Evidence map›Paper›PMID 26189353›Full record

Trial reportBiology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation2015

Bandage Soft Contact Lenses for Ocular Graft-versus-Host Disease.

Yoshihiro Inamoto, Yi-Chen Sun, Mary E D Flowers, Paul A Carpenter, Paul J Martin, Peng Li, Ruikang Wang, Xiaoyu Chai, Barry E Storer, Tueng T Shen and 1 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01616056 (A Single Center Phase II Study of Bandage Lenses for Ocular Graft-Versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation), which is not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
5.3field-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.

NCT01616056 phase2completednot on this map

A Single Center Phase II Study of Bandage Lenses for Ocular Graft-Versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation

TypeinterventionalSponsorFred Hutchinson Cancer CenterRan2012 to 2014Enrolled20ConditionsGraft Versus Host Disease, Ophthalmologic ComplicationsArmsgraft versus host disease prophylaxis/therapy, questionnaire administration, optical coherence tomography
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 49 citations in OpenAlex.

  1. Pooled it
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  10. Detection of systemic immunosuppressants in autologous serum eye drops (ASED) in patients with severe chronic ocular graft versus host disease.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2021
    Article
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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

11 authors at 2 institutions in 1 country.

Yoshihiro InamotoDivision of Clinical Research, Fred Hutchinson Cancer Research Center, Seattle, Washington. Electronic address: yinamoto@fhcrc.org.
Yi-Chen SunDepartment of Ophthalmology, University of Washington, Seattle, Washington.
Mary E D FlowersDivision of Clinical Research, Fred Hutchinson Cancer Research Center, Seattle, Washington.
Paul A CarpenterDivision of Clinical Research, Fred Hutchinson Cancer Research Center, Seattle, Washington.
Paul J MartinDivision of Clinical Research, Fred Hutchinson Cancer Research Center, Seattle, Washington.
Peng LiDepartment of Bioengineering, University of Washington, Seattle, Washington.
Ruikang WangDepartment of Ophthalmology, University of Washington, Seattle, Washington; Department of Bioengineering, University of Washington, Seattle, Washington.
Xiaoyu ChaiDivision of Clinical Research, Fred Hutchinson Cancer Research Center, Seattle, Washington.
Barry E StorerDivision of Clinical Research, Fred Hutchinson Cancer Research Center, Seattle, Washington.
Tueng T ShenDepartment of Ophthalmology, University of Washington, Seattle, Washington; Department of Bioengineering, University of Washington, Seattle, Washington.
Stephanie J LeeDivision of Clinical Research, Fred Hutchinson Cancer Research Center, Seattle, Washington.
Fred Hutch Cancer Center · USUniversity of Washington · US

Funding

Training and Career Development CoreU54CA163438 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI LEE, STEPHANIE J · 2011 to 2014
$3.7M
NCI NIH HHS U54 CA163438
6 · The paper itself

Abstract

To examine safety and efficacy of bandage soft contact lenses (BSCLs) for ocular chronic graft-versus host disease (GVHD), we conducted a phase II clinical trial. Extended-wear BSCLs were applied under daily topical antibiotic prophylaxis. Patients completed standardized symptom questionnaires at enrollment and at 2 weeks, 4 weeks, and 3 months afterward. Ophthalmologic assessment was performed at enrollment, at 2 weeks, and afterward as medically needed. Assessments at follow-up were compared with baseline by paired t-test. Nineteen patients with ocular GVHD who remained symptomatic despite conventional treatments were studied. The mean Lee eye subscale score was 75.4 at enrollment and improved significantly to 63.2 at 2 weeks (P = .01), to 61.8 at 4 weeks (P = .005), and to 56.3 at 3 months (P = .02). The ocular surface disease index score and 11-point eye symptom ratings also improved significantly. According to the Lee eye subscale, clinically meaningful improvement was observed in 9 patients (47%) at 2 weeks, in 11 patients (58%) at 4 weeks, and in 9 patients (47%) at 3 months. Visual acuity improved significantly at 2 weeks compared with enrollment values. Based on slit lamp exam at 2 weeks, punctate epithelial erosions improved in 58% of the patients, showed stability in 16%, and worsened in 5%. No corneal ulceration or ocular infection occurred. BSCLs are a widely available, safe, and effective treatment option that improves manifestations of ocular GVHD in approximately 50% of patients. This study was registered at www.clinicaltrials.gov as NCT01616056.

Indexed as

Contact Lenses, HydrophilicHematopoietic Stem Cell TransplantationTransplantation ConditioningAdultAgedAnti-Bacterial AgentsEyeEye DiseasesFemaleGraft vs Host DiseaseHematologic NeoplasmsHumansMaleMiddle AgedMyeloablative AgonistsOphthalmoscopyAnti-Bacterial AgentsMyeloablative AgonistsContact lensDry eye diseaseGraft-versus-host diseaseHematopoietic cell transplantationTreatment

Identifiers

PMID26189353
PMCPMC4604037
OpenAlexW2152560896

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.