Evidence map›Paper›PMID 30758653›Full record

Trial reportGraefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie2019

Two-year results of a multicenter study of the ab interno gelatin implant in medically uncontrolled primary open-angle glaucoma.

Herbert Reitsamer, Chelvin Sng, Vanessa Vera, Markus Lenzhofer, Keith Barton, Ingeborg Stalmans, Apex Study Group

Registry-linked trialOpen access · hybridAbstract readClinical TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02006693 (Post Market Multicentric Evaluation of the AqueSys XEN Implant in Moderate Primary Open Angle Glaucoma Subjects), which is not on this map. Cited by 109 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
109citing papers in PubMed, 6 pooled it
27.9field-weighted citation impact, top 1% 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.

NCT02006693 phase4completednot on this map

Post Market Multicentric Evaluation of the AqueSys XEN Implant in Moderate Primary Open Angle Glaucoma Subjects

TypeinterventionalSponsorAqueSys, Inc.Ran2013 to 2017Enrolled199ConditionsPrimary Open Angle GlaucomaArmsXEN® Gel Stent, Cataract Surgery
3 · Its place in the literature

Who cites it

109 citing papers in PubMed, 6 syntheses or guidelines pooled it, 212 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Standalone XEN45 Gel Stent implantation versus combined XEN45-phacoemulsification in the treatment of open angle glaucoma-a systematic review and meta-analysis.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2021
    Pooled it
  7. Trial
  8. Trial
  9. Predicting bleb revision after XEN gel stent surgery in a real-world open-angle glaucoma cohort.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2026
    Article
  10. The efficacy and safety of the XEN63 glaucoma gel stent without Mitomycin C over the first 10 years.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2026
    Article
  11. Article
  12. Management and outcomes of primary open-angle glaucoma.Journal of family medicine and primary care · 2026
    Review
  13. Article
  14. Outcomes of Ab Interno 63 µm vs. 45 µm XENJournal of clinical medicine · 2026
    Article
  15. Review
  16. Article
  17. Longitudinal analysis of XEN45 gel stent bleb morphology using bleb grading scales, anterior segment-OCT, in vivo confocal microscopy, and impression cytology.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2026
    Article
  18. Review
  19. Reducing Postoperative Needling in XEN63Journal of clinical medicine · 2025
    Article
  20. Article

49 more citing papers are in PubMed but not listed here.

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

7 authors at 3 institutions in 4 countries.

Herbert ReitsamerDepartment of Ophthalmology and Optometry, University Clinic Salzburg, SALK/Paracelsus Medical University, Salzburg, Austria.
Chelvin SngMoorfields Eye Hospital, London, UK. chelvin@gmail.com.
Vanessa VeraDepartment of Ophthalmology, Unidad Oftalmologica de Caracas, Caracas, Venezuela.
Markus LenzhoferDepartment of Ophthalmology and Optometry, University Clinic Salzburg, SALK/Paracelsus Medical University, Salzburg, Austria.
Keith BartonMoorfields Eye Hospital, London, UK.
Ingeborg StalmansDepartment of Ophthalmology, University Hospitals UZ Leuven, Leuven, Belgium.
Apex Study Group
Paracelsus Medical University · ATUniversitair Ziekenhuis Leuven · BESingapore Eye Research Institute · SG

Funding

Allergan plc N/A
6 · The paper itself

Abstract

purposeTo evaluate the effectiveness of an ab interno subconjunctival gelatin implant as primary surgical intervention in reducing intraocular pressure (IOP) and IOP-lowering medication count in medically uncontrolled moderate primary open-angle glaucoma (POAG).

methodsIn this prospective, non-randomized, open-label, multicenter, 2-year study, eyes with medicated baseline IOP 18-33 mmHg on 1-4 topical medications were implanted with (phaco + implant) or without (implant alone) phacoemulsification. Changes in mean IOP and medication count at months 12 (primary outcomes) and 24, clinical success rate (eyes [%] achieving ≥ 20% IOP reduction from baseline on the same or fewer medications without glaucoma-related secondary surgical intervention), intraoperative complications, and postoperative adverse events were assessed.

resultsThe modified intent-to-treat population included 202 eyes (of 218 implanted). Changes (standard deviation) in mean IOP and medication count from baseline were - 6.5 (5.3) mmHg and - 1.7 (1.3) at month 12 and - 6.2 (4.9) mmHg and - 1.5 (1.4) at month 24, respectively (all P < 0.001). Mean medicated baseline IOP was reduced from 21.4 (3.6) to 14.9 (4.5) mmHg at 12 months and 15.2 (4.2) mmHg at 24 months, with similar results in both treatment groups. The clinical success rate was 67.6% at 12 months and 65.8% at 24 months. Overall, 51.1 (12 months) and 44.7% (24 months) of eyes were medication-free. The implant safety profile compared favorably with that published for trabeculectomy and tube shunts.

conclusionsThe gelatin implant effectively reduced IOP and medication needs over 2 years in POAG uncontrolled medically, with an acceptable safety profile. ClinicalTrials.gov registration number: NCT02006693 (registered in the USA).

Indexed as

Glaucoma Drainage ImplantsAgedAntihypertensive AgentsFemaleFollow-Up StudiesGelatinGlaucoma, Open-AngleHumansIntraocular PressureMaleProspective StudiesProsthesis DesignTime FactorsAntihypertensive AgentsGelatinAb internoGlaucomaImplantMinimally invasive glaucoma surgeryStentXEN

Identifiers

PMID30758653
OpenAlexW2912968083

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.