Patients Outcomes of a Monofocal Intraocular Lens Designed for Monovision
NCT ID: NCT06528678
Last Updated: 2024-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
51 participants
OBSERVATIONAL
2021-04-30
2023-10-24
Brief Summary
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Study design: prospective, observational, non-comparative.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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EMV monovision
Cataract surgery with EMV IOL
Intraocular lens
Lens exchange with an intraocular lens
Interventions
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Intraocular lens
Lens exchange with an intraocular lens
Eligibility Criteria
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Inclusion Criteria
* Availability to complete follow-up examinations up to 6 months after surgery
* Cataract for which removal by phacoemulsification and subsequent IOL implantation was planned
* CDVA was expected to be better than 20/30 (+0.18 logMAR) after IOL implantation
* IOL power calculated in the range of +10.0 to +30.0 D
* Corneal astigmatism \< 1.50 D
* Candidate for refractive surgery in monovision configuration
Exclusion Criteria
* Difficulty for cooperation
* Inability to provide informed consent
* Concurrent participation in another investigational drug or device
* History of ocular trauma
* Previous intraocular or corneal surgery
* Presence of ocular pathologies
* Subjects with diagnosed degenerative visual disorders that were predicted to cause future acuity losses to a level of 20/30 or worse
* Subjects who may be expected to require retinal laser treatment
* Other eye condition that in the opinion of the investigator prevents the subject's participation in the study.
* Any other condition that may be contraindicated according to the IOL Instructions for Use.
21 Years
ALL
No
Sponsors
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Clinica Baviera
OTHER
Responsible Party
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Locations
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Clinica Baviera
Valencia, , Spain
Countries
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References
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Llovet-Rausell A, Navalon-Tortosa J, Druchkiv V, Coloma-Bockos J, Moya-Roca J, Llovet-Osuna F. Patient satisfaction and quality of vision after bilateral implantation of enhanced monofocal IOL and mini-monovision: a prospective study. Eye Vis (Lond). 2025 Jun 16;12(1):23. doi: 10.1186/s40662-025-00439-z.
Other Identifiers
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LIO_EMV21
Identifier Type: -
Identifier Source: org_study_id
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