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Papilledema Outcomes from the Optical Coherence Tomography Substudy of the Idiopathic Intracranial Hypertension Treatment Trial.
Ophthalmology. 2015 Sep; 122(9):1939-45.e2.O

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 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 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.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

26198807

Citation

Optical Coherence Tomography Substudy Committee, and NORDIC Idiopathic Intracranial Hypertension Study Group. "Papilledema Outcomes From the Optical Coherence Tomography Substudy of the Idiopathic Intracranial Hypertension Treatment Trial." Ophthalmology, vol. 122, no. 9, 2015, pp. 1939-45.e2.
Optical Coherence Tomography Substudy Committee, NORDIC Idiopathic Intracranial Hypertension Study Group. Papilledema Outcomes from the Optical Coherence Tomography Substudy of the Idiopathic Intracranial Hypertension Treatment Trial. Ophthalmology. 2015;122(9):1939-45.e2.
Optical Coherence Tomography Substudy Committee. (2015). Papilledema Outcomes from the Optical Coherence Tomography Substudy of the Idiopathic Intracranial Hypertension Treatment Trial. Ophthalmology, 122(9), 1939-e2. https://doi.org/10.1016/j.ophtha.2015.06.003
Optical Coherence Tomography Substudy Committee, NORDIC Idiopathic Intracranial Hypertension Study Group. Papilledema Outcomes From the Optical Coherence Tomography Substudy of the Idiopathic Intracranial Hypertension Treatment Trial. Ophthalmology. 2015;122(9):1939-45.e2. PubMed PMID: 26198807.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Papilledema Outcomes from the Optical Coherence Tomography Substudy of the Idiopathic Intracranial Hypertension Treatment Trial. AU - ,, AU - ,, Y1 - 2015/07/18/ PY - 2014/12/31/received PY - 2015/05/22/revised PY - 2015/06/02/accepted PY - 2015/7/23/entrez PY - 2015/7/23/pubmed PY - 2015/11/17/medline SP - 1939 EP - 45.e2 JF - Ophthalmology JO - Ophthalmology VL - 122 IS - 9 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 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 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. SN - 1549-4713 UR - https://www.unboundmedicine.com/medline/citation/26198807/Papilledema_Outcomes_from_the_Optical_Coherence_Tomography_Substudy_of_the_Idiopathic_Intracranial_Hypertension_Treatment_Trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0161-6420(15)00549-7 DB - PRIME DP - Unbound Medicine ER -