Evidence map›Paper›PMID 39901127›Full record

Trial reportBMC ophthalmology2025

Visual, clinical and quality of life outcomes of a new multifocal IOL with optimized diffractive grating: a non-randomized clinical trial.

João Marcelo de Almeida Gusmão Lyra, Mariana Silva Gois de Almeida, Lucila de Albuquerque Barbosa Lira, Laís Oliveira Dos Santos, Mateus Lins Dos Santos, Jorge Artur Peçanha de Miranda Coelho

Abstract readClinical Trial
In one paragraph

Trial report in BMC ophthalmology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Observational
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

João Marcelo de Almeida Gusmão LyraFundação João Carlos Lyra, Maceió, AL, Brazil. joaomlyra@gmail.com.
Mariana Silva Gois de AlmeidaFundação João Carlos Lyra, Maceió, AL, Brazil.
Lucila de Albuquerque Barbosa LiraFundação João Carlos Lyra, Maceió, AL, Brazil.
Laís Oliveira Dos SantosFundação João Carlos Lyra, Maceió, AL, Brazil.
Mateus Lins Dos SantosHospital de Olhos de Sergipe, Aracaju, SE, Brazil.
Jorge Artur Peçanha de Miranda CoelhoUniversidade Federal de Alagoas, Maceió, AL, Brazil.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMultifocal intraocular lenses (IOLs) are designed to reduce dependence on spectacles by providing multiple focal points. However, they are associated with photic phenomena such as halos and glare, and may reduce contrast sensitivity. The BIOS Trifocal is a single-piece acrylic diffractive IOL with a closed-loop haptic design, optimized for centration and stability. It features an aspheric, aberration-neutral surface and a precisely engineered diffraction grating for effective energy distribution across multiple distances. This study aims to evaluate the visual, clinical, and quality of life outcomes of the BIOS Trifocal IOL for treatment of cataract and presbyopia.

methodsParticipants who met the inclusion criteria underwent implantation of the BIOS Trifocal IOL and were assessed at 30 and 90 days post-surgery. The evaluations included measurements of patient-reported outcomes using the NEI-VFQ 25 at postoperative day 30 and uncorrected and corrected distance visual acuity and defocus curves at postoperative day 90. Additionally, intraoperative and postoperative complications were documented. Visual acuity assessments were performed under photopic conditions, with a range of defocus from + 1.5 D to -3.0 D.

resultsSignificant improvements were observed in uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), and near visual acuity (UNVA) at both 30 and 90 days post-surgery (p < 0.001). The defocus curve demonstrated functional vision from + 1.5 D to -3.0 D, supporting the lens's efficacy for near, intermediate, and far distances. Quality of life, as assessed by the NEI-VFQ 25, showed marked improvement across all domains (p < 0.05), with no significant complications directly attributable to the IOL.

conclusionsThe BIOS Trifocal IOL presented satisfactory effectivity in the treatment of cataract and presbyopia, providing functional vision across near, intermediate and far distances and maintaining good patient satisfaction.

trial registrationThis trial was registered at the ReBEC (Registro Brasileiro de Ensaios Clínicos - Brazilian Registry of Clinical Trials)database under the registration code RBR-772s6y at April 6th, 2020.

Indexed as

Lens Implantation, IntraocularMultifocal Intraocular LensesPhacoemulsificationPresbyopiaPseudophakiaQuality of LifeVisual AcuityAgedAged, 80 and overContrast SensitivityFemaleHumansMaleMiddle AgedPatient SatisfactionProspective StudiesCataractIntraocular lensesMultifocal IOLsPresbyopia correcting IOLsTrifocal IOLs

Identifiers

PMID39901127
PMCPMC11792698

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.