if…

• 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.
• 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.
• 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.
• 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).

Where it is running

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

Full record on ClinicalTrials.gov

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