Visual Adaptation and Quality of Life After Different IOL Implantation Strategies (MMAQ-IOL)

Evaluation of Visual Adaptation and Optical Performance in Patients With Bilateral Multifocal or Mix-and-Match Intraocular Lens Implantation: A Longitudinal Observational Study

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.

Study Overview

• Status: Recruiting
• Conditions: Cataract; Aphakia - Lens Capsule Present
• Intervention / Treatment: Device: Bilateral Bifocal IOL Implantation; Device: Bifocal and EDOF IOL Mix-and-Match Implantation; Device: Bifocal and Monofocal IOL Mix-and-Match Implantation

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.

• Study Type: Observational
• Enrollment (Estimated): 264

Contacts and Locations

• Study Contact: Name: Xiangjun Fu, Ph.D.; Phone Number: +86-28-87393999; Email: 243981469@qq.com

Study Locations

• China
  • Chengdu, China
    • Recruiting
    • Sichuan Provincial People's Hospital
    • Contact: Xiang Yang,, M.D; Phone Number: +86-28-87393999; Email: xiangyangttt@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with age-related cataracts who underwent phacoemulsification and intraocular lens (IOL) implantation

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Dual focus + Dual focus group; Patients undergoing bilateral implantation of dual-focus intraocular lenses in both eyes	Device: Bilateral Bifocal IOL Implantation; Bilateral phacoemulsification with bifocal intraocular lens implantation in both eyes.
Dual focus + EDOF group; Patients undergoing bilateral implantation of a dual-focus intraocular lens in one eye and an Extended Depth of Focus (EDOF) lens in the contralateral eye	Device: Bifocal 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.
Dual focus + Single focus group; Patients undergoing bilateral implantation of a dual-focus intraocular lens in one eye and a monofocal intraocular lens in the contralateral eye.	Device: Bifocal 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Preoperatively, and postoperatively at 1 week, 1 month, 3 months, and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Postoperatively at 1 month, 3 months, and 6 months
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	Postoperatively at 1 month, 3 months, and 6 months
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.	Preoperatively, and postoperatively at ,1 month, 3 months, and 6 months
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).	Postoperative 1 month, 3 months, and 6 months
Horizontal Coma	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).	Postoperative 1 month, 3 months, and 6 months
Vertical Coma	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).	Postoperative 1 month, 3 months, and 6 months
Total Coma RMS	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).	Postoperative 1 month, 3 months, and 6 months
Uncorrected Binocular Intermediate Visual Acuity (UIBVA)	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.	Preoperatively, and postoperatively at 1 month, 3 months, and 6 months
Uncorrected Bincorrected Near Visual Acuity (UNBVA)	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.	Preoperatively, and postoperatively at 1 month, 3 months, and 6 months
Contrast Sensitivity	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).	Postoperative 1 month, 3 months, and 6 months

Collaborators and Investigators

• Sponsor: Sichuan Academy of Medical Sciences
• Investigators: Principal Investigator: Chao Qu, School of Medicine, University of Electronic Science and Technology of China

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: July 21, 2026
• First Submitted That Met QC Criteria: July 29, 2026
• First Posted (Actual): July 31, 2026

Study Record Updates

• Last Update Posted (Actual): July 31, 2026
• Last Update Submitted That Met QC Criteria: July 29, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Quality of Life; Visual Performance; Multifocal Intraocular Lenses; Neuroadaptation; Intraocular Lenses
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: SCCHEC-2024-425

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No