Antiacne Medications Pseudotumor Cerebri

Overview

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.

Full Title of Study: “Prospective Open-label Phase IV Trial to Investigate the Frequency of Optic Disc Swelling, Idiopathic Intracranial Hypertension and Dry Eye Symptoms Under Antiacne Medication Treatment”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2019

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.

Interventions

  • Other: Retinal nerve fibre layer measurement
    • Measurement of retinal nerve fibre layer thickness using optic coherence tomography.

Arms, Groups and Cohorts

  • Experimental: isotretinoin
    • Retinal nerve fibre layer measurement in patients under isotretinoin treatment
  • Active Comparator: lymecycline
    • Retinal nerve fibre layer measurement in patients under lymecycline treatment
  • Active Comparator: minocycline
    • Retinal nerve fibre layer measurement in patients under minocycline treatment
  • Active Comparator: doxycycline
    • Retinal nerve fibre layer measurement in patients under doxycycline treatment

Clinical Trial Outcome Measures

Primary Measures

  • Retinal nerve fibre layer
    • Time Frame: 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.

Participating in This Clinical Trial

Inclusion Criteria

  • Antiacne medication treatment indicated by dermatologist – age > 18 years – contraception if indicated Exclusion Criteria:

  • age < 18 years

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Zurich
  • Collaborator
    • University Hospital, Zürich
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Klara Landau, Prof MD, Study Chair, UniversityHospital, Zurich
  • Overall Contact(s)
    • Gregor Jaggi, MD, 0041 44 255 49 00, gregor.jaggi@usz.ch

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