Ocular Biomarkers for Successful Premium Trifocal Intra-ocular Lenses Implantation

Presbyopia Clinical Trial

Official title:

Ocular Biomarkers for Successful Premium Trifocal Intra-ocular Lenses Implantation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05863247
• Other study ID #: HdosLusiadas
• Status: Active, not recruiting
• Start date: January 1, 2023
• Est. completion date: December 2023

Study information

• Verified date: May 2023
• Source: Hospital dos Lusíadas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 154
• Est. completion date: December 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Low Vision
• Presbyopia
• Vision, Low

Intervention

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.

Locations

Country	Name	City	State
Portugal	Hospital dos Lusíadas	Lisboa

Sponsors (1)

Lead Sponsor	Collaborator
Hospital dos Lusíadas

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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