CataractNCT04861909
Long-term With a Trifocal Intraocular Lens
An observational study of Cataract, run by Qvision, Ophthalmology Department at 1 site in Spain.
Trial summary
The main aims of this study were to evaluate the patient reported outcomes (PROs), safety and efficacy, after 6-year (66 - 78 months) from the binocular implantation of the AT LISA tri 839MP. A secondary aim was to evaluate new metrics such as contrast sensitivity defocus curves and light distortion analysis. Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- AT LISA tri 839MP
- Type of treatment
- Medical device
- How many people
- 37 participants
- Where
- 1 siteSpain
- Study dates
- 15 Sep 2020to 24 Nov 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 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients implanted with AT Lisa Tri from March 2014 to June 2015
Who may be able to join
- Phone call interview:
- Patients of either sex, 45 years of age or older at the time of surgery and less than 80 years of age at the time of the phone call.
- Patients implanted bilaterally with the AT LISA 839MP MIOL in the capsular bag.
- No surgical complications reported in the clinical history that could affect postoperative visual acuity: damage to the capsular bag, intraocular hemorrhage, etc.
- Operated between 66 months from the first implanted eye and up to 78 months from the surgery of the second eye
- Patient able to hear, understand and give express consent orally.
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- Study visit:
- To have participated in the first stage of the study corresponding to the phone call interview.
- Irregular astigmatism in either eye measured with corneal tomography (total high-order corneal aberrations at 4 mm < 0.5 μm).
- Patient able to read, understand and provide a written informed consent form.
- Sufficient availability, willingness, skills, and cognitive awareness to comply with follow-up/study procedures and study visits.
Who cannot join
- Phone call interview:
- Any eye disease documented in the patient's clinical history that may potentially cause a loss of visual acuity or diplopia: Active or recurrent pathology of the anterior segment (chronic uveitis, iritis, iridocyclitis, rubeosis iridis, uncontrolled glaucoma, etc.), retinal or optic nerve pathologies such as diabetic retinopathy, macular degeneration, etc.
- Eye surgery (including laser refractive surgery) performed before or after the operation with the intraocular lens.
- Study Visit:
- PCO ≥ 2 according to surgeon criteria that produces a loss of CDVA ≥ 0.2 logMAR
- Any eye disorder that can potentially cause a loss of visual acuity or diplopia: Active or recurrent pathology of the anterior segment (chronic uveitis, iritis, iridocyclitis, rubeosis iridis, uncontrolled glaucoma, etc.), retinal or optic nerve pathologies such as diabetic retinopathy, macular degeneration, etc.
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- Eye surgery (including laser refractive surgery) performed before or after the operation with the intraocular lens.
- Use of systemic or ocular medications that may affect vision in the last 6 months.
- Subjects who participate in any clinical trial or research with drugs or medical devices within 30 days prior to entry into this research and/or during the period of participation in this research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Efficacy, Visual Performance and Patient Reported Outcomes With a Trifocal Intraocular Lens: Six-year Follow-up
The main aims of this study were to evaluate the patient reported outcomes (PROs), safety and efficacy, after 6-year (66 - 78 months) from the binocular implantation of the AT LISA tri 839MP. A secondary aim was to evaluate new metrics such as contrast sensitivity defocus curves and light distortion analysis.
Read the detailed description
Retrospective cross-sectional study with two stages:
- Phone call interview:
First stage included patient reported outcomes of visual function, spectacle independence and satisfaction through questionnaires conducted by a phone call in all the patients implanted in our center with AT LISA 839MP from March 2014 to June 2015 (n=92) which accomplished inclusion / exclusion criteria and were able to be contacted by phone (n=62).
The incidence of Nd-YAG capsulotomy was retrospectively evaluated through the revision of the medical history, in patients for which capsulotomy was conducted in our center, or a question, for those treated in another center.
- Study visit:
Second stage included the consecutive invitation of these phone interviewed patients to a visit in our center for a long-term visual performance assessment up to accomplish the required sample size (n=37).
Corrected and uncorrected monocular visual acuities were the primary end-points for testing non-inferiority hypothesis in comparison to 12-month follow-up mean results reported in the literature. Secondary variables of assessment were contrast sensitivity defocus curve and light distortion analysis.
- Conditions
- Cataract
- Being tested
- AT LISA tri 839MP
- Keywords
- Multifocal intraocular lens, Long-term, Safety, Efficacy, Defocus curve, Light distortion
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AT LISA tri 839MPDevice
Non interventional study
| Study group | Role | What they receive |
|---|---|---|
| AT LISA tri 839MP | Patients implanted with AT LISA tri 839MP Receives: Device: AT LISA tri 839MP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monocular visual acuity
Visual acuity measured with and without best corrected distance subjective refraction in logMAR scale, lower value meaning better results.
Measured: 6 years
Secondary outcomes (5)
Contrast sensitivity defocus curve in logCS
Contrast Sensitivity measured at different vergence distances with Multifocal Lens Analyzer (www.defocuscurve.com) in logCS scale, higher value meaning better results.
Measured: 6 years
Light distortion analysis in percentage
Light Distortion Analyzer (CEORLab, University of Minho, Braga, Portugal) in Percentage, higher percentage meaning poorer results.
Measured: 6 years
Visual Function Questionnaire (VF-14)
Patient reported outcomes evaluation of difficulties related to visual function in daily life activities (Scale ranging from 0 - 100, higher values meaning better results)
Measured: 6 years
Patient-Reported Spectacle Independence Questionnaire (PRSIQ)
Patient reported outcomes of spectacle independence showing descriptive results of percentage of patients using need of glasses, often wear and comfortably without wear
Measured: 6 years
Satisfaction, Photic Phenomena and Operated again
Independent questions not associated with a validated questionnaire showing descriptive results of percentage of patients satisfied with their vision, the bothersome to photic phenomena and the likely to be operated again.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start15 Sep 2020
- Primary completion24 Nov 2020
- Study completion24 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qvision, Ophthalmology Department
- Sponsor type
- University, hospital or other
- Collaborators
- Carl Zeiss Meditec AG
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04861909
- Sponsor's protocol ID
- QVI-20-02
- Status last verified
- Apr 2021
- First submitted
- 19 Feb 2021
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Efficacy, Visual Performance and Patient Reported Outcomes With a Trifocal Intraocular Lens: Six-year Follow-up
- ClinicalTrials.gov ID
- NCT04861909
- Acronym / sponsor ID
- QVI-20-02
- Conditions
- Cataract
- Keywords
- Multifocal intraocular lens, Long-term, Safety, Efficacy, Defocus curve, Light distortion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Qvision, Ophthalmology DepartmentUniversity, hospital or other
- Collaborators
- Carl Zeiss Meditec AG
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 24 Nov 2020 (actual)
- Study completion
- 24 Nov 2020 (actual)
- First posted
- 27 Apr 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.
The main aims of this study were to evaluate the patient reported outcomes (PROs), safety and efficacy, after 6-year (66 - 78 months) from the binocular implantation of the AT LISA tri 839MP. A secondary aim was to evaluate new metrics such as contrast sensitivity defocus curves and light distortion analysis.
Detailed description
Retrospective cross-sectional study with two stages:
- Phone call interview:
First stage included patient reported outcomes of visual function, spectacle independence and satisfaction through questionnaires conducted by a phone call in all the patients implanted in our center with AT LISA 839MP from March 2014 to June 2015 (n=92) which accomplished inclusion / exclusion criteria and were able to be contacted by phone (n=62).
The incidence of Nd-YAG capsulotomy was retrospectively evaluated through the revision of the medical history, in patients for which capsulotomy was conducted in our center, or a question, for those treated in another center.
- Study visit:
Second stage included the consecutive invitation of these phone interviewed patients to a visit in our center for a long-term visual performance assessment up to accomplish the required sample size (n=37).
Corrected and uncorrected monocular visual acuities were the primary end-points for testing non-inferiority hypothesis in comparison to 12-month follow-up mean results reported in the literature. Secondary variables of assessment were contrast sensitivity defocus curve and light distortion analysis.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AT LISA tri 839MP | – | Device: AT LISA tri 839MPPatients implanted with AT LISA tri 839MP |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients implanted with AT Lisa Tri from March 2014 to June 2015
Key inclusion criteria (11 listed)
- Phone call interview:
- Study visit:
Key exclusion criteria (9 listed)
- Phone call interview:
- Study Visit:
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 |
|---|---|---|
| AT LISA tri 839MPNon interventional study | Device | AT LISA tri 839MP |
Primary outcome
Monocular visual acuity
Time frame: 6 years
Visual acuity measured with and without best corrected distance subjective refraction in logMAR scale, lower value meaning better results.
5 secondary outcomes
Contrast sensitivity defocus curve in logCS
Time frame: 6 years
Light distortion analysis in percentage
Time frame: 6 years
Visual Function Questionnaire (VF-14)
Time frame: 6 years
Patient-Reported Spectacle Independence Questionnaire (PRSIQ)
Time frame: 6 years
Satisfaction, Photic Phenomena and Operated again
Time frame: 6 years
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 27 Apr 2021.
- 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 Qvision, Ophthalmology Department 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 11 inclusion and 9 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 27 Apr 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?
Monocular visual acuity (time frame: 6 years). 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 27 Apr 2021; AzTrials last refreshed its copy on 30 Oct 2026.