Evidence map›Paper›PMID 34772665›Full record

Trial reportThe British journal of ophthalmology2023

Safety and performance of a suprachoroidal sensor for telemetric measurement of intraocular pressure in the EYEMATE-SC trial.

Peter Szurman, Kaweh Mansouri, H Burkhard Dick, Andre Mermoud, Esther M Hoffmann, Marc Mackert, Robert N Weinreb, Harsha Laxmana Rao, Anna-Maria Seuthe, EYEMATE-SC study group

Registry-linked trialOpen access · bronzeAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in The British journal of ophthalmology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03756662 (A Prospective, Open-label, Single Arm, Multicenter Clinical Investigation to Assess the Safety and Performance of the ARGOS-SC Suprachoroidal Pressure Sensor System in Patients With Glaucoma Undergoing Non-penetrating Glaucoma Surgery), which is not on this map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
2.2field-weighted citation impact, top 12% 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.

NCT03756662 nacompletednot on this map

A Prospective, Open-label, Single Arm, Multicenter Clinical Investigation to Assess the Safety and Performance of the ARGOS-SC Suprachoroidal Pressure Sensor System in Patients With Glaucoma Undergoing Non-penetrating Glaucoma Surgery

TypeinterventionalSponsorImplandata Ophthalmic Products GmbHRan2018 to 2021Enrolled24ConditionsGlaucoma, Open Angle GlaucomaArmsARGOS-SC suprachoroidal pressure sensor
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 21 citations in OpenAlex.

  1. Home monitoring devices for glaucoma.Indian journal of ophthalmology · 2026
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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

10 authors at 5 institutions in 3 countries.

Peter SzurmanEye Clinic Sulzbach, Knappschaft Hospital Saar, 66280 Sulzbach, Germany Peter.Szurman@kksaar.de.
Kaweh MansouriGlaucoma Research Centre, Montchoisi Hospital, Lausanne, Switzerland.
H Burkhard DickEye Clinic, University Hospital of the Ruhr University Bochum, Bochum, Germany.
Andre MermoudGlaucoma Research Centre, Montchoisi Hospital, Lausanne, Switzerland.
Esther M HoffmannOphthalmology, University Medical Centre of the Johannes Gutenberg University Mainz, Mainz, Germany.
Marc MackertDepartment of Ophthalmology, University Hospital, Ludwig-Maximilians-Universitat Munchen Medizinische Fakultat, Munich, Germany.
Robert N WeinrebDepartment of Ophthalmology at the Shiley Eye Institute, University of California at San Diego, La Jolla, California, USA.
Harsha Laxmana RaoGlaucoma, Narayana Nethralaya, Bangalore, India.ORCID 0000-0001-5866-9856
Anna-Maria SeutheEye Clinic Sulzbach, Saar Knappschaft Hospital Sulzbach, Sulzbach, Germany.ORCID 0000-0002-3195-6537
EYEMATE-SC study group
Knappschaftsklinikum Saar · DEJohannes Gutenberg University Mainz · DELudwig-Maximilians-Universität München · DEMaastricht University Medical Centre · NLUniversity Hospitals of the Ruhr-University of Bochum · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo investigate the safety and performance of a telemetric suprachoroidal intraocular pressure (IOP) sensor (EYEMATE-SC) and the accuracy of its IOP measurements in open angle glaucoma (OAG) patients undergoing simultaneous non-penetrating glaucoma surgery (NPGS).

methodsProspective, multicentre, open-label, single-arm, interventional clinical trial. Twenty-four eyes of 24 patients with OAG regularly scheduled for NPGS (canaloplasty or deep sclerectomy) were simultaneously implanted with an EYEMATE-SC sensor. Six-month follow-up on the sensor's safety and performance as well as on the level of agreement between the EYEMATE-SC measurements and IOP measurements with Goldmann applanation tonometry (GAT).

resultsThe eyes underwent canaloplasty (n=15) or deep sclerectomy (n=9) and achieved successful implantation of the sensor. No device migration, dislocation or serious device-related complications occurred. A total of 367 comparisons were included in the IOP agreement analysis. The overall mean difference between GAT and EYEMATE-SC measurements was 1.31 mm Hg (lower limit of agreement (LoA) 7.55 mm Hg; upper LoA -4.92 mm Hg). The maximum difference of 2.5 mm Hg ±3.96 (LoA 0.30-2.29) was reached on day 10 and continuously improved to an agreement of -0.15 mm Hg ±2.28 (LoA -1.24 to 0.89) after 6 months. Accordingly, the percentage of eyes within an IOP difference of ±5 mm Hg improved from 78% (day 3) to 100% (6 months).

conclusionsAfter 6 months, the EYEMATE-SC sensor was safe and well tolerated, and allowed continual IOP monitoring. TRIAL REGISTRATION NUMBER: NCT03756662.

Indexed as

Glaucoma, Open-AngleIntraocular PressureGalactosylceramidesHumansProspective StudiesTonometry, OcularGalactosylceramidesN-palmitoylgalactosylsphingosineglaucomaintraocular pressuretreatment surgery

Identifiers

PMID34772665
PMCPMC10086291
OpenAlexW3212306989

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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Registered trials

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.