研究目的
To investigate visual outcomes, spectacle independence, and patient satisfaction after trifocal intraocular lens implantation.
研究成果
The implantation of the diffractive trifocal intraocular lens (FineVision Micro F) provides good visual outcomes at all distances, high spectacle independence, and high patient satisfaction. A small percentage of patients were dissatisfied due to blurred vision, spectacle dependence, dysphotopsias, or dry eye. It is crucial to manage patient expectations and address causes of dissatisfaction to ensure surgical success.
研究不足
The study is retrospective, includes data from multiple centers and surgeons, has selection biases (excluded cases with complications), incomplete data collection from surveys, uses a non-validated satisfaction questionnaire, and does not include contrast sensitivity or defocus curves in visual quality assessment.
1:Experimental Design and Method Selection:
Retrospective multicentric study analyzing data from bilateral non-sequential lens surgery with implantation of a diffractive trifocal intraocular lens (FineVision Micro F12, PhysIOL). The study followed the principles of the Declaration of Helsinki and was approved by the Medical-Legal Commission of Clínica Baviera.
2:Sample Selection and Data Sources:
Included 5,186 patients (10,372 eyes) who underwent refractive or cataract lensectomy with trifocal IOL implantation, with at least 3 months of follow-up. Exclusion criteria included amblyopia, history of refractive or corneal surgery, corneal disease, endothelial dystrophy, retinal detachment history, neuro-ophthalmic disease, pregnancy/lactation, and intra- or postoperative complications affecting visual or refractive outcomes. Data were obtained from Clínica Baviera's automated central clinical record system.
3:List of Experimental Equipment and Materials:
Equipment included slit lamp, intraocular pressure measurement tools, tear break-up time (T-BUT) assessment, pupillometry, pachymetry, funduscopy, endothelial cell count (SP 3000P; Topcon), optical biometry by interferometry (IOLMaster, Carl Zeiss Meditec AG), immersion ultrasound biometry (Ocuscan RPX; Alcon), corneal topography (Orbscan II, Bausch & Lomb; PENTACAM, Alcon), and ocular computed tomography of the macular area. The IOL used was FineVision Micro F12 (PhysIOL).
4:Experimental Procedures and Operational Workflow:
Surgeries were performed by 48 surgeons in 25 centers using identical protocols, including corneal incision, capsulorhexis, phacoemulsification, IOL implantation in the capsular bag, and intracameral cefuroxime injection. Postoperative treatment included topical antibiotic and steroid combinations. Patients were evaluated at 24 hours, 5-7 days, 1 month, and 3 months post-surgery.
5:Data Analysis Methods:
Descriptive analysis of biometric parameters using means and standard deviations. Statistical calculations were performed with STATA 13 software. Pre- and postoperative results were compared using paired t-tests after normality checks, with p < 0.05 considered significant.
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FineVision Micro F12
Micro F12
PhysIOL
Diffractive trifocal intraocular lens implanted during phacoemulsification surgery to provide vision at multiple distances and reduce spectacle dependence.
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IOLMaster
IOLMaster
Carl Zeiss Meditec AG
Used for optical biometry by interferometry in preoperative evaluation.
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SP 3000P
SP 3000P
Topcon
Used for endothelial cell count in preoperative evaluation.
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Ocuscan RPX
RPX
Alcon
Used for immersion ultrasound biometry in preoperative evaluation.
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Orbscan II
II
Bausch & Lomb
Used for corneal topography in preoperative evaluation.
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PENTACAM
PENTACAM
Alcon
Used for corneal topography in preoperative evaluation.
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Nd-YAG laser
Nd-YAG
Used for posterior capsulotomy to treat posterior capsule opacification.
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STATA 13
13
STATA
Statistical software used for data analysis.
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