Evidence map›Paper›PMID 28302532›Full record

Trial reportAmerican journal of ophthalmology2017

Randomized Controlled Crossover Trial Comparing the Impact of Sham or Intranasal Tear Neurostimulation on Conjunctival Goblet Cell Degranulation.

Koray Gumus, Karri L Schuetzle, Stephen C Pflugfelder

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in American journal of ophthalmology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06525961 (A Single-center, Open-label, Single-arm Study to Evaluate the Effectiveness and Safety of Extra Nasal Neurostimulator in Patients With Dry Eye Disease Dissatisfied With Artificial Tears), which is not on this map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
5.0field-weighted citation impact, top 5% 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.

NCT06525961 phase4unknown statusnot on this mapstarted 2024, after this paper: background citation

A Single-center, Open-label, Single-arm Study to Evaluate the Effectiveness and Safety of Extra Nasal Neurostimulator in Patients With Dry Eye Disease Dissatisfied With Artificial Tears

TypeinterventionalSponsorThe University of Hong KongRan2024 to 2026Enrolled30ConditionsDry Eye Disease, Dry Eye Syndromes, Dry Eye, Meibomian Gland DysfunctionArmsiTEAR100 Neurostimulator
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 54 citations in OpenAlex.

  1. Trial
  2. Novel Extranasal Tear Stimulation: Pivotal Study Results.Translational vision science & technology · 2020
    Trial
  3. Electrotherapy in the management of neuropathic corneal pain: narrative review.Experimental biology and medicine (Maywood, N.J.) · 2026
    Review
  4. Article
  5. Review
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Advances in dry eye disease treatment.Current opinion in ophthalmology · 2019
    Review
  14. Review
  15. [Novel current and future therapy options for treatment of dry eye disease].Der Ophthalmologe : Zeitschrift der Deutschen Ophthalmologischen Gesellschaft · 2018
    Review
  16. Review
  17. 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

3 authors at 2 institutions in 2 countries.

Koray GumusCullen Eye Institute, Baylor College of Medicine, Houston, Texas; Erciyes University School of Medicine, Department of Ophthalmology, Kayseri, Turkey.
Karri L SchuetzleCullen Eye Institute, Baylor College of Medicine, Houston, Texas.
Stephen C PflugfelderCullen Eye Institute, Baylor College of Medicine, Houston, Texas. Electronic address: stevenp@bcm.edu.
Baylor College of Medicine · USErciyes University · TR

Funding

VISION RESEARCH CENTERP30EY002520 · NEI · BAYLOR COLLEGE OF MEDICINE · PI Samuel M Wu · 1985 to 2026
$14.8M
NEI NIH HHS P30 EY002520
6 · The paper itself

Abstract

purposeThe aim of the study was to investigate the effects of the Allergan Intranasal Tear Neurostimulator (ITN) on conjunctival goblet cell (GC) degranulation.

designA randomized, double-masked, placebo-controlled crossover trial.

methodsA total of 15 subjects (5 normal and 10 dry eye) were enrolled in a 3-visit study consisting of 1 screening and 2 separate randomized-masked ITN treatments (sham extranasal or intranasal). Tear meniscus height (TMH) was measured by anterior segment optical coherence tomography before and after applications. Impression cytology (IC) was taken from the bulbar conjunctiva of the right eye for periodic acid-Schiff staining and from the left eye for MUC5AC mucin immunostaining at baseline and after each treatment. The ratio of degranulated to nondegranulated GCs was measured as a marker of secretion.

resultsIn all participants, both inferior bulbar (IB) and temporal bulbar (TB) cytology specimens stained for MUC5AC revealed a significantly higher ratio of degranulated to nondegranulated GCs after the ITN (IB: 2.28 ± 1.27 and TB: 1.81 ± 1.01) compared to baseline (IB: 0.56 ± 0.55, P = .015) (TB: 0.56 ± 0.32, P = .003) and extranasal sham application (IB: 0.37 ± 0.29, P = .001) (TB: 0.39 ± 0.33, P = .001). When the same analysis was repeated in the dry eye or control groups, the ratio was significantly higher after ITN than the baseline ratio and ratio after extranasal application in both groups (P < .05). Moreover, although control subjects had a higher ratio of degranulated to nondegranulated GCs at baseline (0.75 ± 0.52) compared with the dry eye group (0.41 ± 0.27), the ratio became slightly higher in dry eye (2.04 ± 1.12 vs 1.99 ± 1.21 in control) after the ITN application. There was no significant difference between the IB or TB conjunctiva locations in terms of the effectiveness of the ITN application on conjunctival goblet cell secretory response.

conclusionsThese preliminary results document that the Allergan ITN can stimulate degranulation of goblet cells in the conjunctiva, which is a promising new approach for the management of dry eye.

Indexed as

Administration, IntranasalAdultCell DegranulationConjunctivaCross-Over StudiesDry Eye SyndromesFemaleGoblet CellsHumansLubricant Eye DropsMaleMiddle AgedTearsTomography, Optical CoherenceLubricant Eye Drops

Identifiers

PMID28302532
PMCPMC5457166
OpenAlexW2596272934

What OpenQuestion holds

Textmetadata
LicenceTDM
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.