Ocular Biomarkers for Successful Premium Trifocal Intra-ocular Lenses Implantation

NCT05863247 | Unknown DMC FDA Device

• 1 other identifier: HdosLusiadas
• Study Type: observational
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Presbyopia; Low Vision

Keywords

cataract; multifocal IOL

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

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

Interventions

Patient Reported Outcomes / Biometric data revision 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.

Also known as: AT LISA tri 839MP (Carl Zeiss Meditec AG)

pseudophakic patients with post-operative dysphotpsias; pseudophakic patients without post-operative dysphotpsias

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital dos Lusíadas: lead

Study Sites (1)

Hospital dos Lusíadas

Lisbon, Portugal

Location

MeSH Terms

Conditions

Presbyopia; Vision, Low; Cataract

Interventions

Patient Reported Outcome Measures

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lens Diseases

Intervention Hierarchy (Ancestors)

Health Care Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Services Research; Health Planning; Health Care Economics and Organizations; Patient Outcome Assessment; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Guilherme Pires, MD

  Hospital dos Lusíadas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: May 17, 2023
• Study Start: January 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 19, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)