SKIACOL (cyclopentolate), antocholinergic eye drops

High clinical benefit in cycloplegia before refraction measurements, but no demonstrated clinical advantage in the therapeutic strategy

Insufficient clinical benefit to justify reimbursement in the other indications due to the absence of role in the therapeutic strategy

• SKIACOL has been granted an MA in adults and children ≥ 1 year for cycloplegia and mydriasis before refraction measurements, diagnosis of post-surgical esotropia and preoperative dilation for cataract or photocoagulation.

• Its use is established and recommended in cycloplegia before refraction measurements.

• Its administration regimen is simpler and less restrictive than that of atropine to achieve cycloplegia.

• The impact on morbidity and mortality and on quality of life has not as yet been demonstrated due to the lack of clinical data.

• Considering its more frequent adverse effects compared to other mydriatic eye drops, SKIACOL has no role in the therapeutic strategy for achieving mydriasis prior to refraction measurements, post-surgical esotropia diagnosis and achievement of preoperative dilation for cataract and photocoagulation.