Clinical trial NCT05863247: Ocular Biomarkers for Successful Premium Trifocal Intra-ocular Lenses Implantation
Official title: Ocular Biomarkers for Successful Premium Trifocal Intra-ocular Lenses Implantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Presbyopia
Low Vision
Keywords: cataract
multifocal IOL
Lead sponsor: Hospital dos Lusíadas
Sponsor class: OTHER
First posted: 2023-05-17
Enrollment: 154
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
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).

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.

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.

Primary outcomes:
measure: Correlation between macular ganglion cell thickness and contrast sensitivity in refractive cataract surgery patients - Identifying cutoff values that predict favourable mIOL adaptation
timeFrame: December 2023
measure: HOA detailed profile impact in dysphotopsia incidence after refractive cataract surgery - - Identifying cutoff values that predict favourable mIOL adaptation
timeFrame: December 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: Hospital dos Lusíadas
Study officials:
affiliation: Hospital dos Lusíadas
name: Guilherme Pires, MD
role: PRINCIPAL_INVESTIGATOR
References: