Patients Outcomes of a Monofocal Intraocular Lens Designed for Monovision

NCT06528678 | Completed FDA Device

• 1 other identifier: LIO_EMV21
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cataract

Keywords

IOL; Monovision; Patient satisfaction

Outcome Measures

Primary Outcomes (3)

• Visual acuity

  Visual acuity was measured using standard clinical charts

  One month postoperative

• Defocus curve

  Defocus curve was measured using standard clinical charts

  One month postoperative

• Patient Satisfaction

  Patient satisfaction was measured using the Cataract Assessment Patient Questionnaire 9 Short Form (Catquest 9SF) from 1 to 5, being 1 major difficulties and 5 cannot decide

  One month postoperative

Secondary Outcomes (2)

• Safety of the device

  Surgery, first follow-up visit (1-month) and second follow-up visit (6-months)

• Quality of vision

  One month postoperative

Study Arms (1)

EMV monovision

Cataract surgery with EMV IOL

Device: Intraocular lens

Interventions

Intraocular lens DEVICE

Lens exchange with an intraocular lens

EMV monovision

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent cataract surgery at Clinica Baviera and implanted bilaterally with advanced monofocal intraocular lenses (RayOne EMV) with monovision configuration. The study population will comprise men and women aged 21 years or older and with an preoperative corneal astigmatism \< 1.50 D.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinica Baviera: lead

Study Sites (1)

Clinica Baviera

Valencia, 46004, Spain

Location

Related Publications (1)

• 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.

  PMID: 40524216 DERIVED

MeSH Terms

Conditions

Cataract; Patient Satisfaction

Interventions

Lenses, Intraocular

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies; Prostheses and Implants

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 30, 2024
• Study Start: April 30, 2021
• Primary Completion: June 12, 2023
• Study Completion: October 24, 2023
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)