Cataract Removal Clinical Trials

Clinical trials related to Cataract Removal Procedure

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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

‣ 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.

Locations
Other Locations
China
Second Affiliated Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
Contact Information
Primary
Wen Xu, Phd
xuwen2003@zju.edu.cn
86+13858185223
Time Frame
Start Date: 2025-11-17
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 320
Treatments
Experimental: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University

This content was sourced from clinicaltrials.gov

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