CataractMMAQ-IOLNCT07740590
Visual Adaptation and Quality of Life After Different IOL Implantation Strategies
An observational study of Cataract and Aphakia - Lens Capsule Present, run by Sichuan Academy of Medical Sciences at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cataract, Aphakia - Lens Capsule Present
- What is being tested?
- Bilateral Bifocal IOL Implantation, Bifocal and EDOF IOL Mix-and-Match Implantation and Bifocal and Monofocal IOL Mix-and-Match Implantation
- Type of treatment
- Medical device
- How many people
- 264 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with age-related cataracts who underwent phacoemulsification and intraocular lens (IOL) implantation
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sichuan Provincial People's Hospital
Chengdu
Xiang Yang,, M.D, +86-28-87393999, xiangyangttt@126.com
About this study
Official title: 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.
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.
- Conditions
- Cataract, Aphakia - Lens Capsule Present
- Being tested
- Bilateral Bifocal IOL Implantation, Bifocal and EDOF IOL Mix-and-Match Implantation, Bifocal and Monofocal IOL Mix-and-Match Implantation
- Keywords
- Intraocular Lenses, Multifocal Intraocular Lenses, Neuroadaptation, Visual Performance, Quality of Life
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral Bifocal IOL ImplantationDevice
Bilateral phacoemulsification with bifocal intraocular lens implantation in both eyes.
Bifocal and EDOF IOL Mix-and-Match ImplantationDevice
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 ImplantationDevice
Bilateral phacoemulsification with bifocal intraocular lens implantation in one eye and monofocal intraocular lens implantation in the contralateral eye.
| Study group | Role | What they receive |
|---|---|---|
| Dual focus + Dual focus group | Patients undergoing bilateral implantation of dual-focus intraocular lenses in both eyes Receives: 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 Receives: 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. Receives: Device: Bifocal and Monofocal IOL Mix-and-Match Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Preoperatively, and postoperatively at 1 week, 1 month, 3 months, and 6 months
Secondary outcomes (10)
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).
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Postoperative 1 month, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start1 Mar 2025
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ChaoQu, Sichuan Academy of Medical Sciences
- Investigators
- Chao Qu, Principal investigator, School of Medicine, University of Electronic Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07740590
- Sponsor's protocol ID
- SCCHEC-2024-425
- Acronym
- MMAQ-IOL
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Visual Adaptation and Optical Performance in Patients With Bilateral Multifocal or Mix-and-Match Intraocular Lens Implantation: A Longitudinal Observational Study
- ClinicalTrials.gov ID
- NCT07740590
- Acronym / sponsor ID
- MMAQ-IOL / SCCHEC-2024-425
- Conditions
- Cataract, Aphakia - Lens Capsule Present
- Keywords
- Intraocular Lenses, Multifocal Intraocular Lenses, Neuroadaptation, Visual Performance, Quality of Life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Sichuan Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dual focus + Dual focus group | – | Device: Bilateral Bifocal IOL ImplantationPatients undergoing bilateral implantation of dual-focus intraocular lenses in both eyes |
| Dual focus + EDOF group | – | Device: Bifocal and EDOF IOL Mix-and-Match ImplantationPatients undergoing bilateral implantation of a dual-focus intraocular lens in one eye and an Extended Depth of Focus (EDOF) lens in the contralateral eye |
| Dual focus + Single focus group | – | Device: Bifocal and Monofocal IOL Mix-and-Match ImplantationPatients undergoing bilateral implantation of a dual-focus intraocular lens in one eye and a monofocal intraocular lens in the contralateral eye. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with age-related cataracts who underwent phacoemulsification and intraocular lens (IOL) implantation
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral Bifocal IOL ImplantationBilateral phacoemulsification with bifocal intraocular lens implantation in both eyes. | Device | Dual focus + Dual focus group |
| Bifocal and EDOF IOL Mix-and-Match ImplantationBilateral phacoemulsification with bifocal intraocular lens implantation in one eye and EDOF intraocular lens implantation in the contralateral eye. | Device | Dual focus + EDOF group |
| Bifocal and Monofocal IOL Mix-and-Match ImplantationBilateral phacoemulsification with bifocal intraocular lens implantation in one eye and monofocal intraocular lens implantation in the contralateral eye. | Device | Dual focus + Single focus group |
Primary outcome
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.
10 secondary outcomes
Total High-Order Aberrations (HOAs)
Time frame: Postoperatively at 1 month, 3 months, and 6 months
Defocus Curve
Time frame: Postoperatively at 1 month, 3 months, and 6 months
Uncorrected Binocular Distance Visual Acuity (UDBVA)
Time frame: Preoperatively, and postoperatively at ,1 month, 3 months, and 6 months
Spherical Aberration
Time frame: Postoperative 1 month, 3 months, and 6 months
Horizontal Coma
Time frame: Postoperative 1 month, 3 months, and 6 months
Vertical Coma
Time frame: Postoperative 1 month, 3 months, and 6 months
Total Coma RMS
Time frame: Postoperative 1 month, 3 months, and 6 months
Uncorrected Binocular Intermediate Visual Acuity (UIBVA)
Time frame: Preoperatively, and postoperatively at 1 month, 3 months, and 6 months
Uncorrected Bincorrected Near Visual Acuity (UNBVA)
Time frame: Preoperatively, and postoperatively at 1 month, 3 months, and 6 months
Contrast Sensitivity
Time frame: Postoperative 1 month, 3 months, and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chao Qu principal investigator
School of Medicine, University of Electronic Science and Technology of China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract and Aphakia - Lens Capsule Present, run by Sichuan Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiangjun Fu, Ph.D. (+86-28-87393999, 243981469@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Visual Adaptation Score (Multifocal Motor Adaptation Questionnaire, MMAQ) (time frame: Preoperatively, and postoperatively at 1 week, 1 month, 3 months, and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.