Evidence map›Paper›PMID 31571089›Full record

Trial reportInternational ophthalmology2020

Efficacy of topical microemulsion of fatty acids of the ω-3 series on the sub-epithelial corneal nerves regeneration after epithelium-off corneal collagen cross-linking for keratoconus.

Carlo Cagini, Marco Messina, Giovanni Torroni, Francesca Riccitelli, Marco Mariniello, Harminder S Dua

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in International ophthalmology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 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

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Article
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.

Carlo CaginiDepartment of Surgical and Biomedical Sciences, Division of Ophthalmology, Ospedale S. Maria della Misericordia, S. Andrea Delle Fratte, University of Perugia, 06156, Perugia, Italy. carlo.cagini@unipg.it.ORCID http://orcid.org/0000-0002-3812-9219
Marco MessinaDepartment of Surgical and Biomedical Sciences, Division of Ophthalmology, Ospedale S. Maria della Misericordia, S. Andrea Delle Fratte, University of Perugia, 06156, Perugia, Italy.
Giovanni TorroniDepartment of Surgical and Biomedical Sciences, Division of Ophthalmology, Ospedale S. Maria della Misericordia, S. Andrea Delle Fratte, University of Perugia, 06156, Perugia, Italy.
Francesca RiccitelliDepartment of Surgical and Biomedical Sciences, Division of Ophthalmology, Ospedale S. Maria della Misericordia, S. Andrea Delle Fratte, University of Perugia, 06156, Perugia, Italy.
Marco MarinielloDepartment of Surgical and Biomedical Sciences, Division of Ophthalmology, Ospedale S. Maria della Misericordia, S. Andrea Delle Fratte, University of Perugia, 06156, Perugia, Italy.
Harminder S DuaSection of Academic Ophthalmology, Division of Clinical Neuroscience, Nottingham University Hospitals NHS Trust, University of Nottingham, Nottingham, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo evaluate efficacy of a microemulsion of fatty acids of the ω-3 series on the regeneration of the sub-epithelial corneal nerve plexus in patients with keratoconus after epi-off cross-linking.

methodsIn this prospective study, we recruited 40 patients, 18 females, mean age 28 years (range 22-37), who were randomly divided in two groups. Group A, 20 patients, after cross-linking were treated with a microemulsion of fatty acids of the ω-3 series. Group B were treated with hyaluronic acid (0.15%)-based tear substitute. Nerve tortuosity, reflectivity and density were examined with in vivo confocal microscopy. Ocular surface disease index (OSDI) questionnaire at the preoperative and at each follow-up visit (1, 3 and 6 months) after treatment was completed.

resultsNo significant difference between the two groups was noted at 1 month in terms of nerve density and OSDI. A statistically significant difference between the two groups was detected at 3 months in terms of nerve fibers density (6 ± 0.82 in Group A and 1 ± 0.51 in Group B, P = 0.0001). Reflectivity and tortuosity of the fibers did not show significant differences between the two groups at any time point. At 1 month, OSDI average value in group A and in group B was 31.5 ± 1.94 and 30 ± 1.96, at 3 months 13 ± 1.71 and 28 ± 1.83, and at 6 months 10.5 ± 1.87 and 9.0 ± 1.81, respectively.

conclusionThe use of a microemulsion of fatty acids appears to ensure a faster regeneration of nerve fibers in patients undergoing epi-off cross-linking.

Indexed as

Administration, TopicalAdultCollagenCross-Linking ReagentsEmulsionsEpithelium, CornealFatty AcidsFemaleFollow-Up StudiesHumansKeratoconusMaleMicroscopy, ConfocalNerve FibersNerve RegenerationPhotochemotherapyCollagenCross-Linking ReagentsEmulsionsFatty AcidsPhotosensitizing AgentsRiboflavinCross-linkingEye drops; Omega-3 essential fatty acidsRegenerationSub-epithelial corneal nerves

Identifiers

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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.