XXXX Outcomes from the Optical Coherence Tomography Substudy of the @entity5576 Treatment Trial.

@entity1 @entity227 @entity5494 @entity3791 @entity4 @entity1829 @entity989 @entity5576
PURPOSE: To assess treatment efficacy using spectral-domain (SD) optical coherence tomography (OCT) measurements of @entity1829 in the @entity5576 Treatment Trial (IIHTT), which evaluated the effects of @entity3791 and weight management and of placebo and weight management in eyes with mild @entity227 . DESIGN: Randomized double-masked control clinical trial of @entity3791 plus weight management compared with placebo plus weight management in subjects with mild @entity227 and previously untreated @entity5576 ( @entity5576 ). @entity1 : Eighty-nine (43 @entity3791 treated, 46 placebo treated) of 165 subjects meeting IIHTT entry criteria. METHODS: Subjects underwent perimetry, @entity1829 grading (Fris  n method), high- and low-contrast visual acuity, and SD OCT imaging at study entry and 3 and 6 months. Study eye results (worse @entity5494 [ @entity5494 ]) were used for most analyses. MAIN OUTCOME MEASURES: Retinal nerve fiber layer (RNFL) thickness, total retinal thickness (TRT), optic nerve (ONH) volume, and @entity989 ( @entity989 ) measurements derived using 3-dimensional segmentation. RESULTS: Study entry OCT values were similar in both treatment groups. At 6 months, the @entity3791 group had greater reduction than the placebo group for RNFL thickness (175  m vs. 89  m; P  = 0.001), TRT (220  m vs. 113  m; P  = 0.001), and ONH volume (4.9 mm(3) vs. 2.1 mm(3); P  = 0.001). The RNFL thickness (P  = 0.01), TRT (P  = 0.003), and ONH volume (P  = 0.002) measurements also showed smaller increases in subjects who lost 6% or more of study entry weight. The @entity3791 (3.6  m) and placebo (2.1  m) groups showed minor @entity989 thinning (P  = 0.06). The RNFL thickness, TRT, and ONH volume measurements showed moderate correlations (r  = 0.48-0.59; P  <= 0.0001) with Fris  n grade. The 14 eyes with @entity989 thickness less than the fifth percentile of controls had worse @entity5494 (P  = 0.001) than study eyes with @entity989 in the fifth percentile or more. CONCLUSIONS: In @entity5576 , @entity3791 and weight loss effectively improve RNFL thickness, TRT, and ONH @entity4 measurements resulting from @entity1829 . In contrast to the strong correlation at baseline, OCT measures at 6 months show only moderate correlations with @entity1829 grade.
