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Antiacne Medications Pseudotumor Cerebri

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02149615
Acronym
AAMPTC
Enrollment
310
Registered
2014-05-29
Start date
2014-04-30
Completion date
2019-12-31
Last updated
2014-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Optic Disc Swelling

Keywords

idiopathic intracranial hypertension, optic disc swelling, antiacne medication, isotretinoin

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.

Interventions

OTHERRetinal nerve fibre layer measurement

Measurement of retinal nerve fibre layer thickness using optic coherence tomography.

Sponsors

University Hospital, Zürich
CollaboratorOTHER
University of Zurich
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

\- age \< 18 years

Design outcomes

Primary

MeasureTime frameDescription
Retinal nerve fibre layer9 monthsMeasurement 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.

Countries

Switzerland

Contacts

Primary ContactGregor Jaggi, MD
gregor.jaggi@usz.ch0041 44 255 49 00
Backup ContactIsabelle Meneau
isabelle@meneau@usz.ch

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026