Visual Adaptation and Quality of Life After Different IOL Implantation Strategies (MMAQ-IOL)
29. juli 2026 opdateret af: ChaoQu, Sichuan Academy of Medical Sciences
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.
Studieoversigt
Status
Rekruttering
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
264
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Xiangjun Fu, Ph.D.
- Telefonnummer: +86-28-87393999
- E-mail: 243981469@qq.com
Studiesteder
-
-
-
Chengdu, Kina
- Rekruttering
- Sichuan Provincial People's Hospital
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Kontakt:
- Xiang Yang,, M.D
- Telefonnummer: +86-28-87393999
- E-mail: xiangyangttt@126.com
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients diagnosed with age-related cataracts who underwent phacoemulsification and intraocular lens (IOL) implantation
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Dual focus + Dual focus group
Patients undergoing bilateral implantation of dual-focus intraocular lenses in both eyes
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Bilateral phacoemulsification with bifocal intraocular lens implantation in both eyes.
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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
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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.
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Bilateral phacoemulsification with bifocal intraocular lens implantation in one eye and monofocal intraocular lens implantation in the contralateral eye.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Subjective Visual Adaptation Score (Multifocal Motor Adaptation Questionnaire, MMAQ)
Tidsramme: 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.
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Preoperatively, and postoperatively at 1 week, 1 month, 3 months, and 6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Total High-Order Aberrations (HOAs)
Tidsramme: 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).
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Postoperatively at 1 month, 3 months, and 6 months
|
|
Defocus Curve
Tidsramme: 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
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Postoperatively at 1 month, 3 months, and 6 months
|
|
Uncorrected Binocular Distance Visual Acuity (UDBVA)
Tidsramme: Preoperatively, and postoperatively at ,1 month, 3 months, and 6 months
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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.
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Preoperatively, and postoperatively at ,1 month, 3 months, and 6 months
|
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Spherical Aberration
Tidsramme: Postoperative 1 month, 3 months, and 6 months
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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).
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Postoperative 1 month, 3 months, and 6 months
|
|
Horizontal Coma
Tidsramme: 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).
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Postoperative 1 month, 3 months, and 6 months
|
|
Vertical Coma
Tidsramme: 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).
|
Postoperative 1 month, 3 months, and 6 months
|
|
Total Coma RMS
Tidsramme: 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).
|
Postoperative 1 month, 3 months, and 6 months
|
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Uncorrected Binocular Intermediate Visual Acuity (UIBVA)
Tidsramme: 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.
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Preoperatively, and postoperatively at 1 month, 3 months, and 6 months
|
|
Uncorrected Bincorrected Near Visual Acuity (UNBVA)
Tidsramme: 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.
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Preoperatively, and postoperatively at 1 month, 3 months, and 6 months
|
|
Contrast Sensitivity
Tidsramme: 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).
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Postoperative 1 month, 3 months, and 6 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Chao Qu, School of Medicine, University of Electronic Science and Technology of China
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. marts 2025
Primær færdiggørelse (Anslået)
31. oktober 2027
Studieafslutning (Anslået)
31. december 2027
Datoer for studieregistrering
Først indsendt
21. juli 2026
Først indsendt, der opfyldte QC-kriterier
29. juli 2026
Først opslået (Faktiske)
31. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
31. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SCCHEC-2024-425
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