Clinical trial NCT06528678: Patients Outcomes of a Monofocal Intraocular Lens Designed for Monovision
Official title: Visual Outcomes and Patient Satisfaction Results After Implantation of a Monofocal Intraocular Lens Designed for Monovision
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Keywords: IOL
Monovision
Patient satisfaction
Lead sponsor: Clinica Baviera
Sponsor class: OTHER
First posted: 2024-07-30
Enrollment: 51
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Visual acuity
timeFrame: One month postoperative
measure: Defocus curve
timeFrame: One month postoperative
measure: Patient Satisfaction
timeFrame: One month postoperative
Secondary outcomes:
measure: Safety of the device
timeFrame: Surgery, first follow-up visit (1-month) and second follow-up visit (6-months)
measure: Quality of vision
timeFrame: One month postoperative
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Clinica Baviera
Study officials:
References: