Patients Outcomes of a Monofocal Intraocular Lens Designed for Monovision

NCT ID: NCT06528678

Last Updated: 2024-07-30

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-30

Study Completion Date

2023-10-24

Brief Summary

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The rationale for this observational study of a CE-marked lens is to prospectively assess the performance, safety, and patient satisfaction in a group of subjects undergoing cataract surgery with bilateral implantation of the RayOne EMV in a monovision configuration. In order to increase the evidence collected from real-world clinical data we are running a multicentre clinical study in several clinics of the Baviera Ophthalmological Group.

Study design: prospective, observational, non-comparative.

Detailed Description

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Conditions

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Cataract

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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EMV monovision

Cataract surgery with EMV IOL

Intraocular lens

Intervention Type DEVICE

Lens exchange with an intraocular lens

Interventions

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Intraocular lens

Lens exchange with an intraocular lens

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent
* 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

* Women who were pregnant, nursing or planning to become pregnant during the study
* 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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinica Baviera

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinica Baviera

Valencia, , Spain

Site Status

Countries

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Spain

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.

Reference Type DERIVED
PMID: 40524216 (View on PubMed)

Other Identifiers

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LIO_EMV21

Identifier Type: -

Identifier Source: org_study_id

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