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OphthalmologyJuly 201569 citations

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


AI Summary

Acetazolamide and weight loss effectively reduce papilledema-related optic nerve swelling in IIH patients, as measured by OCT, offering objective treatment monitoring for this condition.

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.


MeSH Terms

AcetazolamideCarbonic Anhydrase InhibitorsDouble-Blind MethodFollow-Up StudiesHumansNerve FibersPapilledemaProspective StudiesPseudotumor CerebriRetinaRetinal Ganglion CellsTomography, Optical CoherenceTreatment OutcomeVisual Field TestsWeight Loss

Key Concepts5

In the Idiopathic Intracranial Hypertension Treatment Trial (IIHTT), the acetazolamide group showed a greater reduction in retinal nerve fiber layer (RNFL) thickness (175 μm) compared to the placebo group (89 μm) at 6 months (P = 0.001) in subjects with mild visual loss due to idiopathic intracranial hypertension.

TreatmentRCTRandomized double-masked control clinical trialn=89 subjects (43 acetazolamide treated…Ch5Ch28

In the Idiopathic Intracranial Hypertension Treatment Trial (IIHTT), the acetazolamide group demonstrated a greater reduction in total retinal thickness (TRT) (220 μm) compared to the placebo group (113 μm) at 6 months (P = 0.001) in subjects with mild visual loss due to idiopathic intracranial hypertension.

TreatmentRCTRandomized double-masked control clinical trialn=89 subjects (43 acetazolamide treated…Ch5Ch28

In the Idiopathic Intracranial Hypertension Treatment Trial (IIHTT), the acetazolamide group exhibited a greater reduction in optic nerve head (ONH) volume (4.9 mm^3) compared to the placebo group (2.1 mm^3) at 6 months (P = 0.001) in subjects with mild visual loss due to idiopathic intracranial hypertension.

TreatmentRCTRandomized double-masked control clinical trialn=89 subjects (43 acetazolamide treated…Ch5Ch28

In the Idiopathic Intracranial Hypertension Treatment Trial (IIHTT), subjects who lost 6% or more of their study entry weight showed smaller increases in retinal nerve fiber layer (RNFL) thickness (P = 0.01), total retinal thickness (TRT) (P = 0.003), and optic nerve head (ONH) volume (P = 0.002) measurements, indicating improvement in papilledema.

TreatmentRCTRandomized double-masked control clinical trialn=89 subjects (43 acetazolamide treated…Ch5Ch28

In the Idiopathic Intracranial Hypertension Treatment Trial (IIHTT), retinal nerve fiber layer (RNFL) thickness, total retinal thickness (TRT), and optic nerve head (ONH) volume measurements showed moderate correlations (r = 0.48-0.59; P ≤ 0.0001) with Frisén grade, a clinical papilledema grading method.

DiagnosisRCTRandomized double-masked control clinical trialn=89 subjects (43 acetazolamide treated…Ch5

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