Evidence map›Paper›PMID 25764482›Full record

Trial reportJAMA ophthalmology2015

Vision-Related Quality-of-Life Outcomes in the Mycotic Ulcer Treatment Trial I: A Randomized Clinical Trial.

Jennifer Rose-Nussbaumer, N Venkatesh Prajna, K Tiruvengada Krishnan, Jeena Mascarenhas, Revathi Rajaraman, Muthiah Srinivasan, Anita Raghavan, Catherine E Oldenburg, Kieran S O'Brien, Kathryn J Ray and 6 more

Registry-linked trialOpen access · greenAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in JAMA ophthalmology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00996736 (Mycotic Ulcer Treatment Trial), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 25% 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.

NCT00996736 phase3completednot on this map

Mycotic Ulcer Treatment Trial

TypeinterventionalSponsorUniversity of California, San FranciscoRan2010 to 2012Enrolled323ConditionsCorneal Ulcer, Eye Infections, FungalArmsNatamycin, Voriconazole
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
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

16 authors at 3 institutions in 2 countries.

Jennifer Rose-NussbaumerFrancis I. Proctor Foundation, University of California, San Francisco2Department of Ophthalmology, University of California, San Francisco3Department of Optometry, University of California, Berkeley.
N Venkatesh PrajnaAravind Eye Care System, Madurai, India5Aravind Eye Care System, Pondicherry, India6Aravind Eye Care System, Coimbatore, India.
K Tiruvengada KrishnanAravind Eye Care System, Madurai, India5Aravind Eye Care System, Pondicherry, India6Aravind Eye Care System, Coimbatore, India.
Jeena MascarenhasAravind Eye Care System, Madurai, India5Aravind Eye Care System, Pondicherry, India6Aravind Eye Care System, Coimbatore, India.
Revathi RajaramanAravind Eye Care System, Madurai, India5Aravind Eye Care System, Pondicherry, India6Aravind Eye Care System, Coimbatore, India.
Muthiah SrinivasanAravind Eye Care System, Madurai, India5Aravind Eye Care System, Pondicherry, India6Aravind Eye Care System, Coimbatore, India.
Anita RaghavanAravind Eye Care System, Madurai, India5Aravind Eye Care System, Pondicherry, India6Aravind Eye Care System, Coimbatore, India.
Catherine E OldenburgFrancis I. Proctor Foundation, University of California, San Francisco.
Kieran S O'BrienFrancis I. Proctor Foundation, University of California, San Francisco.
Kathryn J RayFrancis I. Proctor Foundation, University of California, San Francisco.
Stephen D McLeodDepartment of Ophthalmology, University of California, San Francisco.
Travis C PorcoFrancis I. Proctor Foundation, University of California, San Francisco2Department of Ophthalmology, University of California, San Francisco7Department of Epidemiology and Biostatistics, University of California, San Francisco.
Thomas M LietmanFrancis I. Proctor Foundation, University of California, San Francisco2Department of Ophthalmology, University of California, San Francisco7Department of Epidemiology and Biostatistics, University of California, San Francisco.
Nisha R AcharyaFrancis I. Proctor Foundation, University of California, San Francisco2Department of Ophthalmology, University of California, San Francisco.
Jeremy D KeenanFrancis I. Proctor Foundation, University of California, San Francisco2Department of Ophthalmology, University of California, San Francisco.
Mycotic Ulcer Treatment Trial I Group
University of California, San Francisco · USAravind Eye Hospital · INSan Francisco Foundation · US

Funding

Myocotic Ulcer Treatment TrialU10EY018573 · NEI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI LIETMAN, THOMAS M · 2009 to 2014
$3.7M
Predictions of Response to Treatment in Fungal KeratitisK23EY025025 · NEI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI ROSE-NUSSBAUMER, JENNIFER · 2015 to 2019
$1.2M
NEI NIH HHS K23 EY025025NEI NIH HHS U10 EY018573NEI NIH HHS U10-EY018573-01A1
6 · The paper itself

Abstract

importanceGiven the limitations in health care resources, quality-of-life measures for interventions have gained importance.

objectiveTo determine whether vision-related quality-of-life outcomes were different between the natamycin and voriconazole treatment arms in the Mycotic Ulcer Treatment Trial I, as measured by an Indian Vision Function Questionnaire. DESIGN, SETTING, AND

participantsSecondary analysis (performed October 11-25, 2014) of a double-masked, multicenter, randomized, active comparator-controlled, clinical trial at multiple locations of the Aravind Eye Care System in South India that enrolled patients with culture- or smear-positive filamentous fungal corneal ulcers who had a baseline visual acuity of 20/40 to 20/400 (logMAR of 0.3-1.3).

interventionsStudy participants were randomly assigned to topical voriconazole, 1%, or topical natamycin, 5%. MAIN OUTCOMES AND MEASURES: Subscale score on the Indian Vision Function Questionnaire from each of the 4 subscales (mobility, activity limitation, psychosocial impact, and visual function) at 3 months.

resultsA total of 323 patients were enrolled in the trial, and 292 (90.4%) completed the Indian Vision Function Questionnaire at 3 months. The majority of study participants had subscale scores consistent with excellent function. After adjusting for baseline visual acuity and organism, we found that study participants in the natamycin-treated group scored, on average, 4.3 points (95% CI, 0.1-8.5) higher than study participants in the voriconazole-treated group (P = .046). In subgroup analyses looking at ulcers caused by Fusarium species and adjusting for baseline best spectacle-corrected visual acuity, the natamycin-treated group scored 8.4 points (95% CI, 1.9-14.9) higher than the voriconazole-treated group (P = .01). Differences in quality of life were not detected for patients with Aspergillus or other non-Fusarium species as the causative organism (1.5 points [95% CI, -3.9 to 6.9]; P = .52). CONCLUSIONS AND RELEVANCE: We found evidence of improvement in vision-related quality of life among patients with fungal ulcers who were randomly assigned to natamycin compared with those randomly assigned to voriconazole, and especially among patients with Fusarium species as the causative organism. Incorporation of quality-of-life measures in clinical trials is important to fully evaluate the effect of the studied interventions.

trial registrationclinicaltrials.gov Identifier:NCT00996736.

Indexed as

Administration, TopicalAdultAgedAntifungal AgentsCorneal UlcerDouble-Blind MethodEye Infections, FungalFemaleFungiHumansMaleMiddle AgedMycosesNatamycinOphthalmic SolutionsQuality of LifeAntifungal AgentsNatamycinOphthalmic SolutionsVoriconazole

Identifiers

PMID25764482
PMCPMC4962866
OpenAlexW2020907114

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.