Evidence map›Paper›PMID 38580741›Full record

Trial reportEye (London, England)2024

Quality of vision clinical outcomes for a new fully-refractive extended depth of focus Intraocular Lens.

Dean Corbett, Daniel Black, Timothy V Roberts, Brendan Cronin, David Gunn, Chandra Bala, Patrick Versace, Linda Tsai, Eleni Papadatou, Aixa Alarcon and 1 more

Erratum issuedAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Eye (London, England), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 30 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 2 pooled it
–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

30 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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  5. Clinical outcomes of a new presbyopia-correcting intraocular lens with spiral optic.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2026
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors.

Dean CorbettAuckland Eye, Auckland, New Zealand.
Daniel BlackSunshine Eye Clinic, Birtinya, QLD, Australia.
Timothy V RobertsVision Eye Institute, Sydney, NSW, Australia.
Brendan CroninQueensland Eye Institute Foundation, South Brisbane, QLD, Australia.ORCID 0000-0002-4443-8915
David GunnQueensland Eye Institute Foundation, South Brisbane, QLD, Australia.ORCID 0000-0001-8056-927X
Chandra BalapersonalEYES, Parramatta, NSW, Australia.
Patrick VersaceDr Versace, SMS healthcare, University of New South Wales, Sydney, NSW, Australia.
Linda TsaiJohnson and Johnson MedTech, Irvine, CA, USA.
Eleni PapadatouJohnson and Johnson MedTech, Irvine, CA, USA.
Aixa AlarconJohnson and Johnson MedTech, Groningen, The Netherlands.ORCID 0000-0002-6288-0141
Srividhya VilupuruJohnson and Johnson MedTech, Irvine, CA, USA. SVilupur@ITS.JNJ.com.ORCID 0009-0006-2011-0807

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND/

objectiveTo evaluate the visual performance of a purely refractive extended depth of focus (EDF) intraocular lens (IOL). SUBJECTS/

methodsA prospective, multi-center, randomized, subject/evaluator-masked study. Subjects were bilaterally implanted with the EDF test (Model ZEN00V, TECNIS PureSee™ IOL, N = 60) or an enhanced monofocal control (Model ICB00, TECNIS Eyhance™ IOL, N = 57) IOL. Monocular corrected distance (CDVA), intermediate (DCIVA), near acuities (DCNVA) and patient reported visual symptoms were evaluated at the 6-month visit. Monocular mesopic contrast sensitivity (CS) and depth of focus (DOF) testing were assessed at 3 months.

resultsCDVA (Mean ± SD) was -0.06 ± 0.08 for test and -0.05 ± 0.08 logMAR for control groups. DCIVA was 0.13 ± 0.08 for test and 0.18 ± 0.14 logMAR for control groups (p = 0.0127). DCNVA was 0.37 ± 0.10 for test and 0.43 ± 0.16 logMAR for control groups (p = 0.0137). Test lens was statistically superior for intermediate and near. Overall, 91.7% (halos), 95.0% (starbursts) and 95.0% (glare) of test lens patients reported that they did not experience, were not bothered, or were slightly bothered by specific visual symptoms, compared to 98.2%, 100% and 96.5% in the control group. The DOF range over which monocular visual acuity was 0.20 logMAR or better was -1.6 D for the test lens. Mesopic CS was comparable between both groups, falling within 0.11 log units for all measured cycles per degree with and without glare.

conclusionThe EDF IOL demonstrated extended range of vision and statistically superior intermediate and near performance compared to the monofocal IOL. Distance visual acuity, contrast sensitivity and dysphotopsia profile were similar to the monofocal IOL.

Indexed as

Contrast SensitivityDepth PerceptionLenses, IntraocularLens Implantation, IntraocularPseudophakiaVisual AcuityAgedDouble-Blind MethodFemaleHumansMaleMiddle AgedPatient SatisfactionPhacoemulsificationProspective StudiesProsthesis Design

Identifiers

PMID38580741
PMCPMC11080637

What OpenQuestion holds

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Registered trials

None linked

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.