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

NCT07321756 | Recruiting

• 1 other identifier: 2025-1077
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Lens Diseases

Outcome Measures

Primary Outcomes (9)

• Uncorrected Distance Visual Acuity (UDVA)

  Visual acuity measured at distance（at 5m) without correction.

  Preoperatively, and postoperatively at 1 day, 1 week, 1 month, and 3 months.

• Effective Lens Position (ELP)

  ELP determined by IOLMaster 700, anterior segment optical coherence tomography (AS-OCT), and anterior segment photography.

  Baseline, and postoperatively at 1 month, and 3 months

• Contrast sensitivity (at 2.5 m)

  Uncorrected binocular contrast sensitivity was recorded under mesopic, mesopic with glare, photopic, and photopic with glare conditions at spatial frequencies of 3, 6, 12, and 19 cpd.）

  Preoperatively, and postoperatively at 1 week, 1 month, and 3 months

• Defocus curve (at 5 m)

  Defocus curves were obtained monocularly and binocularly under uncorrected vision with a micro-monovision setup. Acuity was recorded across 13 refractive intervals from +2.00 D to -4.00 D in 0.50 D decrements.

  Preoperatively, and postoperatively at 1 month and 3 months

• Optical visual quality

  Visual symptoms (glare/halos/starburst) assessed via QoV questionnaire

  Postoperatively at 1 week, 1 month, and 3 months

• Visual Function Assessment

  Visual Function Index-14 Chinese Version (VF-14-CN) Questionnaire

  Postoperatively at 1 week, 1 month, and 3 months

• Best Corrected Visual Acuity (BCVA)

  Best Corrected Visual Acuity at distance (at 5m)

  Preoperatively, and postoperatively at 1 day, 1 week, 1 month, and 3 months

• Uncorrected Intermediate Visual Acuity (UIVA)

  Uncorrected visual acuity (UCVA) at intermediate.

  Preoperatively, and postoperatively at 1 day, 1 week, 1 month, and 3 months

• Uncorrected Near Visual Acuity (UNVA)

  Uncorrected visual acuity (UCVA) at near (at 40 cm).

  Preoperatively, and postoperatively at 1 day, 1 week, 1 month, and 3 months

Secondary Outcomes (7)

• Intraocular pressure (IOP)

  Preoperatively, and postoperatively at 1 day, 1 week, 1 month, and 3 months

• Pupil Diameter

  Preoperatively, and postoperatively at 1 day, 1 week, 1 month, and 3 months

• Ocular B-scan ultrasound

  Preoperatively, and postoperatively at 1 month and 3 months

• Dry Eye Assessment

  Preoperatively, and postoperatively at1 week, 1 month, and 3 months

• Fundus assessment

  Preoperatively, and postoperatively at 1 week, 1 month, and 3 months

Study Arms (2)

Unilateral Posterior Chamber Presbyopia-Correcting IOL Implantation Group

EXPERIMENTAL

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.

Procedure: Unilateral Posterior Chamber Implantation of Presbyopia-Correcting IOL

Unilateral Posterior Chamber Monofocal IOL Implantation Group

ACTIVE COMPARATOR

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.

Procedure: Unilateral Posterior Chamber Implantation of Monofocal IOL

Interventions

Unilateral Posterior Chamber Implantation of Presbyopia-Correcting IOL 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 Presbyopia-Correcting IOL Implantation Group

Unilateral Posterior Chamber Implantation of Monofocal IOL 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.

Unilateral Posterior Chamber Monofocal IOL Implantation Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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;

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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Lens Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Wen Xu, Phd

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wen Xu, Phd

CONTACT

86+13858185223; xuwen2003@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: January 7, 2026
• Study Start: November 17, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)