Visual Adaptation and Quality of Life After Different IOL Implantation Strategies (MMAQ-IOL)
29. Juli 2026 aktualisiert von: 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.
Studienübersicht
Status
Rekrutierung
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Einschreibung (Geschätzt)
264
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Xiangjun Fu, Ph.D.
- Telefonnummer: +86-28-87393999
- E-Mail: 243981469@qq.com
Studienorte
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Chengdu, China
- Rekrutierung
- 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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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
Patients diagnosed with age-related cataracts who underwent phacoemulsification and intraocular lens (IOL) implantation
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
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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.
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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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Subjective Visual Adaptation Score (Multifocal Motor Adaptation Questionnaire, MMAQ)
Zeitfenster: Preoperatively, and postoperatively at 1 week, 1 month, 3 months, and 6 months
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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
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Total High-Order Aberrations (HOAs)
Zeitfenster: Postoperatively at 1 month, 3 months, and 6 months
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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
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Defocus Curve
Zeitfenster: Postoperatively at 1 month, 3 months, and 6 months
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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
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Uncorrected Binocular Distance Visual Acuity (UDBVA)
Zeitfenster: 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
Zeitfenster: 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
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Horizontal Coma
Zeitfenster: Postoperative 1 month, 3 months, and 6 months
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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
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Vertical Coma
Zeitfenster: Postoperative 1 month, 3 months, and 6 months
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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).
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Postoperative 1 month, 3 months, and 6 months
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Total Coma RMS
Zeitfenster: Postoperative 1 month, 3 months, and 6 months
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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).
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Postoperative 1 month, 3 months, and 6 months
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Uncorrected Binocular Intermediate Visual Acuity (UIBVA)
Zeitfenster: Preoperatively, and postoperatively at 1 month, 3 months, and 6 months
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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
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Uncorrected Bincorrected Near Visual Acuity (UNBVA)
Zeitfenster: Preoperatively, and postoperatively at 1 month, 3 months, and 6 months
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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
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Contrast Sensitivity
Zeitfenster: Postoperative 1 month, 3 months, and 6 months
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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
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: Chao Qu, School of Medicine, University of Electronic Science and Technology of China
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. März 2025
Primärer Abschluss (Geschätzt)
31. Oktober 2027
Studienabschluss (Geschätzt)
31. Dezember 2027
Studienanmeldedaten
Zuerst eingereicht
21. Juli 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
29. Juli 2026
Zuerst gepostet (Tatsächlich)
31. Juli 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
31. Juli 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
29. Juli 2026
Zuletzt verifiziert
1. Juli 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- SCCHEC-2024-425
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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