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NCT Number: NCT07740590

Visual Adaptation and Quality of Life After Different IOL Implantation Strategies

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.

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Key information

Conditions

Cataract Aphakia - Lens Capsule Present Eye Diseases Lens Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bilateral Bifocal IOL Implantation

Device

Bilateral phacoemulsification with bifocal intraocular lens implantation in both eyes.

Bifocal and EDOF IOL Mix-and-Match Implantation

Device

Bilateral 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

Device

Bilateral phacoemulsification with bifocal intraocular lens implantation in one eye and monofocal intraocular lens implantation in the contralateral eye.

Primary outcomes

  1. Subjective Visual Adaptation Score (Multifocal Motor Adaptation Questionnaire, MMAQ)

    Time frame: 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 outcomes

  1. Total High-Order Aberrations (HOAs)

    Time frame: 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).

  2. Defocus Curve

    Time frame: 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

  3. Uncorrected Binocular Distance Visual Acuity (UDBVA)

    Time frame: 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.

  4. Spherical Aberration

    Time frame: 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).

  5. Horizontal Coma

    Time frame: 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).

  6. Vertical Coma

    Time frame: 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).

  7. Total Coma RMS

    Time frame: 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).

  8. Uncorrected Binocular Intermediate Visual Acuity (UIBVA)

    Time frame: 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.

  9. Uncorrected Bincorrected Near Visual Acuity (UNBVA)

    Time frame: 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.

  10. Contrast Sensitivity

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Xiangjun Fu, Ph.D.

CONTACT

[email protected]

+86-28-87393999

Sponsors and collaborators

Lead sponsor

Sichuan Academy of Medical Sciences

Other

Registry information

Official study title

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

Acronym: MMAQ-IOL

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 31, 2026
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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