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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
80
The Dropless will be injected, as a single administration, into the vitreous cavity during the cataract surgery.
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.
CIUSSS de l'Est-de-l'Île-de-Montréal (Hôpital Maisonneuve-Rosemont)
Montreal, Quebec, Canada
McGill Academic Eye Center
Montreal, Quebec, Canada
Cataract surgery - related healthcare resource use assessed by number of relevant medications
Chart abstracted and self-reported by participant
Time frame: 30 to 45 days following each cataract surgeries
Cataract surgery - related healthcare resource use assessed by number of medical visits (outpatient and inpatient visits)
Chart abstracted and self-reported by participant
Time frame: 30 to 45 days following each cataract surgeries
Cataract surgery - related healthcare resource use assessed by number of hospitalizations (ICU and non-ICU)
Chart abstracted and self-reported by participant
Time frame: 30 to 45 days following each cataract surgeries
Cataract surgery - related health care resource use assessed by lengths of hospital stay (ICU and non-ICU)
Chart abstracted and self-reported by participant
Time frame: 30 to 45 days following each cataract surgeries
Cataract surgery - related health care resource use assessed by number of emergency department visit
Chart abstracted and self-reported by participant
Time frame: 30 to 45 days following each cataract surgeries
Cataract surgeries - related health care resource use assessed by number of home visit from nurse
Chart abstracted and self-reported by participant
Time frame: 30 to 45 days following each cataract surgeries
Medication adherence
The investigator will question the participant on his adherence to drop regimen. Descriptive results of the adherence, based on self-reported adherence, will be reported in accordance to patients' responses for each question.
Time frame: 30 to 45 days following each cataract surgeries
Medication satisfaction
The investigator will question the patient in order to describe the satisfaction to drop regimen or Dropless. Descriptive results of the satisfaction, based on self-reported satisfaction, will be reported in accordance to patients' responses for each question.
Time frame: 30 to 45 days following each cataract surgeries
Medication preference
The investigator will question the patient about his preference between the usual care (eye drops) and Dropless. Descriptive results of the preference will be reported in accordance to patients' responses.
Time frame: Through study completion, an average of 20 weeks for each patient
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