Evidence map›Paper›PMID 27619225›Full record

ArticleOphthalmology and therapy2016

Newly Diagnosed Primary Open-Angle Glaucoma Randomized to 2 Trabecular Bypass Stents or Prostaglandin: Outcomes Through 36 Months.

Steven D Vold, Lilit Voskanyan, Manfred Tetz, Gerd Auffarth, Imran Masood, Leon Au, Iqbal Ike K Ahmed, Hady Saheb

Erratum issued Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Ophthalmology and therapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT01443988 (A Prospective, Randomized Evaluation of Subjects With Open-angle Glaucoma, Pseudoexfoliative Glaucoma, or Ocular Hypertension Naïve to Medical and Surgical Therapy, Treated With Two Trabecular Micro-bypass Stents), which is not on this map. Cited by 32 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 5 pooled it
7.9field-weighted citation impact, top 2% 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.

NCT01443988 phase4completednot on this map

A Prospective, Randomized Evaluation of Subjects With Open-angle Glaucoma, Pseudoexfoliative Glaucoma, or Ocular Hypertension Naïve to Medical and Surgical Therapy, Treated With Two Trabecular Micro-bypass Stents (iStent) or Travoprost Ophthalmic Solution 0.004%

TypeinterventionalSponsorGlaukos CorporationRan2011 to 2017Enrolled101ConditionsOpen-angle GlaucomaArmsiStent, Travoprost
3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 5 syntheses or guidelines pooled it, 79 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Ab interno trabecular bypass surgery with iStent for open-angle glaucoma.The Cochrane database of systematic reviews · 2019
    Pooled it
  4. Pooled it
  5. Minimally Invasive Glaucoma Surgery: Where Is the Evidence?Asia-Pacific journal of ophthalmology (Philadelphia, Pa.)
    Pooled it
  6. Trial
  7. [Microinvasive glaucoma surgery-Efficacy of trabecular stents in combined interventions : A clinical study on 65 eyes].Der Ophthalmologe : Zeitschrift der Deutschen Ophthalmologischen Gesellschaft · 2019
    Trial
  8. Management and outcomes of primary open-angle glaucoma.Journal of family medicine and primary care · 2026
    Review
  9. Review
  10. Visual Function After Schlemm's Canal-Based MIGS.Journal of clinical medicine · 2025
    Review
  11. Article
  12. Review
  13. Article
  14. Article
  15. Article
  16. iStent for Adults With Glaucoma: A Health Technology Assessment.Ontario health technology assessment series · 2021
    Article
  17. Review
  18. Article
  19. Review
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 7 institutions in 4 countries.

Steven D VoldVold Vision, PLLC, Fayetteville, AR, USA. svold@voldvision.com.
Lilit VoskanyanS.V. Malayan Ophthalmology Centre, Yerevan, Armenia.
Manfred TetzBerlin Eye Research Institute and Augenklinik Spreebogen, Berlin, Germany.
Gerd AuffarthUniversity Hospital Heidelberg, Heidelberg, Germany.
Imran MasoodBirmingham City Hospital, Birmingham, UK.
Leon AuManchester Royal Eye Hospital, Manchester, UK.
Iqbal Ike K AhmedUniversity of Toronto, Toronto, ON, Canada.
Hady SahebMcGill University, Montreal, QC, Canada.
Birmingham City Hospital · GBDRK Kliniken Berlin · DEManchester Royal Eye Hospital · GBMcGill University · CAOphtalmological Center After S.V.Malayan · AMUniversity Hospital Heidelberg · DEUniversity of Toronto · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo examine outcomes through 36 months in phakic eyes with newly diagnosed primary open-angle glaucoma (POAG) naïve to therapy randomized to treatment with two trabecular micro-bypass stents or topical prostaglandin.

methodsSubjects with POAG naïve to therapy, with intraocular pressure (IOP) ≥21 and ≤40 mmHg, were randomized to implantation of two stents or travoprost. Additional medication was to be prescribed post-treatment for elevated IOP or glaucomatous optic nerve findings. Of 101 randomized subjects, 100 subjects were followed for 24 months and 73 subjects were followed for 36 months. Follow-up on all subjects is ongoing.

resultsIn this randomized cohort of 101 POAG subjects, 54 subjects underwent 2-stent surgery and 47 received topical travoprost. Mean pre-treatment IOP was 25.5 ± 2.5 mmHg in stent-treated eyes and 25.1 ± 4.6 mmHg in medication-treated eyes. By 3 years, mean IOP was 14.6 mmHg in stent eyes (with medication added in 6 eyes) and 15.3 mmHg in travoprost eyes (with a second medication added in 11 eyes). In the subset of eyes that did not require additional medical therapy, mean IOP was 14.5 mmHg and 15.7 mmHg in the respective groups. Ninety-one percent of stent eyes had 3-year IOP ≤18 mmHg without additional therapy (62% ≤ 15 mmHg) and 79% of travoprost eyes had 3-year IOP ≤18 mmHg (21% ≤ 15 mmHg). Safety was favorable in both groups.

conclusionsIn this prospective, randomized comparison of subjects with newly diagnosed POAG naïve to therapy, substantial IOP reduction with a favorable low complication rate was shown through 3 years after either 2 trabecular stents implanted as the sole procedure or topical travoprost therapy. These data suggest 2-stent implantation may be a viable initial treatment option comparable to topical prostaglandin in newly diagnosed POAG patients.

trial registrationClinicalTrials.gov identifier, NCT01443988.

fundingGlaukos Corporation, Laguna Hills, CA.

Indexed as

GlaucomaIOPMIGSPOAGProstaglandinTrabecular bypass

Identifiers

PMID27619225
PMCPMC5125126
OpenAlexW2518988485

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.