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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
320
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.
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.
Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGUncorrected Distance Visual Acuity (UDVA)
Visual acuity measured at distance(at 5m) without correction.
Time frame: 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.
Time frame: 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.)
Time frame: 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.
Time frame: Preoperatively, and postoperatively at 1 month and 3 months
Optical visual quality
Visual symptoms (glare/halos/starburst) assessed via QoV questionnaire
Time frame: Postoperatively at 1 week, 1 month, and 3 months
Visual Function Assessment
Visual Function Index-14 Chinese Version (VF-14-CN) Questionnaire
Time frame: Postoperatively at 1 week, 1 month, and 3 months
Best Corrected Visual Acuity (BCVA)
Best Corrected Visual Acuity at distance (at 5m)
Time frame: Preoperatively, and postoperatively at 1 day, 1 week, 1 month, and 3 months
Uncorrected Intermediate Visual Acuity (UIVA)
Uncorrected visual acuity (UCVA) at intermediate.
Time frame: 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).
Time frame: Preoperatively, and postoperatively at 1 day, 1 week, 1 month, and 3 months
Intraocular pressure (IOP)
Intraocular pressure (IOP) measured by non-contact tonometer.(mmHg)
Time frame: Preoperatively, and postoperatively at 1 day, 1 week, 1 month, and 3 months
Pupil Diameter
Measuring Pupil Diameter
Time frame: Preoperatively, and postoperatively at 1 day, 1 week, 1 month, and 3 months
Ocular B-scan ultrasound
Time frame: Preoperatively, and postoperatively at 1 month and 3 months
Dry Eye Assessment
Dry eye assessment via Tear Film Break-Up Time (TFBUT)
Time frame: Preoperatively, and postoperatively at1 week, 1 month, and 3 months
Fundus assessment
Fundus assessment via fundus photography and macular optical coherence tomography (OCT).
Time frame: Preoperatively, and postoperatively at 1 week, 1 month, and 3 months
Endothelial cell density
Endothelial cell density(%)
Time frame: 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.
Time frame: Postoperatively at 1 week, 1 month, and 3 months
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