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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular pressure (IOP) | Intraocular pressure (IOP) measured by non-contact tonometer.(mmHg) | Preoperatively, and postoperatively at 1 day, 1 week, 1 month, and 3 months |
| Pupil Diameter | Measuring Pupil Diameter |
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Inclusion Criteria:
Lens Subluxation Unilateral Implantation Group
Inactive Long-standing Anterior Uveitis with Cataract Unilateral Implantation Group
Post-myopic Laser Corneal Surgery with Cataract Unilateral Implantation Group
Aphakia with Insufficient Residual Capsular Support Unilateral Implantation Group
Exclusion Criteria:
Lens Subluxation Unilateral Implantation Group
Inactive Long-standing Anterior Uveitis with Cataract Unilateral Implantation Group
Post-myopic Laser Corneal Surgery with Cataract Unilateral Implantation Group
Aphakia with Insufficient Residual Capsular Support Unilateral Implantation Group
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wen Xu, Phd | Contact | 86+13858185223 | xuwen2003@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Wen Xu, Phd | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital, Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | China |
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| 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. |
|
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 |
| 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 | Dry eye assessment via Tear Film Break-Up Time (TFBUT) | Preoperatively, and postoperatively at1 week, 1 month, and 3 months |
| Fundus assessment | Fundus assessment via fundus photography and macular optical coherence tomography (OCT). | Preoperatively, and postoperatively at 1 week, 1 month, and 3 months |
| Endothelial cell density | Endothelial cell density(%) | Preoperatively and postoperatively 1 month |
| Frequency of using glasses | Frequency ratings for the use of corrective glasses at a distance, medium range, and close range. | Postoperatively at 1 week, 1 month, and 3 months |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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