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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EMV monovision | Cataract surgery with EMV IOL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraocular lens | Device | Lens exchange with an intraocular lens |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Baviera | Valencia | 46004 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40524216 | Derived | 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. |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D007910 | Lenses, Intraocular |
| ID | Term |
|---|---|
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D019736 | Prostheses and Implants |
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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 |
| D001519 |
| Behavior |