Evidence map›Paper›PMID 21386913›Full record

ArticleClinical ophthalmology (Auckland, N.Z.)2011

Efficacy and tolerability of a combined gatifloxacin plus prednisolone formulation for topical prophylaxis after LASIK.

Mauro Campos, Cristina Muccioli, João Bns Malta, Rafael A Gerade, André LA Salame, Rubens Belfort

Open access · goldAbstract read
In one paragraph

Article in Clinical ophthalmology (Auckland, N.Z.), 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 22% 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, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. 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 1 institution in 1 country.

Mauro CamposDepartment of Ophthalmology, Hospital São Paulo, Universidade Federal de São Paulo, Brazil.
Cristina Muccioli
João Bns Malta
Rafael A Gerade
André LA Salame
Rubens Belfort
Hospital São Paulo · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo compare the efficacy and tolerability of a fixed-dose combination of 0.3% gatifloxacin and 1% prednisolone formulation versus the same agents administered separately for prophylaxis in a laser-assisted in situ keratomileusis (LASIK) population.

methodsIn a prospective, randomized, double-masked, parallel-group study, 97 patients were evaluated for signs and symptoms of ocular infection or inflammation after bilateral LASIK. Group 1 (50 patients, 100 eyes) received a combined formulation of 0.3% gatifloxacin + 1% prednisolone acetate (Zypred(®)) plus placebo. Group 2 (47 patients, 94 eyes) received conventional treatment with the same agents from separate vials. The cohorts were similar in age, sex, race, and refractive error. Baseline and postoperative assessments were made on surgery days -2, 1, 3, and 15 and consisted of visual acuity; intraocular pressure; severity of inflammation of eyelids, conjunctiva, and cornea; tearing; ocular discomfort (foreign-body sensation, itching, or photophobia); and ocular pain. The posterior segment was evaluated at the screening and exit visits.

resultsNo ocular infection or persistent inflammation was detected in either group at any time. All objective and subjective criteria of efficacy were similar regardless of treatment, with no significant differences between the groups. More patients who were dosed with the combined agent complained of mild ocular discomfort on day 3, but this difference had disappeared by day 15.

conclusionPost-LASIK topical prophylaxis with combined gatifloxacin + prednisolone eye drops (Zypred(®)) was well tolerated. This formulation appears to be therapeutically equivalent to conventional dosing with gatifloxacin and prednisolone from individual bottles for topical prophylaxis after laser refractive surgery.

Indexed as

gatifloxacinLASIKprednisoloneprophylaxis

Identifiers

PMID21386913
PMCPMC3046990
OpenAlexW2029883937

What OpenQuestion holds

Textmetadata
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.