TY - JOUR
T1 - Validation of a photographic vitreous haze grading technique for clinical trials in uveitis
AU - Madow, Brian
AU - Galor, Anat
AU - Feuer, William J.
AU - Altaweel, Michael M.
AU - Davis, Janet L.
N1 - Funding Information:
Publication of this article was Supported by an unrestricted grant from Research to Prevent Blindness, Inc , New York, New York, to the University of Miami. The contribution of the Multicenter Uveitis Steroid Treatment (MUST) Trial Research Group to the manuscript was supported by cooperative agreements from the National Eye Institute to Mount Sinai School of Medicine (U10 EY 014655), The Johns Hopkins University Bloomberg School of Public Health (U10 EY 014660), and the University of Wisconsin, Madison, School of Medicine (U10 EY 014656). Bausch & Lomb also provided a limited allotment of fluocinolone acetonide 0.59-mg implants for patients randomized to implant treatment in the study who could not afford that treatment. Clinical trial identifier number ( NCT00132691 ). Dr Altaweel receives consulting fees from Glaxo-Smith-Kline and grant support from NEI and Pfizer ; Dr Davis receives consulting fees and grant support from Centocor and Novartis ; Dr Feuer receives grant support from the National Institutes of Health Center Grant P30-EY14801 ; Dr Madow is on the Advisory Board for Eyetech and has equity interest in Regeneron. Involved in design and conduct of study (J.L.D., B.M., M.M.A.); collection and management of data (J.L.D., B.M., W.J.F., and the 23 MUST trial clinical centers); analysis and interpretation of data (J.L.D., B.M., W.J.F., A.G.); preparation and review of article (J.L.D., B.M., W.J.F., A.G.); and approval of manuscript (all authors and the MUST Trial Executive Committee). The University of Miami Miller School Human Subjects Research Board reviewed and approved this study. MUST clinical trial sites and the MUST trial coordinating center received approval from their respective institutional review boards to collect photographs and clinical data. The MUST trial and this study were conducted in accordance with the Declaration of Helsinki. Dr Namrata Kapoor, Dr Ryan Rush, and Dr Brian Madow graded the MUST trial photographs using the photographic vitreous haze grader. The credit roster of the members of the Multicenter Uveitis Steroid Treatment Trial Research Group has been published previously. 6
PY - 2011/8
Y1 - 2011/8
N2 - Purpose: To validate a photographic vitreous haze grading technique using a 9-step logarithmic scale in patients enrolled in a randomized, controlled clinical trial in uveitis. Design: Retrospective study of clinical trials methodology. Methods: Setting: University-based department of ophthalmology. Study population: Baseline fundus photographs of patients with intermediate uveitis, posterior uveitis, or panuveitis enrolled in the Multicenter Uveitis Steroid Treatment (MUST) trial. Observational procedure: Grading of vitreous haze using a previously described photographic scale. Regrading of a subset of photographs to assess intraobserver agreement. Main outcome measures: Interobserver and intraobserver intraclass correlation for photographic haze grading, and correlation between photographic and clinical vitreous haze scores, assessment of the clinical findings that significantly affect the photographic haze score. Results: Vitreous haze was graded in 271 eyes (142 patients) by 3 postgraduate ophthalmologists. The interobserver and intraobserver intraclass correlations were excellent, with correlation coefficients between 0.84 and 0.93. There was moderately strong correlation between the photographic and clinical vitreous haze scores (r = 0.51; P <.001), with significant differences among the mean and median photographic haze scores for the 3 lowest clinical grades of haze, 0, 1+, and 2+. Other parameters that correlated with photographic vitreous haze score included visual acuity of 20/50 or worse (P =.003), degrees of posterior synechiae (P <.001), lens abnormality (P =.023) or posterior capsule obscuration (P =.001), and amount of anterior vitreous cell (P =.002). Conclusions: Photographic grading of vitreous haze with a 9-step logarithmic scale is a highly reproducible methodology that may be adaptable to use in future clinical trials.
AB - Purpose: To validate a photographic vitreous haze grading technique using a 9-step logarithmic scale in patients enrolled in a randomized, controlled clinical trial in uveitis. Design: Retrospective study of clinical trials methodology. Methods: Setting: University-based department of ophthalmology. Study population: Baseline fundus photographs of patients with intermediate uveitis, posterior uveitis, or panuveitis enrolled in the Multicenter Uveitis Steroid Treatment (MUST) trial. Observational procedure: Grading of vitreous haze using a previously described photographic scale. Regrading of a subset of photographs to assess intraobserver agreement. Main outcome measures: Interobserver and intraobserver intraclass correlation for photographic haze grading, and correlation between photographic and clinical vitreous haze scores, assessment of the clinical findings that significantly affect the photographic haze score. Results: Vitreous haze was graded in 271 eyes (142 patients) by 3 postgraduate ophthalmologists. The interobserver and intraobserver intraclass correlations were excellent, with correlation coefficients between 0.84 and 0.93. There was moderately strong correlation between the photographic and clinical vitreous haze scores (r = 0.51; P <.001), with significant differences among the mean and median photographic haze scores for the 3 lowest clinical grades of haze, 0, 1+, and 2+. Other parameters that correlated with photographic vitreous haze score included visual acuity of 20/50 or worse (P =.003), degrees of posterior synechiae (P <.001), lens abnormality (P =.023) or posterior capsule obscuration (P =.001), and amount of anterior vitreous cell (P =.002). Conclusions: Photographic grading of vitreous haze with a 9-step logarithmic scale is a highly reproducible methodology that may be adaptable to use in future clinical trials.
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U2 - 10.1016/j.ajo.2011.01.058
DO - 10.1016/j.ajo.2011.01.058
M3 - Article
C2 - 21652026
AN - SCOPUS:79960844085
VL - 152
SP - 170-176.e1
JO - American Journal of Ophthalmology
JF - American Journal of Ophthalmology
SN - 0002-9394
IS - 2
ER -