Visual Adaptation and Quality of Life After Different IOL Implantation Strategies
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorSichuan Academy of Medical Sciences
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients diagnosed with age-related cataracts who underwent phacoemulsification and intraocular lens (IOL) implantation
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Bilateral Bifocal IOL Implantation
DeviceBilateral phacoemulsification with bifocal intraocular lens implantation in both eyes.
Bifocal and EDOF IOL Mix-and-Match Implantation
DeviceBilateral phacoemulsification with bifocal intraocular lens implantation in one eye and EDOF intraocular lens implantation in the contralateral eye.
Bifocal and Monofocal IOL Mix-and-Match Implantation
DeviceBilateral phacoemulsification with bifocal intraocular lens implantation in one eye and monofocal intraocular lens implantation in the contralateral eye.
Treatment groups
264 Participants
are divided into 3 treatment groupsGroup A: Dual focus + Dual focus group1 intervention
Group B: Dual focus + EDOF group1 intervention
Group C: Dual focus + Single focus group1 intervention
Trial outcomes
Primary outcomes
1
Subjective Visual Adaptation Score (Multifocal Motor Adaptation Questionnaire, MMAQ)
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.
Time frame
Preoperatively, and postoperatively at 1 week, 1 month, 3 months, and 6 monthsSecondary outcomes
1
Total High-Order Aberrations (HOAs)
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).
Time frame
Postoperatively at 1 month, 3 months, and 6 months2
Defocus Curve
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
Time frame
Postoperatively at 1 month, 3 months, and 6 months3
Uncorrected Binocular Distance Visual Acuity (UDBVA)
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.
Time frame
Preoperatively, and postoperatively at ,1 month, 3 months, and 6 months4
Spherical Aberration
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).
Time frame
Postoperative 1 month, 3 months, and 6 monthsSponsors and contacts
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Source ClinicalTrials.gov