MedTrace Logo

Ocular Biomarkers for Successful Premium Trifocal Intra-ocular Lenses Implantation

NCT05863247 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 154

Last updated 2023-05-19

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Hospital dos Lusíadas

    lead OTHER

Principal Investigators

  • Guilherme Pires, MD · Hospital dos Lusíadas

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2023-09-30
Completion
2023-12-31
FDA Device
Yes

Countries

  • Portugal

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05863247 on ClinicalTrials.gov