Acne Cystic, Choroidal Thickness, Dry Eye, Isotretinoin, Retinal Vascularisation
Conditions
Brief summary
The dermatologist created a treatment plan for participants diagnosed with acne using medications containing vitamin A. While this medication has many benefits for the skin, it also has various side effects affecting many other systems. One of the most important of these side effects is related to the eyes. Therefore, the dermatologist will refer participants to an eye clinic for eye exams before and at regular intervals after starting this medication. During these exams, the investigators will perform eye measurements, a dry eye test, and an eye CT scan (OCTA). This study will compare patients who are scheduled to start treatment with vitamin A-containing pills for acne treatment with patients who have started treatment and completed their sixth month. This will allow for the early detection of potential side effects associated with this medication.
Interventions
No different dosage was used compared to other studies. In addition, more ocular layers were examined using imaging techniques to allow for early diagnosis of possible drug-related side effects.
Sponsors
Demet Mutlu
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Being over 18 years of age * Having been diagnosed with cystic acne
Exclusion criteria
* History of glaucoma or ocular hypertension * Prior ocular surgical interventions * Any diagnosed ophthalmic condition, * Refractive errors exceeding 1.00 diopter axial length outside the 22 mm to 24 mm range * Oongoing dry eye therapy * Any systemic/local disorder known to impact retinal or choroidal vascularite or thickness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0 | From enrollment to the end of treatment at 24 weeks | In the participant group receiving treatment for through study completion, any statistically significant change in DVD, SVD, CVD values or Shirmer test scores in OCTA data will be considered a treatment-related side effect. |
Countries
Turkey (Türkiye)
Outcome results
None listed