Antiacne Medications Pseudotumor Cerebri

Study Overview
=================
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.

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

Conditions
-----------------
Optic Disc Swelling

Intervention / Treatment
-----------------
* Other: Retinal nerve fibre layer measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Antiacne medication treatment indicated by dermatologist age > 18 years contraception if indicated Exclusion Criteria: - age < 18 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: isotretinoin<br>Retinal nerve fibre layer measurement in patients under isotretinoin treatment | Other: Retinal nerve fibre layer measurement<br>* Measurement of retinal nerve fibre layer thickness using optic coherence tomography.<br>* Other names: effect of medication on optic nerve fibre layer;|
| Active Comparator: lymecycline<br>Retinal nerve fibre layer measurement in patients under lymecycline treatment | Other: Retinal nerve fibre layer measurement<br>* Measurement of retinal nerve fibre layer thickness using optic coherence tomography.<br>* Other names: effect of medication on optic nerve fibre layer;|
| Active Comparator: minocycline<br>Retinal nerve fibre layer measurement in patients under minocycline treatment | Other: Retinal nerve fibre layer measurement<br>* Measurement of retinal nerve fibre layer thickness using optic coherence tomography.<br>* Other names: effect of medication on optic nerve fibre layer;|
| Active Comparator: doxycycline<br>Retinal nerve fibre layer measurement in patients under doxycycline treatment | Other: Retinal nerve fibre layer measurement<br>* Measurement of retinal nerve fibre layer thickness using optic coherence tomography.<br>* Other names: effect of medication on optic nerve fibre layer;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
idiopathic intracranial hypertension, optic disc swelling, antiacne medication, isotretinoin