Clinical trial NCT03640650: Economic Impact of Dropless Therapy Versus Usual Care for Cataract Surgery: A Real-World Study.
Official title: Economic Impact of Dropless Therapy Versus Usual Care for Cataract Surgery: A Real-World Study.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Cataract Surgery
Keywords: Sequential bilateral cataract surgery
Lead sponsor: PeriPharm
Sponsor class: OTHER
Collaborators: name: Advance Dosage Forms, Inc.
name: Imprimis Pharmaceuticals, Inc.
First posted: 2018-08-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. 18 years of age or older;
2. Undergoing delayed sequential bilateral cataract extraction with intraocular lens implantation;
3. Delayed sequential bilateral cataract surgery performed in a day surgery setting;
4. Second cataract surgery planned within 3 months following the date of the first cataract surgery;
5. Ability to read and understand English or French;
6. Signature of ICF.

Exclusion Criteria:

1. Patients with other ophthalmic conditions such as glaucoma, corneal disease, agerelated macular degeneration, and active uveitis\* (\*In line with current clinical practice in Canada, uveitis should be inactive for 3 months to be included in the study);
2. Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation;
3. Participation in any investigational ophthalmic-related drug or device trial within the 30 days prior to the start date of this trial or participation in any current investigational ophthalmic-related drug or device trial;
4. Patients with any history of allergy to the usual care post-operative eye drops or the components of Dropless.

Primary outcomes:
measure: Cataract surgery - related healthcare resource use assessed by number of relevant medications
timeFrame: 30 to 45 days following each cataract surgeries
measure: Cataract surgery - related healthcare resource use assessed by number of medical visits (outpatient and inpatient visits)
timeFrame: 30 to 45 days following each cataract surgeries
measure: Cataract surgery - related healthcare resource use assessed by number of hospitalizations (ICU and non-ICU)
timeFrame: 30 to 45 days following each cataract surgeries
measure: Cataract surgery - related health care resource use assessed by lengths of hospital stay (ICU and non-ICU)
timeFrame: 30 to 45 days following each cataract surgeries
measure: Cataract surgery - related health care resource use assessed by number of emergency department visit
timeFrame: 30 to 45 days following each cataract surgeries
measure: Cataract surgeries - related health care resource use assessed by number of home visit from nurse
timeFrame: 30 to 45 days following each cataract surgeries
Secondary outcomes:
measure: Medication adherence
timeFrame: 30 to 45 days following each cataract surgeries
measure: Medication satisfaction
timeFrame: 30 to 45 days following each cataract surgeries
measure: Medication preference
timeFrame: Through study completion, an average of 20 weeks for each patient
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: CIUSSS de l'Est-de-l'Île-de-Montréal (Hôpital Maisonneuve-Rosemont)
state: Quebec
city: Montreal
country: Canada
facility: McGill Academic Eye Center
state: Quebec
Study officials:
References: