ADATO® Silicone Oil is indicated for use as a prolonged retinal tamponade
in selected cases of complicated retinal detachments where other interventions are
not appropriate for patient management. Complicated retinal detachments or recurrent
retinal detachments occur most commonly in eyes with proliferative vitreoretinopathy
(PVR), proliferative diabetic retinopathy (PDR), cytomegalovirus (CMV), retinitis,
giant tears, and following perforating injuries. ADATO Silicone Oil is also indicated
for primary use in detachments due to Acquired Immune Deficiency Syndrome (AIDS)-related
CMV retinitis and other viral infections.
ADATO Silicone Oil is contraindicated in pseudophakic patients with silicone intraocular
lenses (IOLs).
Oil-induced pupillary block and angle closure can occur in aphakic eyes if a six
o'clock iridectomy is not performed.
The use of ADATO Silicone Oil as a long-term tamponade has not been studied and
must be determined by the treating physician. ADATO Silicone Oil should be removed
when, in the judgement of the physician, the retinal attachment would not be compromised.
Adverse events occurring in the highest percentage of patients include cataract,
anterior chamber oil migration, keratopathy, and glaucoma. Other less commonly occurring
adverse events in greater than 2% of patients include redetachment, optic nerve
atrophy, rubeosis iridis, temporary IOP increase, macular pucker, vitreous hemorrhage,
phthisis, traction detachment, and angle block. Complications occurring at rates
of less than 2% include subretinal strands, retinal rupture, endophthalmitis, subretinal
silicone oil, choroidal detachment, aniridia, PVR reproliferation, cystoid macular
edema, and enucleation.