NCT03640650

Economic Impact of Dropless Therapy Versus Usual Care for Cataract Surgery: A Real-World Study.

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: PeriPharm · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This real-life Health Economics and Outcome Research (HEOR) study will enable to evaluate the economic impact of Dropless therapy for the prophylactic treatment of inflammation and infection after routine cataract surgery. This prospective randomized controlled crossover open-label study will estimate resource utilization and cost attributable to patients' management following a cataract surgery and until last follow-up visit and adherence, satisfaction and preference between usual care and Dropless in a real-life setting. Data collected will include patients' characteristics and demographics, medical information, cataract surgery information, healthcare resource utilization, patients' adherence to topical ophthalmic medications as well as patients' satisfaction to both treatment and preference between usual care and Dropless. Patients will fill a set of questionnaires at their recruitment in the study and at their last follow-up visit for their two cataracts surgery.

Conditions

• Cataract Surgery

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Dropless Therapy	The Dropless will be injected, as a single administration, into the vitreous cavity during the cataract surgery.
DRUG	Usual Care	In order to reflect real-world clinical practice, the choice of topical ophthalmic medications as well as dosage, posology, and duration of treatment will be left to the discretion of the treating ophthalmologist.

Timeline

• Start date: 2018-08-15
• Primary completion: 2021-03-16
• Completion: 2021-03-16
• First posted: 2018-08-21
• Last updated: 2021-09-21

Locations

2 sites across 1 country: Canada