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RecruitingNCT07740590MMAQ-IOLUpdated Jul 31, 2026

Visual Adaptation and Quality of Life After Different IOL Implantation Strategies

An observational study in Cataract and Aphakia - Lens Capsule Present, sponsored by Sichuan Academy of Medical Sciences. Recruiting at 1 site in China. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-07-31.

Sponsored by Sichuan Academy of Medical Sciences · Observational

From the registry’s dates

  • Started Mar 2025; still recruiting 1 year 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
264
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cataract
  • Aphakia - Lens Capsule Present

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Keywords

  • Intraocular Lenses
  • Multifocal Intraocular Lenses
  • Neuroadaptation
  • Visual Performance
  • Quality of Life
03

In context

Cataract

1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.

This study's planned enrollment of 264 is above the median of 89 across 475 observational studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Sichuan Academy of Medical Sciences is the lead sponsor of 18 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
264 participants (estimated)
Patient registry
No

Groups and cohorts

  • Dual focus + Dual focus group

    Patients undergoing bilateral implantation of dual-focus intraocular lenses in both eyes

    Device: Bilateral Bifocal IOL Implantation

  • 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

  • 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

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.

06

What researchers measure

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 months

Secondary 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 months

  2. 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 months

  3. 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 months

  4. 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 months

  5. 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).

    Time frame: Postoperative 1 month, 3 months, and 6 months

  6. 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).

    Time frame: Postoperative 1 month, 3 months, and 6 months

  7. 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).

    Time frame: Postoperative 1 month, 3 months, and 6 months

  8. 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.

    Time frame: Preoperatively, and postoperatively at 1 month, 3 months, and 6 months

  9. 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.

    Time frame: Preoperatively, and postoperatively at 1 month, 3 months, and 6 months

  10. 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).

    Time frame: Postoperative 1 month, 3 months, and 6 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2025 (actual). Primary completion is estimated for Oct 2027, 31 months after the start.

Of 167 non-industry observational studies under Cataract, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 30. This study's planned 31 months is above that.

Counting every sponsor, half of 234 studies reached it within 16 months; a quarter within 9 and three quarters within 30.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 21, 2026
First posted
Jul 31, 2026
StartActual
Mar 1, 2025
Primary completionEst.
Oct 31, 2027
CompletionEst.
Dec 31, 2027
Last update
Jul 31, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07740590
Lead sponsor
Sichuan Academy of Medical Sciences
Responsible party
ChaoQu (Professor, Department of Ophthalmology, Sichuan Academy of Medical Sciences) — Principal investigator
First posted
Jul 31, 2026
Start date
Mar 1, 2025
Primary completion
Oct 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Jul 31, 2026

Study contacts

Xiangjun Fu, Ph.D.
Contact
243981469@qq.com
+86-28-87393999
Chao Qu
principal investigator · School of Medicine, University of Electronic Science and Technology of China

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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