Ocular Biomarkers for Successful Premium Trifocal Intra-ocular Lenses Implantation

Hospital dos Lusíadas

Status: Active, not recruiting

Conditions: Low Vision; Presbyopia

Treatments: Other: Patient Reported Outcomes / Biometric data revision

Study type: Observational

Funder types: Other

Identifiers

NCT05863247

HdosLusiadas

Details and patient eligibility

About

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.

Full 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.

Enrollment: 154 patients

Sex: All

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

154 participants in 2 patient groups

pseudophakic patients with post-operative dysphotpsias

Description:

Patients who report dyshoptsias after bilateral in-the-bag implantation of a trifocal intra-ocular lens (AT LISA 839mp)

Treatment:

Other: Patient Reported Outcomes / Biometric data revision

pseudophakic patients without post-operative dysphotpsias

Description:

Patients who don't report dyshoptsias after bilateral in-the-bag implantation of a trifocal intra-ocular lens (AT LISA 839mp)

Treatment:

Other: Patient Reported Outcomes / Biometric data revision