Evidence map›Paper›PMID 34234407›Full record

Trial reportClinical ophthalmology (Auckland, N.Z.)2021

Short-Term Use of Dexamethasone/Netilmicin Fixed Combination in Controlling Ocular Inflammation After Uncomplicated Cataract Surgery.

Aldo Caporossi, Giovanni Alessio, Francesco Fasce, Giorgio Marchini, Antonio Rapisarda, Vincenzo Papa

Open access · goldAbstract readCase ReportsClinical Trial
In one paragraph

Trial report in Clinical ophthalmology (Auckland, N.Z.), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact, top 89% 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

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. 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 at 5 institutions in 1 country.

Aldo CaporossiDepartment of Ophthalmology, Policlinico Universitario A. Gemelli IRCSS Università Cattolica del Sacro Cuore, Roma, Italy.
Giovanni AlessioOphthalmology Unit, Dipartimento di Scienze mediche di base, Neuroscienze e Organi di Senso Università di Bari, Azienda Ospedaliera Policlinico Consorziale, Bari, Italy.ORCID 0000-0001-8313-4159
Francesco FasceOphthalmology Unit, IRCSS San Raffaele, Milano, Italy.
Giorgio MarchiniOphthalmology Unit, Ospedale Policlinico G.B. Rossi, Università di Verona, Verona, Italy.ORCID 0000-0002-4657-3168
Antonio RapisardaOphthalmology Unit, Azienda Ospedaliera Garibaldi, Catania, Italy.ORCID 0000-0002-2594-365X
Vincenzo PapaMedical Affairs SIFI SpA, Catania, Italy.ORCID 0000-0001-7697-6059
Azienda Universitaria Ospedaliera Consorziale - Policlinico Bari · ITIRCCS Ospedale San Raffaele · ITOspedale Garibaldi · ITUniversità Cattolica del Sacro Cuore · ITUniversity of Verona · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo evaluate the short-term anti-inflammatory effect of dexamethasone/netilmicin fixed combination in the management of ocular inflammation after cataract surgery. PATIENTS AND

methodsOpen-label, randomized, active-controlled, clinical study conducted in 6 sites in Italy; 238 patients were randomized 2:1 to dexamethasone/netilmicin (dexa/net, n=158) or betamethasone/chloramphenicol (beta/chl, n=80). Treatment started the day of surgery and continued 4 times daily for 7 days. The primary efficacy parameter was the anterior chamber (AC) flare. The percentage of patients displaying none or mild (ie, only barely detectable) AC flare was defined as "efficacy rate", whereas the percentage of patients showing a decrease of AC flare score from baseline was defined as "percentage of responders". Additional parameters evaluated were AC cells, conjunctival hyperaemia, corneal and lid oedema, symptoms of ocular discomfort, visual acuity, and intraocular pressure. Dexa/net was considered effective if the efficacy rate was not inferior (by means of 97.5% confidence interval) to that of beta/chl.

resultsAfter 7 days of treatment, no AC flare was observed in 92.8% (dexa/net) and 92.3% (beta/chl) of patients, whereas no AC cells were observed in 91.5% (dexa/net) and 93.6% (beta/chl) of patients, respectively. The "efficacy rate" was 100% in both groups, whereas the "percentage of responders" was 94.1% in the dexa/net and 93.6% in the beta/chl group. The p-value to reject the null hypothesis of inferiority was <0.001. Other efficacy parameters confirmed both treatments as highly effective, despite their difference in steroid content (2 mg/mL for beta/chl vs 1 mg/mL for dexa/net). IOP and visual acuity at the end of the study were comparable. Two cases of allergic conjunctivitis were considered adverse events and were both related to dexa/net.

conclusionShort-term use of dexa/net fixed combination is safe and effective in the control of post-operative inflammation following uncomplicated cataract surgery.

Indexed as

cataract surgerychloramphenicolfixed combinationnetilmicin

Identifiers

PMID34234407
PMCPMC8256380
OpenAlexW3176117153

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.