CataractNCT03787576
Evaluating Patient Satisfaction After Cataract Surgery With Multifocal Intraocular Lens
An observational study of Cataract, run by Clínica Rementería at 1 site in Spain.
Trial summary
Multifocal lens allow most patients to be spectacle-free after cataract surgery. Most studies published up-to-date have focused on visual acuity, but not on patient-reported outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Cataract surgery
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2019to 23 Dec 2020
- 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 with bilateral implantation of a multifocal intraocular lens and who are willing to participate in the study.
Who may be able to join
- Previous bilateral cataract surgery
- Bilateral implantation of multifocal intraocular lens
Who cannot join
- Presence of ocular pathologies
- Intra- or postoperative complications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between Patient Satisfaction After Cataract Surgery With Multifocal Intraocular Lens Implantation and Defocus Curves, Contrast Sensitivity and Photic Phenomena
Multifocal lens allow most patients to be spectacle-free after cataract surgery. Most studies published up-to-date have focused on visual acuity, but not on patient-reported outcomes. Since some patients with very good postoperative visual acuity report being very uncomfortable after surgery, the aim of this study is to evaluate if patient satisfaction is correlated with other outcomes, such as low-contrast visual acuity, contrast sensitivity, photic phenomena and ability to tolerate defocus. Patients who have undergone surgery with bilateral multifocal intraocular lens implantation will be carefully evaluated 3 months after surgery to try to determine the factors that correlate with patient reported outcomes as evaluated with the Catquest SF-9 questionnaire.
- Conditions
- Cataract
- Being tested
- Cataract surgery
- Keywords
- Multifocal intraocular lens, Trifocal intraocular lens, Extended Depth of Focus Lens
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cataract surgeryDevice
Evaluation of patient satisfaction after bilateral cataract surgery with multifocal intraocular lens implantation
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Patient satisfaction with visual outcome three months after surgery as evaluated with the Catquest-9 questionnaire
Measured: Three months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start1 Feb 2019
- Primary completion23 Dec 2020
- Study completion23 Dec 2020
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clínica Rementería
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Inés Contreras, Principal investigator, Clinina Rementería
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03787576
- Sponsor's protocol ID
- 18/552-E
- Status last verified
- Jan 2021
- First submitted
- 23 Dec 2018
- Last updated
- 29 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Rementeria-Capelo LA, Contreras I, Garcia-Perez JL, Carrillo V, Gros-Otero J, Ruiz-Alcocer J. Tolerance to Residual Refractive Errors After Trifocal and Trifocal Toric Intraocular Lens Implantation. Eye Contact Lens. 2021 Apr 1;47(4):213-218. doi: 10.1097/ICL.0000000000000726.
PubMed 33323876
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Patient Satisfaction After Cataract Surgery With Multifocal Intraocular Lens Implantation and Defocus Curves, Contrast Sensitivity and Photic Phenomena
- ClinicalTrials.gov ID
- NCT03787576
- Acronym / sponsor ID
- 18/552-E
- Conditions
- Cataract
- Keywords
- Multifocal intraocular lens, Trifocal intraocular lens, Extended Depth of Focus Lens
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Clínica RementeríaUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 23 Dec 2020 (actual)
- Study completion
- 23 Dec 2020 (actual)
- First posted
- 26 Dec 2018 (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.
Multifocal lens allow most patients to be spectacle-free after cataract surgery. Most studies published up-to-date have focused on visual acuity, but not on patient-reported outcomes. Since some patients with very good postoperative visual acuity report being very uncomfortable after surgery, the aim of this study is to evaluate if patient satisfaction is correlated with other outcomes, such as low-contrast visual acuity, contrast sensitivity, photic phenomena and ability to tolerate defocus. Patients who have undergone surgery with bilateral multifocal intraocular lens implantation will be carefully evaluated 3 months after surgery to try to determine the factors that correlate with patient reported outcomes as evaluated with the Catquest SF-9 questionnaire.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
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 with bilateral implantation of a multifocal intraocular lens and who are willing to participate in the study.
Key inclusion criteria (2 listed)
- Previous bilateral cataract surgery
- Bilateral implantation of multifocal intraocular lens
Key exclusion criteria (2 listed)
- Presence of ocular pathologies
- Intra- or postoperative complications
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 surgeryEvaluation of patient satisfaction after bilateral cataract surgery with multifocal intraocular lens implantation | Device | – |
Primary outcome
Patient satisfaction
Time frame: Three months after surgery
Patient satisfaction with visual outcome three months after surgery as evaluated with the Catquest-9 questionnaire
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 29 Jan 2021.
- Results publication: PubMed 33323876Rementeria-Capelo LA, Contreras I, Garcia-Perez JL, Carrillo V, Gros-Otero J, Ruiz-Alcocer J. Tolerance to Residual Refractive Errors After Trifocal and Trifocal Toric Intraocular Lens Implantation. Eye Contact Lens. 2021 Apr 1;47(4):213-218. doi: 10.1097/ICL.0000000000000726.
- Individual participant dataSharing planned: Undecided
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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.
Inés Contreras principal investigator
Clinina Rementería
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 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 2 inclusion and 2 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 29 Jan 2021. 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?
Patient satisfaction (time frame: Three months after surgery). 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 NCT03787576, 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 29 Jan 2021.