Ocular Biomarkers for Successful Premium Trifocal Intra-ocular Lenses Implantation

Active, not recruiting

• Conditions: Low Vision; Presbyopia
• Interventions: Other: Patient Reported Outcomes / Biometric data revision

• Registration Number: NCT05863247
• Lead Sponsor: Hospital dos Lusíadas

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.

Study Timeline

• Study Start: 2023-01-01
• Status Verified: 2023-05
• Study First Submitted: 2023-05-09
• Study First Submitted QC: 2023-05-09
• Study First Posted: 2023-05-17
• Last Update Submitted: 2023-05-17
• Last Update Posted: 2023-05-19
• Primary Completion: 2023-09
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 154

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
pseudophakic patients with post-operative dysphotpsias	Patient Reported Outcomes / Biometric data revision	Patients who report dyshoptsias after bilateral in-the-bag implantation of a trifocal intra-ocular lens (AT LISA 839mp)
pseudophakic patients without post-operative dysphotpsias	Patient Reported Outcomes / Biometric data revision	Patients who don't report dyshoptsias after bilateral in-the-bag implantation of a trifocal intra-ocular lens (AT LISA 839mp)

Primary Outcome Measures

Name	Time	Method
Correlation between macular ganglion cell thickness and contrast sensitivity in refractive cataract surgery patients - Identifying cutoff values that predict favourable mIOL adaptation	December 2023	Evaluate if there is a correlation between macular ganglionar cell complex thickness and post-operative contrast-sensitivity at 6 months post-op
HOA detailed profile impact in dysphotopsia incidence after refractive cataract surgery - - Identifying cutoff values that predict favourable mIOL adaptation	December 2023	Evaluate if specific HOA have a greater impact and association with dysphotopsias under the same IOL platform at 6 months post-op

Trial Locations

Locations (1)

Hospital dos Lusíadas; 🇵🇹 Lisboa, Portugal