Conditions: Cataract
Keywords: PCIOL CCI CE
Allocation: RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 80
Healthy volunteers: yes

Brief summary:
To assess the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert in the operating room following cataract surgery/intraocular lens implant (IOL) with or without iStent/Hydrus/Goniotomy when placed in the lower punctum compared to the upper punctum.

Detailed description:
This is a randomized, controlled study to evaluate the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert in the operating room following cataract surgery/intraocular lens implant (IOL) with or without iStent/Hydrus/Goniotomy when placed in the lower punctum compared to the upper punctum.

Arms:
arm 1: DEXTENZA (dexamethasone ophthalmic insert, 0.4mg) for intracanalicular use

Group 1 (up to 40 eyes) will receive the insert in the lower punctum on the day of surgery in the OR. arm 2: DEXTENZA (dexamethasone ophthalmic insert, 0.4mg) for intracanalicular use

Group 2 (up to 40 eyes) will receive the insert in the upper punctum on the of surgery in the OR.

Interventions: intervention 1: Dextenza 0.4Mg Ophthalmic Insert
Intervention descriptions: intervention 1: (dexamethasone ophthalmic insert)-for the treatment of ocular inflammation and pain following following ophthalmic surgery.

Protocol document:
Prot_SAP_000.pdf: