Ocular Biomarkers for Successful Premium Trifocal Intra-ocular Lenses Implantation

NCT ID: NCT05863247

Last Updated: 2023-05-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 154 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2023-12-31

Brief 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.

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

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)

Patient Reported Outcomes / Biometric data revision

Intervention Type: OTHER

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.

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)

Patient Reported Outcomes / Biometric data revision

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

AT LISA tri 839MP (Carl Zeiss Meditec AG)

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital dos Lusíadas

OTHER

Sponsor Role: lead

Responsible Party

Guilherme Neri Pires

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guilherme Pires, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital dos Lusíadas

Locations

Hospital dos Lusíadas

Lisbon, , Portugal

Countries

Portugal

Other Identifiers

HdosLusiadas

Identifier Type: -

Identifier Source: org_study_id