Antiacne Medications Pseudotumor Cerebri

Phase 4

• Conditions: Optic Disc Swelling
• Interventions: Other: Retinal nerve fibre layer measurement

• Registration Number: NCT02149615
• Lead Sponsor: University of Zurich

Brief Summary

The exact incidence of optic disc swelling and idiopathic intracranial hypertension in patients using antiacne medication is not known so far. The investigators hypothesize that swelling of retinal nerve fibre layer measured by optical coherence tomography is more frequent then assumed so far.

Detailed Description

Measurement of retinal nerve fibre layer using optical coherence tomography over a period of 6 to 9 months depending on exact antiacne medication.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-07
• Status Verified: 2014-05
• Study First Submitted QC: 2014-05-26
• Last Update Submitted: 2014-05-26
• Study First Posted: 2014-05-29
• Last Update Posted: 2014-05-29
• Primary Completion: 2019-04
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 310

Inclusion Criteria

• Antiacne medication treatment indicated by dermatologist
• age > 18 years
• contraception if indicated

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Exclusion Criteria

• age < 18 years

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
isotretinoin	Retinal nerve fibre layer measurement	Retinal nerve fibre layer measurement in patients under isotretinoin treatment
lymecycline	Retinal nerve fibre layer measurement	Retinal nerve fibre layer measurement in patients under lymecycline treatment
minocycline	Retinal nerve fibre layer measurement	Retinal nerve fibre layer measurement in patients under minocycline treatment
doxycycline	Retinal nerve fibre layer measurement	Retinal nerve fibre layer measurement in patients under doxycycline treatment

Primary Outcome Measures

Name	Time	Method
Retinal nerve fibre layer	9 months	Measurement of retinal nerve fibre layer using optical coherence tomography. Changes over 10 micrometers are considered to be clinically relevant.; The Term "retinal nerve fibre layer" describes an automated standardized optical coherence tomography measurement program measuring the sectorial thickness of the peripapillar retinal nerve fibre layer. There exists no other term for that.

Trial Locations

Locations (1)

University Hospital Zurich; 🇨🇭 Zurich, ZH, Switzerland