Evidence map›Paper›PMID 33116381›Full record

Trial reportClinical ophthalmology (Auckland, N.Z.)2020

Dexamethasone/Netilmicin Eye Drops and Eye Gel for the Treatment of Ocular Inflammation After Micro-Incisional Vitreoretinal Surgery.

Antonio Rapisarda, Paolo Arpa, Paolo Maria Fantaguzzi, Francesco Faraldi, Roberto Ratiglia, Stanislao Rizzo, Paola Vaona, Claudio Iannacone, Vincenzo Papa

Open access · goldAbstract readCase ReportsClinical Trial
In one paragraph

Trial report in Clinical ophthalmology (Auckland, N.Z.), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.5field-weighted citation impact, top 35% of its field
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

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. Trial
  3. 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

9 authors at 8 institutions in 1 country.

Antonio RapisardaDepartment of Ophthalmology, Azienda Ospedaliera Garibaldi, Catania, Italy.ORCID 0000-0002-2594-365X
Paolo ArpaDepartment of Ophthalmology, Ospedale San Gerardo, Monza, Italy.
Paolo Maria FantaguzziDepartment of Ophthalmology, Ospedale Morgagni Pierantoni, Forlì, Italy.
Francesco FaraldiDepartment of Ophthalmology, Presidio Ospedaliero Oftalmico, Torino, Italy.
Roberto RatigliaDepartment of Ophthalmology, Policlinico Mangiagalli Regina Elena, Milano, Italy.
Stanislao RizzoDepartment of Ophthalmology, Azienda Ospedaliera Pisana, Pisa, Italy.
Paola VaonaDepartment of Ophthalmology, Presidio Ospedaliero Oftalmico, Torino, Italy.ORCID 0000-0002-3667-6040
Claudio IannaconeSparc Consulting, Milano, Italy.
Vincenzo PapaMedical Affairs, SIFI SpA, Catania, Italy.
Presidio Ospedaliero · ITAzienda Ospedaliera San Gerardo · ITAzienda Ospedaliera Universitaria Pisana · ITFIT Consulting (Italy) · ITOspedale Garibaldi · ITOspedale G.B. Morgagni - L.Pierantoni · ITOspedale Maggiore · ITSIFI Medtech (Italy) · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo evaluate the effect of dexamethasone/netilmicin (dexa/net) fixed combination in the treatment of ocular inflammation after sutureless micro-incisional vitreoretinal surgery (MIVS). PATIENTS AND

methodsThis multicenter, open, randomized, active-controlled, parallel-group, clinical trial was run in 6 sites in Italy. Treatment started the day of surgery and continued 4 times daily for 14 days. Patients were 1:1 randomized to dexa/net (eyedrops solution and eye gel) or dexamethasone/tobramycin (dexa/tobra) eyedrops suspension and ointment. Viscous formulations (gel or ointment) were used alone during the early post-operative phase; afterwards, a combination of eye drops during daytime and viscous formulations at bedtime was adopted. The primary efficacy parameter evaluated was bulbar conjunctival hyperemia. Additional efficacy and safety parameters (palpebral conjunctival hyperemia, anterior chamber flare and cells, symptoms of ocular discomfort and ocular tolerance, adverse events and intraocular pressure) were also evaluated. Control visits were performed at day 1, day 4 and day 14 after surgery; the endpoint of the study was set at 14±2 days after surgery.

resultsA complete resolution of bulbar conjunctiva hyperaemia at the study end point was reached in 92.9% of patients treated with dexa/net and 75.0% of those treated with dexa/tobra (p=0.02, Fisher's exact test). No differences were observed between treatments for other efficacy parameters. Statistically significant differences in favour of dexa/net (p< 0.0001, ANOVA) were observed for most of subjective tolerance variables examined (blurred vision, foreign body sensation, stickiness, burning) starting day 1 after surgery when only the viscous formulations were used. No increase in intraocular pressure or adverse events was observed during the study.

conclusionThe combination dexa/net is safe and effective in the treatment of post-operative inflammation following sutureless MIVS. In particular, the use of eye gel formulation is characterized by a great tolerability.

Indexed as

fixed combinationtolerabilityvitreoretinal surgeryxanthan gum

Identifiers

PMID33116381
PMCPMC7569042
OpenAlexW3093174233

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.