Patients Outcomes of a Monofocal Intraocular Lens Designed for Monovision

Visual Outcomes and Patient Satisfaction Results After Implantation of a Monofocal Intraocular Lens Designed for Monovision

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.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: Intraocular lens

• Study Type: Observational
• Enrollment (Actual): 51

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46004
    • Clinica Baviera

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
EMV monovision; Cataract surgery with EMV IOL	Device: Intraocular lens; Lens exchange with an intraocular lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of the device	Safety of the device was measured in terms of the frequency of adverse events related to the device	Surgery, first follow-up visit (1-month) and second follow-up visit (6-months)
Quality of vision	Quality of vision was measured using a self-administered questionnaire developed at Clinica Baviera to assess patient satisfaction regarding night vision, from 1 to 4 being 1 the maximun score and 4 the worst score	One month postoperative

Collaborators and Investigators

• Sponsor: Clinica Baviera

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2021
• Primary Completion (Actual): June 12, 2023
• Study Completion (Actual): October 24, 2023

Study Registration Dates

• First Submitted: July 22, 2024
• First Submitted That Met QC Criteria: July 26, 2024
• First Posted (Actual): July 30, 2024

Study Record Updates

• Last Update Posted (Actual): July 30, 2024
• Last Update Submitted That Met QC Criteria: July 26, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Patient satisfaction; IOL; Monovision
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: LIO_EMV21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No