- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07740590
Visual Adaptation and Quality of Life After Different IOL Implantation Strategies (MMAQ-IOL)
Evaluation of Visual Adaptation and Optical Performance in Patients With Bilateral Multifocal or Mix-and-Match Intraocular Lens Implantation: A Longitudinal Observational Study
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Xiangjun Fu, Ph.D.
- 전화번호: +86-28-87393999
- 이메일: 243981469@qq.com
연구 장소
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Chengdu, 중국
- 모병
- Sichuan Provincial People's Hospital
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연락하다:
- Xiang Yang,, M.D
- 전화번호: +86-28-87393999
- 이메일: xiangyangttt@126.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Subjective Visual Adaptation Score (Multifocal Motor Adaptation Questionnaire, MMAQ)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Total High-Order Aberrations (HOAs)
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Chao Qu, School of Medicine, University of Electronic Science and Technology of China
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
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추가 정보
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