A Phase 4 interventional study of Dropless Therapy and Usual Care in Cataract Surgery, sponsored by PeriPharm. Terminated at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-21.
Sponsored by PeriPharm · Phase 4, Interventional, and Prevention
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.
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's enrollment of 80 is close to the median of 80 across 1,155 interventional studies indexed under Cataract.
Browse Cataract studies →PeriPharm is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Single used, pre-mixed, centrally compounded injectable that contains 15 mg/ml of triamcinolone acetonide and 1 mg/ml of moxifloxacin. This preservative-free suspension is injected at a dose of 0.2 mg into the posterior chamber, for a total drug delivery of 3 mg of triamcinolone acetonide and 0.2 mg of moxifloxacin. At the time of cataract surgery, Dropless is intended to be injected as a single administration into the anterior vitreous after the insertion of the IOL implant, with a 27 or 30-gauge cannula via a transzonular or transsceral pars plana injection, just before rinsing the viscoelastic fluid.
Combination Product: Dropless Therapy
This therapy usually comprises an antibiotic, a steroid and in some cases a nonsteroidal anti-inflammatory drug (NSAID). Antibacterial drops are usually given at the end of surgery and are continued for one week after the surgery. Steroid drops are usually started the day of surgery and then tapered down over 3 to 4 weeks. When prescribed, NSAIDs are usually started 2 or 3 days before surgery, or started the day of surgery, and continued for 3 or 4 times a day for 3 to 4 weeks.
Drug: Usual Care
The Dropless will be injected, as a single administration, into the vitreous cavity during the cataract surgery.
Also known as: Triamcinolone acetonide (15mg/ml), Moxifloxacine (1mg/ml)
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.
Also known as: Antibacterial eye drops, Nonsteroidal anti-inflammatory eye drops, Steroid eye drops
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
Plan to share: No
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This study is terminated, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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