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

NCT ID: NCT07321756

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-17
• Study Completion Date: 2029-12-31

Brief Summary

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.

Detailed Description

With the evolution of refractive cataract surgery, the goal of treatment has progressed from simple visual rehabilitation to providing clear and comfortable full-range vision through the implantation of functional intraocular lenses (IOLs). Traditionally, monofocal IOLs have been the standard choice for patients with anterior segment abnormalities-such as lens subluxation, cataract with a history of chronic anterior uveitis, post-laser refractive surgery cataract, or aphakia with insufficient capsular support-to minimize adverse optical outcomes. However, these patients, who span a broad age range, increasingly desire high postoperative visual quality and reduced spectacle dependence. Modern presbyopia-correcting IOLs offer advantages in material properties, structural design, and optical performance, improving biocompatibility and reducing visual disturbances such as glare and halos, thereby expanding personalized options. The integration of intraoperative optical coherence tomography (iOCT) further enhances the precision and safety of IOL implantation.

Based on these advancements, the precise implantation of presbyopia-correcting IOLs holds promise for complex cataract cases with anterior segment abnormalities. Nevertheless, their efficacy, safety, and impact on patient satisfaction require systematic evaluation through well-designed prospective studies. This prospective study aims to assess the clinical outcomes of precisely implanted presbyopia-correcting IOLs in patients with complex cataract and anterior segment structural abnormalities, including lens subluxation, chronic anterior uveitis, post-refractive surgery status, and aphakia with inadequate capsular support. Utilizing iOCT for real-time monitoring of anterior segment anatomy, capsular stability, and effective lens position (ELP) during surgery, the study will compare visual quality, safety parameters, and patient satisfaction between presbyopia-correcting IOLs and conventional monofocal IOLs, providing evidence to support individualized IOL selection in this population.

Conditions

Lens Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Unilateral Posterior Chamber Presbyopia-Correcting IOL Implantation Group

This arm includes four cohorts of cataract patients with different types of anterior segment structural abnormalities: the lens subluxation group, the chronic anterior uveitis with cataract group, the post-myopic laser corneal surgery with cataract group, and the aphakia with insufficient capsular support group. Patients in each group will undergo unilateral posterior chamber implantation of a suitable type of presbyopia-correcting IOL based on their individual characteristics.

Group Type: EXPERIMENTAL

Unilateral Posterior Chamber Implantation of Presbyopia-Correcting IOL

Intervention Type: PROCEDURE

Based on the specific characteristics and needs of each of the four patient groups, a suitable presbyopia-correcting IOL will be selected and precisely implanted unilaterally in the posterior chamber.

Unilateral Posterior Chamber Monofocal IOL Implantation Group

This arm includes four cohorts of cataract patients with different types of anterior segment structural abnormalities: the lens subluxation group, the chronic anterior uveitis with cataract group, the post-myopic laser corneal surgery with cataract group, and the aphakia with insufficient capsular support group. Patients in each control group will undergo unilateral posterior chamber implantation of a monofocal IOL of the same brand as that used in the experimental group.

Group Type: ACTIVE_COMPARATOR

Unilateral Posterior Chamber Implantation of Monofocal IOL

Intervention Type: PROCEDURE

Each control group will undergo unilateral posterior chamber implantation of the same-brand monofocal IOL as used in the experimental group, following conventional selection criteria.

Interventions

Unilateral Posterior Chamber Implantation of Presbyopia-Correcting IOL

Based on the specific characteristics and needs of each of the four patient groups, a suitable presbyopia-correcting IOL will be selected and precisely implanted unilaterally in the posterior chamber.

Intervention Type: PROCEDURE

Unilateral Posterior Chamber Implantation of Monofocal IOL

Each control group will undergo unilateral posterior chamber implantation of the same-brand monofocal IOL as used in the experimental group, following conventional selection criteria.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wen Xu, Phd

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Locations

Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wen Xu, Phd

Role: CONTACT

xuwen2003@zju.edu.cn

86+13858185223

Facility Contacts

Wen Xu, Phd

Role: primary

xuwen2003@zju.edu.cn

86+ 13858185223

Other Identifiers

2025-1077

Identifier Type: -

Identifier Source: org_study_id