Ocular Biomarkers for Successful Premium Trifocal Intra-ocular Lenses Implantation

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Presbyopia; Low Vision
• Intervention / Treatment: Other: Patient Reported Outcomes / Biometric data revision

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 Type: Observational
• Enrollment (Actual): 154

Contacts and Locations

Study Locations

• Portugal
  • Lisboa, Portugal
    • Hospital dos Lusíadas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Included patients presented with bilateral/unilateral cataract and pretended spectacle-free vision for all distances (far , intermediate and near).

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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)	Other: Patient Reported Outcomes / Biometric data revision; 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 Names: AT LISA tri 839MP (Carl Zeiss Meditec AG)
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)	Other: Patient Reported Outcomes / Biometric data revision; 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 Names: AT LISA tri 839MP (Carl Zeiss Meditec AG)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	December 2023

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between macular ganglion cell thickness and contrast sensitivity in refractive cataract surgery patients	Evaluate if there is a correlation between macular ganglionar cell complex thickness and post-operative contrast-sensitivity at 6 months post-op	December 2023
HOA detailed profile impact in dysphotopsia incidence after refractive cataract surgery	. Evaluate if specific HOA have a greater impact and association with dysphotopsias under the same IOL platform at 6 months post-op	December 2023

Collaborators and Investigators

• Sponsor: Hospital dos Lusíadas
• Investigators: Principal Investigator: Guilherme Pires, MD, Hospital dos Lusíadas

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: May 9, 2023
• First Submitted That Met QC Criteria: May 9, 2023
• First Posted (Actual): May 17, 2023

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 17, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: cataract; multifocal IOL
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Refractive Errors; Vision Disorders; Presbyopia; Vision, Low
• Other Study ID Numbers: HdosLusiadas

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No