Papilledema Outcomes from the Optical Coherence Tomography Substudy of the Idiopathic Intracranial Hypertension Treatment Trial

Peggy Auinger, Mary Durbin, Steven Feldon, Mona Garvin, Randy Kardon, John Keltner, Mark Kupersmith, Patrick Sibony, Kim Plumb, Jui Kai Wang, John S. Werner

Research output: Contribution to journalArticle

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Abstract

Purpose To assess treatment efficacy using spectral-domain (SD) optical coherence tomography (OCT) measurements of papilledema in the Idiopathic Intracranial Hypertension Treatment Trial (IIHTT), which evaluated the effects of acetazolamide and weight management and of placebo and weight management in eyes with mild visual loss. Design Randomized double-masked control clinical trial of acetazolamide plus weight management compared with placebo plus weight management in subjects with mild visual field loss and previously untreated idiopathic intracranial hypertension (IIH). Participants Eighty-nine (43 acetazolamide treated, 46 placebo treated) of 165 subjects meeting IIHTT entry criteria. Methods Subjects underwent perimetry, papilledema grading (Frisén method), high- and low-contrast visual acuity, and SD OCT imaging at study entry and 3 and 6 months. Study eye results (worse perimetric mean deviation [PMD]) were used for most analyses. Main Outcome Measures Retinal nerve fiber layer (RNFL) thickness, total retinal thickness (TRT), optic nerve (ONH) volume, and retinal ganglion cell layer (RGCL) measurements derived using 3-dimensional segmentation. Results Study entry OCT values were similar in both treatment groups. At 6 months, the acetazolamide group had greater reduction than the placebo group for RNFL thickness (175 μm vs. 89 μm; P = 0.001), TRT (220 μm vs. 113 μm; P = 0.001), and ONH volume (4.9 mm3 vs. 2.1 mm3; 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 acetazolamide (3.6 μm) and placebo (2.1 μm) groups showed minor RGCL thinning (P = 0.06). The RNFL thickness, TRT, and ONH volume measurements showed moderate correlations (r = 0.48-0.59; P ≤ 0.0001) with Frisén grade. The 14 eyes with RGCL thickness less than the fifth percentile of controls had worse PMD (P = 0.001) than study eyes with RGCL in the fifth percentile or more. Conclusions In IIH, acetazolamide and weight loss effectively improve RNFL thickness, TRT, and ONH volume swelling measurements resulting from papilledema. In contrast to the strong correlation at baseline, OCT measures at 6 months show only moderate correlations with papilledema grade.

Original languageEnglish (US)
Pages (from-to)1939-1945
Number of pages7
JournalOphthalmology
Volume122
Issue number9
DOIs
StatePublished - Sep 1 2015

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Pseudotumor Cerebri
Papilledema
Acetazolamide
Optical Coherence Tomography
Nerve Fibers
Retinal Ganglion Cells
Placebos
Weights and Measures
Therapeutics
Visual Field Tests
Optic Nerve
Visual Fields
Visual Acuity
Weight Loss
Outcome Assessment (Health Care)
Clinical Trials

ASJC Scopus subject areas

  • Ophthalmology

Cite this

Papilledema Outcomes from the Optical Coherence Tomography Substudy of the Idiopathic Intracranial Hypertension Treatment Trial. / Auinger, Peggy; Durbin, Mary; Feldon, Steven; Garvin, Mona; Kardon, Randy; Keltner, John; Kupersmith, Mark; Sibony, Patrick; Plumb, Kim; Wang, Jui Kai; Werner, John S.

In: Ophthalmology, Vol. 122, No. 9, 01.09.2015, p. 1939-1945.

Research output: Contribution to journalArticle

Auinger, P, Durbin, M, Feldon, S, Garvin, M, Kardon, R, Keltner, J, Kupersmith, M, Sibony, P, Plumb, K, Wang, JK & Werner, JS 2015, 'Papilledema Outcomes from the Optical Coherence Tomography Substudy of the Idiopathic Intracranial Hypertension Treatment Trial', Ophthalmology, vol. 122, no. 9, pp. 1939-1945. https://doi.org/10.1016/j.ophtha.2015.06.003
Auinger, Peggy ; Durbin, Mary ; Feldon, Steven ; Garvin, Mona ; Kardon, Randy ; Keltner, John ; Kupersmith, Mark ; Sibony, Patrick ; Plumb, Kim ; Wang, Jui Kai ; Werner, John S. / Papilledema Outcomes from the Optical Coherence Tomography Substudy of the Idiopathic Intracranial Hypertension Treatment Trial. In: Ophthalmology. 2015 ; Vol. 122, No. 9. pp. 1939-1945.
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abstract = "Purpose To assess treatment efficacy using spectral-domain (SD) optical coherence tomography (OCT) measurements of papilledema in the Idiopathic Intracranial Hypertension Treatment Trial (IIHTT), which evaluated the effects of acetazolamide and weight management and of placebo and weight management in eyes with mild visual loss. Design Randomized double-masked control clinical trial of acetazolamide plus weight management compared with placebo plus weight management in subjects with mild visual field loss and previously untreated idiopathic intracranial hypertension (IIH). Participants Eighty-nine (43 acetazolamide treated, 46 placebo treated) of 165 subjects meeting IIHTT entry criteria. Methods Subjects underwent perimetry, papilledema grading (Fris{\'e}n method), high- and low-contrast visual acuity, and SD OCT imaging at study entry and 3 and 6 months. Study eye results (worse perimetric mean deviation [PMD]) were used for most analyses. Main Outcome Measures Retinal nerve fiber layer (RNFL) thickness, total retinal thickness (TRT), optic nerve (ONH) volume, and retinal ganglion cell layer (RGCL) measurements derived using 3-dimensional segmentation. Results Study entry OCT values were similar in both treatment groups. At 6 months, the acetazolamide group had greater reduction than the placebo group for RNFL thickness (175 μm vs. 89 μm; P = 0.001), TRT (220 μm vs. 113 μm; P = 0.001), and ONH volume (4.9 mm3 vs. 2.1 mm3; 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 acetazolamide (3.6 μm) and placebo (2.1 μm) groups showed minor RGCL 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{\'e}n grade. The 14 eyes with RGCL thickness less than the fifth percentile of controls had worse PMD (P = 0.001) than study eyes with RGCL in the fifth percentile or more. Conclusions In IIH, acetazolamide and weight loss effectively improve RNFL thickness, TRT, and ONH volume swelling measurements resulting from papilledema. In contrast to the strong correlation at baseline, OCT measures at 6 months show only moderate correlations with papilledema grade.",
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T1 - Papilledema Outcomes from the Optical Coherence Tomography Substudy of the Idiopathic Intracranial Hypertension Treatment Trial

AU - Auinger, Peggy

AU - Durbin, Mary

AU - Feldon, Steven

AU - Garvin, Mona

AU - Kardon, Randy

AU - Keltner, John

AU - Kupersmith, Mark

AU - Sibony, Patrick

AU - Plumb, Kim

AU - Wang, Jui Kai

AU - Werner, John S.

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N2 - Purpose To assess treatment efficacy using spectral-domain (SD) optical coherence tomography (OCT) measurements of papilledema in the Idiopathic Intracranial Hypertension Treatment Trial (IIHTT), which evaluated the effects of acetazolamide and weight management and of placebo and weight management in eyes with mild visual loss. Design Randomized double-masked control clinical trial of acetazolamide plus weight management compared with placebo plus weight management in subjects with mild visual field loss and previously untreated idiopathic intracranial hypertension (IIH). Participants Eighty-nine (43 acetazolamide treated, 46 placebo treated) of 165 subjects meeting IIHTT entry criteria. Methods Subjects underwent perimetry, papilledema grading (Frisén method), high- and low-contrast visual acuity, and SD OCT imaging at study entry and 3 and 6 months. Study eye results (worse perimetric mean deviation [PMD]) were used for most analyses. Main Outcome Measures Retinal nerve fiber layer (RNFL) thickness, total retinal thickness (TRT), optic nerve (ONH) volume, and retinal ganglion cell layer (RGCL) measurements derived using 3-dimensional segmentation. Results Study entry OCT values were similar in both treatment groups. At 6 months, the acetazolamide group had greater reduction than the placebo group for RNFL thickness (175 μm vs. 89 μm; P = 0.001), TRT (220 μm vs. 113 μm; P = 0.001), and ONH volume (4.9 mm3 vs. 2.1 mm3; 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 acetazolamide (3.6 μm) and placebo (2.1 μm) groups showed minor RGCL thinning (P = 0.06). The RNFL thickness, TRT, and ONH volume measurements showed moderate correlations (r = 0.48-0.59; P ≤ 0.0001) with Frisén grade. The 14 eyes with RGCL thickness less than the fifth percentile of controls had worse PMD (P = 0.001) than study eyes with RGCL in the fifth percentile or more. Conclusions In IIH, acetazolamide and weight loss effectively improve RNFL thickness, TRT, and ONH volume swelling measurements resulting from papilledema. In contrast to the strong correlation at baseline, OCT measures at 6 months show only moderate correlations with papilledema grade.

AB - Purpose To assess treatment efficacy using spectral-domain (SD) optical coherence tomography (OCT) measurements of papilledema in the Idiopathic Intracranial Hypertension Treatment Trial (IIHTT), which evaluated the effects of acetazolamide and weight management and of placebo and weight management in eyes with mild visual loss. Design Randomized double-masked control clinical trial of acetazolamide plus weight management compared with placebo plus weight management in subjects with mild visual field loss and previously untreated idiopathic intracranial hypertension (IIH). Participants Eighty-nine (43 acetazolamide treated, 46 placebo treated) of 165 subjects meeting IIHTT entry criteria. Methods Subjects underwent perimetry, papilledema grading (Frisén method), high- and low-contrast visual acuity, and SD OCT imaging at study entry and 3 and 6 months. Study eye results (worse perimetric mean deviation [PMD]) were used for most analyses. Main Outcome Measures Retinal nerve fiber layer (RNFL) thickness, total retinal thickness (TRT), optic nerve (ONH) volume, and retinal ganglion cell layer (RGCL) measurements derived using 3-dimensional segmentation. Results Study entry OCT values were similar in both treatment groups. At 6 months, the acetazolamide group had greater reduction than the placebo group for RNFL thickness (175 μm vs. 89 μm; P = 0.001), TRT (220 μm vs. 113 μm; P = 0.001), and ONH volume (4.9 mm3 vs. 2.1 mm3; 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 acetazolamide (3.6 μm) and placebo (2.1 μm) groups showed minor RGCL thinning (P = 0.06). The RNFL thickness, TRT, and ONH volume measurements showed moderate correlations (r = 0.48-0.59; P ≤ 0.0001) with Frisén grade. The 14 eyes with RGCL thickness less than the fifth percentile of controls had worse PMD (P = 0.001) than study eyes with RGCL in the fifth percentile or more. Conclusions In IIH, acetazolamide and weight loss effectively improve RNFL thickness, TRT, and ONH volume swelling measurements resulting from papilledema. In contrast to the strong correlation at baseline, OCT measures at 6 months show only moderate correlations with papilledema grade.

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