Lenses, IntraocularNCT04916041
Visual Function in Subjects Implanted With Advanced Technology Intraocular Lenses
An observational study of Lenses, Intraocular, run by Clínica Rementería at 1 site in Spain.
Trial summary
Multiple intraocular lens are nowadays available for implantation after cataract surgery. They use different technology to try to improve patient spectacle independence. It is necessary to better characterise the performence of each type of lens, as well as to define how they are affected by residual refractive… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lenses, Intraocular
- What is being tested?
- Cataract surgery with bilateral implantation of the same type of intraocular lens
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2021to 1 Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have undergone bilateral cataract surgery between three and nine months prior to study procedures, with bilateral implantation of one of the intraocular lens models included in the study
Who may be able to join
None listed.
Who cannot join
- Intrasurgical complications Postsurgical complications Ophthalmological disease that limits visual potential as estimated by investigator
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Clínica Rementería
Madrid, 28010
Inés Contreras, 34913080808, contreras@clinicarementeria.es
About this study
Multiple intraocular lens are nowadays available for implantation after cataract surgery. They use different technology to try to improve patient spectacle independence. It is necessary to better characterise the performence of each type of lens, as well as to define how they are affected by residual refractive errors. The purpose of this study is to evaluate visual function in patients implanted with different lenses (advanced monofocals, trifocals) in order to be able to recommend the best type of lens for each patient.
- Conditions
- Lenses, Intraocular
- Being tested
- Cataract surgery with bilateral implantation of the same type of intraocular lens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cataract surgery with bilateral implantation of the same type of intraocular lensDevice
Cataract surgery with bilateral implantation of the same type of intraocular lens
| Study group | Role | What they receive |
|---|---|---|
| Vivity | Patients who have undergone bilateral implantation of Vivity intraocular lens Receives: Device: Cataract surgery with bilateral implantation of the same type of intraocular lens | |
| Eyhance | Patients who have received bilateral implantation of an Eyhance intraocular lens Receives: Device: Cataract surgery with bilateral implantation of the same type of intraocular lens | |
| EMV | Patients who have undergone bilateral implantation of Vivity intraocular lens Receives: Device: Cataract surgery with bilateral implantation of the same type of intraocular lens | |
| Panoptix | Patients who have undergone bilateral implantation of Panoptix intraocular lens Receives: Device: Cataract surgery with bilateral implantation of the same type of intraocular lens | |
| Rayner Trifocal | Patients who have undergone bilateral implantation of Rayner trifocal intraocular lens Receives: Device: Cataract surgery with bilateral implantation of the same type of intraocular lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intermediate binocular uncorrected visual acuity
Measured: 3-9 months after cataract surgery
Secondary outcomes (5)
Distance binocular uncorrected visual acuity
Measured: 3-9 months after cataract surgery
Near binocular uncorrected visual acuity
Measured: 3-9 months after cataract surgery
Binocular contrast sensitivity
Measured: 3-9 months after cataract surgery
Halo perception
Measured: 3-9 months after cataract surgery
Self-reported visual function questionnaires
Measured: 3-9 months after cataract surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start1 Jun 2021
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lenses, IntraocularStudies 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clínica Rementería
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04916041
- Sponsor's protocol ID
- 21/365-O_P
- Status last verified
- Jul 2022
- First submitted
- 1 Jun 2021
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Function in Subjects Implanted With Advanced Technology Intraocular Lenses
- ClinicalTrials.gov ID
- NCT04916041
- Acronym / sponsor ID
- 21/365-O_P
- Conditions
- Lenses, Intraocular
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Clínica RementeríaUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 7 Jun 2021 (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.
Multiple intraocular lens are nowadays available for implantation after cataract surgery. They use different technology to try to improve patient spectacle independence. It is necessary to better characterise the performence of each type of lens, as well as to define how they are affected by residual refractive errors. The purpose of this study is to evaluate visual function in patients implanted with different lenses (advanced monofocals, trifocals) in order to be able to recommend the best type of lens for each patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Vivity | – | Device: Cataract surgery with bilateral implantation of the same type of intraocular lensPatients who have undergone bilateral implantation of Vivity intraocular lens |
| Eyhance | – | Device: Cataract surgery with bilateral implantation of the same type of intraocular lensPatients who have received bilateral implantation of an Eyhance intraocular lens |
| EMV | – | Device: Cataract surgery with bilateral implantation of the same type of intraocular lensPatients who have undergone bilateral implantation of Vivity intraocular lens |
| Panoptix | – | Device: Cataract surgery with bilateral implantation of the same type of intraocular lensPatients who have undergone bilateral implantation of Panoptix intraocular lens |
| Rayner Trifocal | – | Device: Cataract surgery with bilateral implantation of the same type of intraocular lensPatients who have undergone bilateral implantation of Rayner trifocal intraocular lens |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have undergone bilateral cataract surgery between three and nine months prior to study procedures, with bilateral implantation of one of the intraocular lens models included in the study
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Intrasurgical complications Postsurgical complications Ophthalmological disease that limits visual potential as estimated by investigator
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 |
|---|---|---|
| Cataract surgery with bilateral implantation of the same type of intraocular lensCataract surgery with bilateral implantation of the same type of intraocular lens | Device | EMV, Eyhance, Panoptix, Rayner Trifocal, Vivity |
Primary outcome
Intermediate binocular uncorrected visual acuity
Time frame: 3-9 months after cataract surgery
5 secondary outcomes
Distance binocular uncorrected visual acuity
Time frame: 3-9 months after cataract surgery
Near binocular uncorrected visual acuity
Time frame: 3-9 months after cataract surgery
Binocular contrast sensitivity
Time frame: 3-9 months after cataract surgery
Halo perception
Time frame: 3-9 months after cataract surgery
Self-reported visual function questionnaires
Time frame: 3-9 months after cataract surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- 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.
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 Lenses, Intraocular, run by Clínica Rementería 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 0 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 20 Jul 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intermediate binocular uncorrected visual acuity (time frame: 3-9 months after cataract surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2022.