CataractNCT06528678
Patients Outcomes of a Monofocal Intraocular Lens Designed for Monovision
An observational study of Cataract, run by Clinica Baviera at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Intraocular lens
- Type of treatment
- Medical device
- How many people
- 51 participants
- Where
- 1 siteSpain
- Study dates
- 30 Apr 2021to 24 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cataract
- Being tested
- Intraocular lens
- Keywords
- IOL, Monovision, Patient satisfaction
- Medical subject headings
- Cataract, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraocular lensDevice
Lens exchange with an intraocular lens
| Study group | Role | What they receive |
|---|---|---|
| EMV monovision | Cataract surgery with EMV IOL Receives: Device: Intraocular lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Visual acuity was measured using standard clinical charts
Measured: One month postoperative
Defocus curve
Defocus curve was measured using standard clinical charts
Measured: 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
Measured: One month postoperative
Secondary outcomes (2)
Safety of the device
Safety of the device was measured in terms of the frequency of adverse events related to the device
Measured: 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
Measured: One month postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start30 Apr 2021
- Primary completion12 Jun 2023
- Study completion24 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Baviera
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06528678
- Sponsor's protocol ID
- LIO_EMV21
- Status last verified
- Jul 2024
- First submitted
- 22 Jul 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 40524216
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Outcomes and Patient Satisfaction Results After Implantation of a Monofocal Intraocular Lens Designed for Monovision
- ClinicalTrials.gov ID
- NCT06528678
- Acronym / sponsor ID
- LIO_EMV21
- Conditions
- Cataract
- Keywords
- IOL, Monovision, Patient satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Clinica BavieraUniversity, hospital or other
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 12 Jun 2023 (actual)
- Study completion
- 24 Oct 2023 (actual)
- First posted
- 30 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EMV monovision | – | Device: Intraocular lensCataract surgery with EMV IOL |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraocular lensLens exchange with an intraocular lens | Device | EMV monovision |
Primary outcome
Visual acuity
Time frame: One month postoperative
Visual acuity was measured using standard clinical charts
Defocus curve
Time frame: One month postoperative
Defocus curve was measured using standard clinical charts
Patient Satisfaction
Time frame: 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
2 secondary outcomes
Safety of the device
Time frame: Surgery, first follow-up visit (1-month) and second follow-up visit (6-months)
Quality of vision
Time frame: One month postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Derived from this study: PubMed 40524216Llovet-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by Clinica Baviera at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (time frame: One month postoperative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06528678, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.