Cataract Surgery
Conditions
Keywords
Sequential bilateral cataract surgery
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.
Interventions
COMBINATION_PRODUCTDropless Therapy
The Dropless will be injected, as a single administration, into the vitreous cavity during the cataract surgery.
DRUGUsual 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.
Sponsors
Advance Dosage Forms, Inc.
Imprimis Pharmaceuticals, Inc.
PeriPharm
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cataract surgeries - related health care resource use assessed by number of home visit from nurse | 30 to 45 days following each cataract surgeries | Chart abstracted and self-reported by participant |
| Cataract surgery - related healthcare resource use assessed by number of hospitalizations (ICU and non-ICU) | 30 to 45 days following each cataract surgeries | Chart abstracted and self-reported by participant |
| Cataract surgery - related health care resource use assessed by lengths of hospital stay (ICU and non-ICU) | 30 to 45 days following each cataract surgeries | Chart abstracted and self-reported by participant |
| Cataract surgery - related health care resource use assessed by number of emergency department visit | 30 to 45 days following each cataract surgeries | Chart abstracted and self-reported by participant |
| Cataract surgery - related healthcare resource use assessed by number of relevant medications | 30 to 45 days following each cataract surgeries | Chart abstracted and self-reported by participant |
| Cataract surgery - related healthcare resource use assessed by number of medical visits (outpatient and inpatient visits) | 30 to 45 days following each cataract surgeries | Chart abstracted and self-reported by participant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medication satisfaction | 30 to 45 days following each cataract surgeries | 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. |
| Medication preference | Through study completion, an average of 20 weeks for each patient | 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. |
| Medication adherence | 30 to 45 days following each cataract surgeries | 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. |
Countries
Canada
Outcome results
None listed