Patients Outcomes of a Monofocal Intraocular Lens Designed for Monovision

Completed

• Conditions: Cataract
• Interventions: Device: Intraocular lens

• Registration Number: NCT06528678
• Lead Sponsor: Clinica Baviera

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-30
• Primary Completion: 2023-06-12
• Study Completion: 2023-10-24
• Status Verified: 2024-07
• Study First Submitted: 2024-07-22
• Study First Submitted QC: 2024-07-26
• Last Update Submitted: 2024-07-26
• Study First Posted: 2024-07-30
• Last Update Posted: 2024-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
EMV monovision	Intraocular lens	Cataract surgery with EMV IOL

Primary Outcome Measures

Name	Time	Method
Visual acuity	One month postoperative	Visual acuity was measured using standard clinical charts
Defocus curve	One month postoperative	Defocus curve was measured using standard clinical charts
Patient Satisfaction	One month postoperative	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

Secondary Outcome Measures

Name	Time	Method
Safety of the device	Surgery, first follow-up visit (1-month) and second follow-up visit (6-months)	Safety of the device was measured in terms of the frequency of adverse events related to the device
Quality of vision	One month postoperative	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

Trial Locations

Locations (1)

Clinica Baviera; 🇪🇸 Valencia, Spain