Evidence map›Paper›PMID 37221362›Full record

Trial reportEye (London, England)2023

Changing from preserved, to preservative-free cyclosporine 0.1% enhanced triple glaucoma therapy: impact on ocular surface disease-a randomized controlled trial.

Anastasios-Georgios Konstas, Konstadinos G Boboridis, Georgios P Athanasopoulos, Anna-Bettina Haidich, Irini C Voudouragkaki, Eirini Pagkalidou, Andreas Katsanos, L Jay Katz

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Eye (London, England), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
2.6field-weighted citation impact, top 11% 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

4 citing papers in PubMed, 9 citations in OpenAlex.

  1. Observational
  2. Review
  3. Review
  4. 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

8 authors at 3 institutions in 2 countries.

Anastasios-Georgios Konstas1st University Department of Ophthalmology, Aristotle University of Thessaloniki, Thessaloniki, Greece. agkonstas@gmail.com.
Konstadinos G Boboridis1st University Department of Ophthalmology, Aristotle University of Thessaloniki, Thessaloniki, Greece.ORCID 0000-0002-0471-0371
Georgios P Athanasopoulos1st University Department of Ophthalmology, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Anna-Bettina HaidichDepartment of Epidemiology, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Irini C Voudouragkaki1st University Department of Ophthalmology, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Eirini PagkalidouDepartment of Epidemiology, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Andreas KatsanosDepartment of Ophthalmology, University of Ioannina, Ioannina, Greece.ORCID 0000-0001-6623-8503
L Jay KatzGlaucoma Research Center, Wills Eye Hospital, Philadelphia, PA, USA.
Aristotle University of Thessaloniki · GRUniversity of Ioannina · GRWills Eye Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveHalting and reversing glaucoma therapy-related ocular surface disease (GTR-OSD) will improve the success of long-term medical therapy, impacting millions of patients worldwide.

methodsA single-centre, masked, prospective, placebo-controlled, crossover trial of 41 well-controlled open-angle glaucoma subjects with moderate to severe GTR-OSD on preserved latanoprost and dorzolamide/timolol fixed combination (DTFC) therapy was conducted. Subjects were randomized to preservative-free (PF) tafluprost and DTFC with either placebo or cyclosporine 0.1% drops for 6 months and were then crossed over to the opposite therapy. Oxford score of ocular staining was the primary outcome; osmolarity, matrix-metalloproteinase-9 (MMP-9) testing, tear film break-up time (TFBUT), meibomian gland dysfunction (MGD), punctum evaluation, adverse events and diurnal intraocular pressure (IOP) comprised secondary outcomes.

resultsGTR-OSD findings improved with PF therapy. At 6 months the triple PF with placebo group showed improvement compared to baseline in mean Oxford score (mean difference [MD]:-3.76; 95% confidence interval [CI]:-4.74 to -2.77; p < 0.001), osmolarity (MD:-21.93; 95%CI:-27.61 to -16.24 mOsm/l; p < 0.001), punctum stenosis (p = 0.008) and conjunctival hyperaemia (p < 0.001). Similar improvements occurred in the cyclosporine enhanced period, which also provided greater improvement in MMP-9 positivity (24 vs 66%; p < 0.001) and TFBUT (p = 0.022). The cyclosporine group was superior vs placebo in mean Oxford score (MD:-0.78; 95%CI:-1.40 to -0.15); p < 0.001), itchiness and objective adverse events (p = 0.034). Cyclosporine elicited more stinging vs placebo (63 vs 24%; p < 0.001). Both PF regimens reduced mean diurnal IOP more than preserved therapy (14.7 vs 15.9 mmHg; p < 0.001).

conclusionsChanging from preserved to PF glaucoma medications improves ocular surface health and IOP control. Topical cyclosporine 0.1% further reverses GTR-OSD.

Indexed as

CyclosporinsGlaucomaGlaucoma, Open-AngleOcular HypertensionAntihypertensive AgentsDrug CombinationsHumansIntraocular PressureMatrix Metalloproteinase 9Preservatives, PharmaceuticalProspective StudiesTimololTreatment OutcomeAntihypertensive AgentsCyclosporinsDrug CombinationsMatrix Metalloproteinase 9Preservatives, PharmaceuticalTimolol

Identifiers

PMID37221362
PMCPMC10686389
OpenAlexW4377826036

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.