title: Vision-Related Quality-of-Life Outcomes in the Mycotic Ulcer Treatment Trial I: A Randomized Clinical Trial.
abstract: OBJECTIVE
  Given the limitations in health care resources, quality-of-life measures for interventions have gained importance.
  
  
  OBJECTIVE
  To 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.
  
  
  METHODS
  Secondary 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).
  
  
  METHODS
  Study participants were randomly assigned to topical voriconazole, 1%, or topical natamycin, 5%.
  
  
  METHODS
  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.
  
  
  RESULTS
  A 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
  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.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier:NCT00996736.
authors.affiliation: Francis I. Proctor Foundation, University of California, San Francisco2Department of Ophthalmology, University of California, San Francisco3Department of Optometry, University of California, Berkeley.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Rose-Nussbaumer
authors.affiliation: Aravind Eye Care System, Madurai, India5Aravind Eye Care System, Pondicherry, India6Aravind Eye Care System, Coimbatore, India.
authors.forename: N Venkatesh
authors.initials: NV
authors.lastname: Prajna
authors.affiliation: Aravind Eye Care System, Madurai, India5Aravind Eye Care System, Pondicherry, India6Aravind Eye Care System, Coimbatore, India.
authors.forename: K Tiruvengada
authors.initials: KT
authors.lastname: Krishnan
authors.affiliation: Aravind Eye Care System, Madurai, India5Aravind Eye Care System, Pondicherry, India6Aravind Eye Care System, Coimbatore, India.
authors.forename: Jeena
authors.initials: J
authors.lastname: Mascarenhas
authors.affiliation: Aravind Eye Care System, Madurai, India5Aravind Eye Care System, Pondicherry, India6Aravind Eye Care System, Coimbatore, India.
authors.forename: Revathi
authors.initials: R
authors.lastname: Rajaraman
authors.affiliation: Aravind Eye Care System, Madurai, India5Aravind Eye Care System, Pondicherry, India6Aravind Eye Care System, Coimbatore, India.
authors.forename: Muthiah
authors.initials: M
authors.lastname: Srinivasan
authors.affiliation: Aravind Eye Care System, Madurai, India5Aravind Eye Care System, Pondicherry, India6Aravind Eye Care System, Coimbatore, India.
authors.forename: Anita
authors.initials: A
authors.lastname: Raghavan
authors.affiliation: Francis I. Proctor Foundation, University of California, San Francisco.
authors.forename: Catherine E
authors.initials: CE
authors.lastname: Oldenburg
authors.affiliation: Francis I. Proctor Foundation, University of California, San Francisco.
authors.forename: Kieran S
authors.initials: KS
authors.lastname: O'Brien
authors.affiliation: Francis I. Proctor Foundation, University of California, San Francisco.
authors.forename: Kathryn J
authors.initials: KJ
authors.lastname: Ray
authors.affiliation: Department of Ophthalmology, University of California, San Francisco.
authors.forename: Stephen D
authors.initials: SD
authors.lastname: McLeod
authors.affiliation: Francis I. Proctor Foundation, University of California, San Francisco2Department of Ophthalmology, University of California, San Francisco7Department of Epidemiology and Biostatistics, University of California, San Francisco.
authors.forename: Travis C
authors.initials: TC
authors.lastname: Porco
authors.affiliation: Francis I. Proctor Foundation, University of California, San Francisco2Department of Ophthalmology, University of California, San Francisco7Department of Epidemiology and Biostatistics, University of California, San Francisco.
authors.forename: Thomas M
authors.initials: TM
authors.lastname: Lietman
authors.affiliation: Francis I. Proctor Foundation, University of California, San Francisco2Department of Ophthalmology, University of California, San Francisco.
authors.forename: Nisha R
authors.initials: NR
authors.lastname: Acharya
authors.affiliation: Francis I. Proctor Foundation, University of California, San Francisco2Department of Ophthalmology, University of California, San Francisco.
authors.forename: Jeremy D
authors.initials: JD
authors.lastname: Keenan
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000935:Antifungal Agents / Q000627:therapeutic use*; D003320:Corneal Ulcer / Q000188:drug therapy* / Q000382:microbiology / Q000523:psychology; D004311:Double-Blind Method; D015821:Eye Infections, Fungal / Q000188:drug therapy* / Q000382:microbiology / Q000523:psychology; D005260:Female; D005658:Fungi / Q000302:isolation & purification; D006801:Humans; D008297:Male; D008875:Middle Aged; D009181:Mycoses / Q000188:drug therapy* / Q000382:microbiology / Q000523:psychology; D010866:Natamycin / Q000627:therapeutic use; D009883:Ophthalmic Solutions; D011788:Quality of Life / Q000523:psychology*; D018434:Sickness Impact Profile; D011795:Surveys and Questionnaires; D014785:Vision, Ocular / Q000502:physiology*; D014792:Visual Acuity / Q000502:physiology; D065819:Voriconazole / Q000627:therapeutic use
chemical_list: D000935:Antifungal Agents; D009883:Ophthalmic Solutions; D010866:Natamycin; D065819:Voriconazole