Aphakia - Lens Capsule Present, Cataract
Conditions
Keywords
Intraocular Lenses, Multifocal Intraocular Lenses, Neuroadaptation, Visual Performance, Quality of Life
Brief summary
This longitudinal observational study aims to evaluate long-term visual adaptation trajectories, optical quality, and patient-reported outcomes in age-related cataract patients following bilateral implantation of multifocal or mix-and-match intraocular lenses (IOLs). Patients will be followed up longitudinally after surgery to systematically assess visual performance and quality of life.
Detailed description
Multifocal and mix-and-match intraocular lens (IOL) implantation strategies have been widely adopted to restore full-range vision after cataract surgery. However, patients often experience varying rates and trajectories of neuroadaptation to optical phenomena such as glare and halos. This study prospectively observational tracks age-related cataract patients undergoing bilateral IOL implantation (homogeneous or mix-and-match combinations). Postoperative evaluations are systematically conducted across key follow-up time points (ranging from 1 week up to 6 months postoperatively). Primary evaluations involve standard ophthalmological measurements alongside validated visual questionnaires (including the MMAQ) to capture longitudinal adaptation patterns, spectacle independence, and overall visual satisfaction.
Interventions
DEVICEBilateral Bifocal IOL Implantation
Bilateral phacoemulsification with bifocal intraocular lens implantation in both eyes.
DEVICEBifocal and EDOF IOL Mix-and-Match Implantation
Bilateral phacoemulsification with bifocal intraocular lens implantation in one eye and EDOF intraocular lens implantation in the contralateral eye.
DEVICEBifocal and Monofocal IOL Mix-and-Match Implantation
Bilateral phacoemulsification with bifocal intraocular lens implantation in one eye and monofocal intraocular lens implantation in the contralateral eye.
Sponsors
Sichuan Academy of Medical Sciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older with age-related cataract requiring bilateral phacoemulsification and intraocular lens (IOL) implantation * Corneal astigmatism less than 0.75 D * Good general health and willing to complete all postoperative follow-up visits * Signed written informed consent
Exclusion criteria
* Previous ocular surgery or ocular trauma * Coexisting ocular diseases affecting visual potential, such as corneal opacity, glaucoma, macular degeneration, or diabetic retinopathy * Intraoperative or postoperative complications (e.g., posterior capsule rupture) * Systemic diseases that may interfere with visual outcomes or follow-up compliance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Visual Adaptation Score (Multifocal Motor Adaptation Questionnaire, MMAQ) | Preoperatively, and postoperatively at 1 week, 1 month, 3 months, and 6 months | Assessed using the Multifocal Motor Adaptation Questionnaire (MMAQ), a custom-designed questionnaire developed by the research team to measure subjective visual adaptation and symptoms in patients following intraocular lens implantation. Scores range from 0 to 100, with higher scores indicating higher levels of visual adaptation and satisfaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total High-Order Aberrations (HOAs) | Postoperatively at 1 month, 3 months, and 6 months | Change in total high-order aberrations (3rd to 6th order RMS, measured in micrometers) from baseline to 1 month, 3 months, and 6 months postoperatively, evaluated using an ocular/corneal wavefront aberrometer under a standardized pupil diameter (e.g., 4.0 mm / 6.0 mm). |
| Defocus Curve | Postoperatively at 1 month, 3 months, and 6 months | Visual acuity evaluated at varying lens powers ranging from +1.50 D to -4.00 D in 0.50 D steps to assess the range of clear vision |
| Uncorrected Binocular Distance Visual Acuity (UDBVA) | Preoperatively, and postoperatively at ,1 month, 3 months, and 6 months | Change in uncorrected binocular distance visual acuity measured at 4 meters under photopic lighting conditions using standard Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts. Lower LogMAR values indicate superior visual acuity. |
| Spherical Aberration | Postoperative 1 month, 3 months, and 6 months | Change in spherical aberration ( Zernike coefficient, measured in micrometers) from baseline to 1 month, 3 months, and 6 months postoperatively, evaluated using an ocular/corneal wavefront aberrometer under a standardized pupil diameter (e.g., 4.0 mm / 6.0 mm). |
| Horizontal Coma | Postoperative 1 month, 3 months, and 6 months | Change in horizontal coma ( Zernike coefficient, measured in micrometers) from baseline to 1 month, 3 months, and 6 months postoperatively, evaluated using an ocular/corneal wavefront aberrometer under a standardized pupil diameter (e.g., 4.0 mm / 6.0 mm). |
| Vertical Coma | Postoperative 1 month, 3 months, and 6 months | Change in vertical coma Zernike coefficient, measured in micrometers) from baseline to 1 month, 3 months, and 6 months postoperatively, evaluated using an ocular/corneal wavefront aberrometer under a standardized pupil diameter (e.g., 4.0 mm / 6.0 mm). |
| Total Coma RMS | Postoperative 1 month, 3 months, and 6 months | Change in total coma measured in micrometers) from baseline to 1 month, 3 months, and 6 months postoperatively, evaluated using an ocular/corneal wavefront aberrometer under a standardized pupil diameter (e.g., 4.0 mm / 6.0 mm). |
| Uncorrected Binocular Intermediate Visual Acuity (UIBVA) | Preoperatively, and postoperatively at 1 month, 3 months, and 6 months | Change in uncorrected binocular intermediate visual acuity measured at 80 cm (and/or 66 cm) under photopic lighting conditions using standard Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts. Lower LogMAR values indicate superior visual acuity. |
| Uncorrected Bincorrected Near Visual Acuity (UNBVA) | Preoperatively, and postoperatively at 1 month, 3 months, and 6 months | Change in uncorrected binocular near visual acuity measured at 40 cm under photopic lighting conditions ($85\\ \\text{cd/m}\^2$) using standard Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts. Lower LogMAR values indicate superior visual acuity. |
| Contrast Sensitivity | Postoperative 1 month, 3 months, and 6 months | Change in contrast sensitivity (logarithmic values) across standardized spatial frequencies (1.5, 3, 6, 12, and 18 cycles per degree) from baseline to 1 month, 3 months, and 6 months postoperatively. Evaluated using a standardized contrast sensitivity chart (e.g., CSV-1000 or Optec 6500) under both photopic and mesopic lighting conditions (with and without glare). |
Countries
China
Contacts
CONTACTXiangjun Fu, Ph.D.
PRINCIPAL_INVESTIGATORChao Qu
School of Medicine, University of Electronic Science and Technology of China
Outcome results
None listed