Antiacne Medications Pseudotumor Cerebri

Optic Disc Swelling Clinical Trial

— AAMPTC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02149615
• Other study ID #: KEK-ZH 2013-0433 AAMPTC
• Secondary ID: 2013DR4066
• Status: Recruiting
• Phase: Phase 4
• First received: April 7, 2014
• Last updated: May 26, 2014
• Start date: April 2014
• Est. completion date: December 2019

Study information

• Verified date: May 2014
• Source: University of Zurich
• Contact: Gregor Jaggi, MD
• Phone: 0041 44 255 49 00
• Email: gregor.jaggi[@]usz.ch
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 310
• Est. completion date: December 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Antiacne medication treatment indicated by dermatologist

• age > 18 years

• contraception if indicated

Exclusion Criteria:

• age < 18 years

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Edema
• Intracranial Hypertension
• Optic Disc Swelling
• Papilledema
• Pseudotumor Cerebri

Intervention

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

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zurich	ZH

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	University Hospital, Zürich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retinal nerve fibre layer	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.	9 months	No

External Links

•   Study register Switzerland