Evidence map›Paper›PMID 42376480›Full record

ArticleClinical ophthalmology (Auckland, N.Z.)2026

Two-Year Follow-Up of the MINI WELL Non-Diffractive Extended Depth-of-Focus Intraocular Lens: A Retrospective Observational Study.

Alessandra Sborgia, Maria Cristina Curatolo, Dionisio Franco Barattini, Alfredo Niro, Luca Barattini, Giancarlo Sborgia

Registry-linked trialAbstract read
In one paragraph

Article in Clinical ophthalmology (Auckland, N.Z.), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04801992 (Retrospective, Observational, Monocenter And Single-Arm Trial Following Subjects Bilaterally Implanted With Mini Well Ready For 2 Years After The Second Eye Implant), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

NCT04801992 completednot on this map

Retrospective, Observational, Monocenter And Single-Arm Trial Following Subjects Bilaterally Implanted With Mini Well Ready For 2 Years After The Second Eye Implant

TypeobservationalSponsorSIFI SpARan2020 to 2020Enrolled23ConditionsCataractArmsMINI WELL Ready (SIFI SpA, Italy)
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Alessandra SborgiaEye Clinic Dept, Hospital "SS. Annunziata" ASL Taranto, Taranto, Italy.ORCID 0000-0001-9081-0434
Maria Cristina CuratoloInnovation and Medical Science Department, SIFI Spa, Aci Sant'Antonio, Catania, Italy.ORCID 0009-0001-8739-8079
Dionisio Franco BarattiniMedical Department, Opera CRO, a Tigermed Company, Timisoara, Romania.ORCID 0000-0001-9931-6432
Alfredo NiroEye Clinic Dept, Hospital "SS. Annunziata" ASL Taranto, Taranto, Italy.ORCID 0000-0002-7951-3591
Luca BarattiniIT Department, TIGERMED Italy, Genova, Italy.ORCID 0009-0003-5568-5916
Giancarlo SborgiaDepartment of Medical Science, NeuroScience and Sense Organs, University of Bari, Bari, Italy.ORCID 0000-0001-7271-0536

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: To describe long-term visual outcomes, functional vision, and safety following implantation of the MINI WELL non-diffractive extended depth-of-focus (EDoF) intraocular lens over a two-year follow-up period. Materials and methods: This monocentric, retrospective, observational study included patients who underwent cataract surgery with binocular implantation of the MINI WELL non-diffractive EDoF intraocular lens. Visual outcomes were assessed postoperatively over 24 months. Evaluations included monocular and binocular uncorrected and corrected visual acuity at distance, intermediate, and near; defocus curve assessment under photopic conditions; contrast sensitivity; binocular reading performance using Radner Reading Charts; and patient-reported outcomes measured with the Visual Function Questionnaire VF-11R. Safety outcomes included adverse events, secondary surgical interventions, and patient-reported photic phenomena. Results: Twenty-three patients (46 eyes) completed the two-year follow-up and were included in the analysis. At 24 months, monocular and binocular visual acuity was maintained across all tested distances. Binocular uncorrected distance visual acuity of 20/32 Snellen or better was achieved in all patients. Intermediate and near visual acuity were consistent with common daily visual tasks. The binocular defocus curve demonstrated a smooth decline in visual acuity across intermediate defocus levels without distinct focal gaps. Mean binocular reading speed at near distance met established criteria for fluent reading. Contrast sensitivity remained within manufacturer-defined normative ranges across spatial frequencies. Patient-reported outcomes indicated minimal difficulty in vision-dependent daily activities. No intraoperative or postoperative adverse events, secondary surgical interventions, or clinically relevant late complications were reported. Mild photic phenomena were infrequently reported. Conclusion: At two years, implantation of the MINI WELL non-diffractive EDoF intraocular lens was associated with maintained visual outcomes, functional intermediate and near vision, and a favorable safety profile. These findings support the long-term stability of visual performance with this EDoF intraocular lens. Larger prospective and comparative studies are warranted to confirm these observations. Trial Registration: ClinicalTrials.gov identifier NCT04801992.

Indexed as

cataractdefocus curveextended depth-of-focusintraocular lenspresbyopiasafetyvisual performance

Identifiers

PMID42376480
PMCPMC13311217

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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.