Efficacy Mydrane ® for Cataract Surgery in Patients With Concomitant Primary Open Angle Glaucoma. (MIGA)
Cataract Surgery
About this trial
This is an interventional treatment trial for Cataract Surgery focused on measuring mydriasis and intraocular anaesthesia
Eligibility Criteria
Inclusion Criteria: patients >18 years of age diagnosed with age-related cataract with concomitant POAG well controlled by pharmacological therapy (IOP within its target during the entire day in a minimum of 12-month follow-up with constant use of anti-glaucoma medications) required cataract extraction under local anesthesia no history of previous surgery in the study eye Exclusion Criteria: patients with POAG requiring glaucoma surgery ocular trauma or infection other forms of glaucoma pseudo-exfoliation and exfoliation syndrome
Sites / Locations
- Policlinico Gemelli
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
Group 1: Mydriatic Eyedrops
Group 2: Insert Device Mydriasert®
Group 3: Intracameral Anesthesia Mydrane®
Group 1 patients included instillation of one drop each of tropicamide 0.5% and phenylephrine 10% ( VISUMIDRIATIC FENILEFRINA) at 30, 20, and 10 min prior to surgery.
Group 2 patients had the Mydriasert® (Phenylephrine Hydrochloride,Tropicamide) device placed in the inferior conjunctival sac at least 1 h before surgery
Group 3 patients received 0.2 mL intracameral Mydrane®(0.2 mg/ml + 3.1 mg/ml + 10 mg/ml tropicamide, lidocaine hydrochloride, phenylephrine hydrochloride) immediately following the clear corneal incision; the surgeon allowed 45-60 s for adequate pupil dilation before performing continuous curvilinear capsulorhexis (CCC)