PresbyopiaNCT05863247
Ocular Biomarkers for Successful Premium Trifocal Intra-ocular Lenses Implantation
An observational study of Presbyopia and Low Vision, run by Hospital dos Lusíadas at 1 site in Portugal.
Trial summary
The purpose of this study is to identify ocular biomarkers that can predict the success of phacoemulsification with bilateral AT LISA try 839MP (Carl Zeiss Meditec AG) implantation to achieve satisfactory post-post-operativly spectacle-free vision. Social, biometric and patient reported outcomes will be evaluated. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Presbyopia, Low Vision
- What is being tested?
- Patient Reported Outcomes / Biometric data revision
- How many people
- 154 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jan 2023to Dec 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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Included patients presented with bilateral/unilateral cataract and pretended spectacle-free vision for all distances (far , intermediate and near).
Who may be able to join
- Age ≥ 45 years old with clinical identified bilateral cataracts
- Patients that want to have good vision most of the time without glasses at all distances
- Highest limit of mesopic pupil of 6 mm
- Corneal total higher-order aberration (HOA) ≤ 0.5 μm
- Angle kappa ≤ 0.58 mm
- Absence of cornea ectasia diagnostic criteria.
Who cannot join
- Patients with moderate or severe dry eye syndrome
- Ocular comorbidities such as corneal, retinal or optic nerve disease
- Previous ocular surgeries
- Patients with unreal post-surgical visual expectations
- Patients with known mild cognitive impairment or dementia.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to identify ocular biomarkers that can predict the success of phacoemulsification with bilateral AT LISA try 839MP (Carl Zeiss Meditec AG) implantation to achieve satisfactory post-post-operativly spectacle-free vision. Social, biometric and patient reported outcomes will be evaluated.
Read the detailed description
Pre-operatively all patients were submitted to a comprehensive ophthalmic history and examination including, corneal topography, and aberrometry (Pentacam), biometry (IOLMaster 700, Carl Zeiss Meditec AG, Jena, Germany), specular microscopy (CEM 539, Nidek Co Ltd.), and macular and papillary Optical Coherence Tomography (Cirrus 4000 Hd OCT, Carl Zeiss Meditec AG).
All surgeries were performed by the same surgeon done by standard phacoemulsification with in-the-bag IOL placement. Patients had both eyes operated within a week.
Patients were assessed at day 1, 6, and month 3 after surgery. Six months post-operatively, refraction and slit-lamp examination was performed, and patients asked to complete the patient reported outcome questionnaire that evaluates visual satisfaction, spectacle independence and dysphoptsia like-symptoms.
- Conditions
- Presbyopia, Low Vision
- Being tested
- Patient Reported Outcomes / Biometric data revision
- Keywords
- cataract, multifocal IOL
- Medical subject headings
- Presbyopia, Vision, Low, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Reported Outcomes / Biometric data revisionOther
Also called AT LISA tri 839MP (Carl Zeiss Meditec AG)
Multivariate statistical analysis will be done to identify the reported biomarkers to characterize patients into the following categories: satisfied without dysphotopsias, unsatisfied with dysphotopsias, satisfied with dysphotopsias, unsatisfied without dysphotopsias.Main outcome measures will be photic phenomena at 6 months of follow-up in correlation with the following pre-surgical parameters: macular ganglion cell complex thickness and/or total ocular and corneal higher-order aberrations (coma, trefoil, spherical aberration). Patients with known contributing factors for the development of dysphotopsias (such as residual refractive error, IOL decentration, posterior capsular opacification) will be excluded from the analyzis.
| Study group | Role | What they receive |
|---|---|---|
| pseudophakic patients with post-operative dysphotpsias | Patients who report dyshoptsias after bilateral in-the-bag implantation of a trifocal intra-ocular lens (AT LISA 839mp) Receives: Other: Patient Reported Outcomes / Biometric data revision | |
| pseudophakic patients without post-operative dysphotpsias | Patients who don't report dyshoptsias after bilateral in-the-bag implantation of a trifocal intra-ocular lens (AT LISA 839mp) Receives: Other: Patient Reported Outcomes / Biometric data revision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between macular ganglion cell thickness and contrast sensitivity in refractive cataract surgery patients - Identifying cutoff values that predict favourable mIOL adaptation
Evaluate if there is a correlation between macular ganglionar cell complex thickness and post-operative contrast-sensitivity at 6 months post-op
Measured: December 2023
HOA detailed profile impact in dysphotopsia incidence after refractive cataract surgery - - Identifying cutoff values that predict favourable mIOL adaptation
Evaluate if specific HOA have a greater impact and association with dysphotopsias under the same IOL platform at 6 months post-op
Measured: December 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start1 Jan 2023
- Primary completionSep 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PresbyopiaStudies 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
- Retrospective
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital dos Lusíadas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guilherme Neri Pires, Hospital dos Lusíadas
- Investigators
- Guilherme Pires, MD, Principal investigator, Hospital dos Lusíadas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05863247
- Sponsor's protocol ID
- HdosLusiadas
- Status last verified
- May 2023
- First submitted
- 9 May 2023
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular Biomarkers for Successful Premium Trifocal Intra-ocular Lenses Implantation
- ClinicalTrials.gov ID
- NCT05863247
- Acronym / sponsor ID
- HdosLusiadas
- Conditions
- Presbyopia, Low Vision
- Keywords
- cataract, multifocal IOL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Hospital dos LusíadasUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 17 May 2023 (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 purpose of this study is to identify ocular biomarkers that can predict the success of phacoemulsification with bilateral AT LISA try 839MP (Carl Zeiss Meditec AG) implantation to achieve satisfactory post-post-operativly spectacle-free vision. Social, biometric and patient reported outcomes will be evaluated.
Detailed description
Pre-operatively all patients were submitted to a comprehensive ophthalmic history and examination including, corneal topography, and aberrometry (Pentacam), biometry (IOLMaster 700, Carl Zeiss Meditec AG, Jena, Germany), specular microscopy (CEM 539, Nidek Co Ltd.), and macular and papillary Optical Coherence Tomography (Cirrus 4000 Hd OCT, Carl Zeiss Meditec AG).
All surgeries were performed by the same surgeon done by standard phacoemulsification with in-the-bag IOL placement. Patients had both eyes operated within a week.
Patients were assessed at day 1, 6, and month 3 after surgery. Six months post-operatively, refraction and slit-lamp examination was performed, and patients asked to complete the patient reported outcome questionnaire that evaluates visual satisfaction, spectacle independence and dysphoptsia like-symptoms.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pseudophakic patients with post-operative dysphotpsias | – | Other: Patient Reported Outcomes / Biometric data revisionPatients who report dyshoptsias after bilateral in-the-bag implantation of a trifocal intra-ocular lens (AT LISA 839mp) |
| pseudophakic patients without post-operative dysphotpsias | – | Other: Patient Reported Outcomes / Biometric data revisionPatients who don't report dyshoptsias after bilateral in-the-bag implantation of a trifocal intra-ocular lens (AT LISA 839mp) |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Included patients presented with bilateral/unilateral cataract and pretended spectacle-free vision for all distances (far , intermediate and near).
Key inclusion criteria (6 listed)
- Age ≥ 45 years old with clinical identified bilateral cataracts
- Patients that want to have good vision most of the time without glasses at all distances
- Highest limit of mesopic pupil of 6 mm
- Corneal total higher-order aberration (HOA) ≤ 0.5 μm
- Angle kappa ≤ 0.58 mm
Key exclusion criteria (5 listed)
- Patients with moderate or severe dry eye syndrome
- Ocular comorbidities such as corneal, retinal or optic nerve disease
- Previous ocular surgeries
- Patients with unreal post-surgical visual expectations
- Patients with known mild cognitive impairment or dementia.
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 |
|---|---|---|
| Patient Reported Outcomes / Biometric data revisionAlso: AT LISA tri 839MP (Carl Zeiss Meditec AG)Multivariate statistical analysis will be done to identify the reported biomarkers to characterize patients into the following categories: satisfied without dysphotopsias, unsatisfied with dysphotopsias, satisfied with dysphotopsias, unsatisfied without dysphotopsias.Main outcome measures will be photic phenomena at 6 months of follow-up in correlation with the following pre-surgical parameters: macular ganglion cell complex thickness and/or total ocular and corneal higher-order aberrations (coma, trefoil, spherical aberration). Patients with known contributing factors for the development of dysphotopsias (such as residual refractive error, IOL decentration, posterior capsular opacification) will be excluded from the analyzis. | Other | pseudophakic patients with post-operative dysphotpsias, pseudophakic patients without post-operative dysphotpsias |
Primary outcome
Correlation between macular ganglion cell thickness and contrast sensitivity in refractive cataract surgery patients - Identifying cutoff values that predict favourable mIOL adaptation
Time frame: December 2023
Evaluate if there is a correlation between macular ganglionar cell complex thickness and post-operative contrast-sensitivity at 6 months post-op
HOA detailed profile impact in dysphotopsia incidence after refractive cataract surgery - - Identifying cutoff values that predict favourable mIOL adaptation
Time frame: December 2023
Evaluate if specific HOA have a greater impact and association with dysphotopsias under the same IOL platform at 6 months post-op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- 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.
Guilherme Pires, MD principal investigator
Hospital dos Lusíadas
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 Presbyopia and Low Vision, run by Hospital dos Lusíadas at 1 site in Portugal.
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 6 inclusion and 5 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 19 May 2023. 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 Portugal. 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?
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?
Correlation between macular ganglion cell thickness and contrast sensitivity in refractive cataract surgery patients - Identifying cutoff values that predict favourable mIOL adaptation (time frame: December 2023). The study lists 2 primary outcomes in all. 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 19 May 2023.