NCT05863247

Ocular Biomarkers for Successful Premium Trifocal Intra-ocular Lenses Implantation

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 154 (actual)
• Sponsor: Hospital dos Lusíadas · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-01-01
• Primary completion: 2023-09-01
• Completion: 2023-12-01
• First posted: 2023-05-17
• Last updated: 2023-05-19

Locations

1 site across 1 country: Portugal

Regulatory

• FDA-regulated device study