Ocular Microbiology and Immunology Group
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2014 OMIG Abstract 11

Visual Function Questionnaire Outcomes in the Mycotic Ulcer Treatment Trial:
a Randomized Trial Comparing Natamycin to Voriconazole
Jennifer Rose-Nussbaumer, MD¹; N Venkatesh Prajna MD², Tiruvengada Krishnan MD²,
Jeena Mascarenhas MD², Revathi Rajaraman MD², Muthiah Srinivasan MD², Anita Raghavan MD²,
Catherine E Oldenburg MPH¹, Kieran O’Brien MPH¹, Kathryn J Ray MA¹, Stephen D Mcleod MD³,
Travis C Porco PhD MPH^3,4, Thomas M Lietman MD^1,4, Nisha R Acharya MD MS¹,
Jeremy Keenan MD MPH¹ for the Mycotic Ulcer Treatment Trial Group
¹Francis I. Proctor Foundation, ²Aravind Eye Care System at Madurai, Pondicherry and Coimbatore
³UCSF Department of Ophthalmology, University of California San Francisco
⁴UCSF Epidemiology and Biostatistics, University of California San Francisco

Purpose: To determine whether quality of life outcomes were different between the natamycin and voriconazole treatment arms in the Mycotic Ulcer Treatment Trial I (MUTT I), as measured by Indian Visual Function Questionnaire (IND-VFQ).

Methods: Data were collected as part of MUTT I, a NEI-funded double-masked, multicenter, randomized controlled trial. Study participants with smear positive filamentous fungal corneal ulcers and a baseline visual acuity of 20/40 to 20/400 were randomized to topical 1% voriconazole versus topical 5% natamycin. As a secondary analysis, the IND-VFQ was administered at 3 months. IND-VFQ subscale scores including mobility, activity limitation, psychosocial impact and visual function were compared between treatment groups using linear regression and controlling for baseline best spectacle-corrected visual acuity. Subgroup analysis looking at IND-VFQ subscale scores in Fusarium and Aspergillus ulcers was also performed.

Results: 323 patients were enrolled in the trial, and 292 (90.4%) completed the IND-VFQ at 3 months. There was no evidence of differential loss to follow up between the treatment arms. The majority of study participants had raw subscale scores consistent with excellent function. After adjusting for baseline visual acuity, study participants scored on average 2.08 points higher on the mobility scale (95% CI -1.77 – 5.39, P = 0.29), 2.70 points higher on the activity limitation (95% CI -0.9-6.29, P = 0.14), 6.05 points higher on the psychosocial impact scale (95% CI 0.22 – 11.87, P = 0.04) and 5.75 points higher on the visual function subscale (95% CI 0.48 -11.03, P = 0.03) in the natamycin treated group. Among Fusarium ulcers, the natamycin-treated group scored 6.5 points higher on the mobility subscale (95% CI 0.53– 12.5, P = 0.03), 6.3 points higher on the activity limitation score (95% CI 0.62 -11.9, P = 0.03), 12 points higher on psychosocial impact score (95% CI 2.9 – 21.0, P = 0.01), and 9.0 points higher on visual symptoms score (95% CI 0.01 – 17.8, P = 0.05), after adjusting for baseline BSCVA. None of these differences reached statistical significance after Holm-Šidák correction for multiple comparisons. Differences in quality of life were not present for patients with Aspergillus ulcers.

Conclusion: Although not statistically significant, we found some evidence of improvement in quality of life scores among fungal ulcer patients randomized to natamycin compared with those treated with voriconazole, especially among Fusarium ulcers. Incorporation of quality of life metrics in clinical trials is important to fully evaluate the impact of the studied interventions.

Disclosure: N
ClinicalTrials.gov Identifier NCT00997035; NIH funding U10-EY018573-01A1

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