Patients Outcomes of a Monofocal Intraocular Lens Designed for Monovision

Clinica Baviera

Status: Completed

Conditions: Cataract

Treatments: Device: Intraocular lens

Study type: Observational

Funder types: Other

Identifiers

NCT06528678

LIO_EMV21

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

51 participants in 1 patient group

EMV monovision

Description:

Cataract surgery with EMV IOL

Treatment:

Device: Intraocular lens