Cataract
Conditions
Keywords
IOL, Monovision, Patient satisfaction
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.
Interventions
DEVICEIntraocular lens
Lens exchange with an intraocular lens
Sponsors
Clinica Baviera
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Spain
Outcome results
None listed