This is a non-interventional, uncontrolled, prospective, multicenter, post marketing surveillance study.
The study treatment i.e., 0.5% Moxifloxacin hydrochloride ophthalmic solution will be prescribed as per approved label; the assignment of the patient to the therapy will be decided within the current practice and the medical indication and will clearly be separated from the decision to include the patient in the study. The treatment period for each patient will be maximum 17 days from start of Moxifloxacin treatment. Study visit will be 1 day prior to surgery, day of surgery (Day 0) and 1 (day of surgery / post surgery), 7, and 14 days post-op (Note: Since its non-interventional study, the eligibility confirmation can be 1 or 2 days prior to the surgery depending on investigator's discretion). After the patients sign the informed consent, the patients will be advised to start with Moxifloxacin ophthalmic solutions 2 days prior to the surgery and will be advised to administer it 5 times a day. On the Day 0, day of the surgery, the patient will be instilled 1 drop of Moxifloxacin in the eye which will be operated prior to surgery and 1 drop twice post surgery. From Day 1 post surgery, patient will have 1 drop of Moxifloxacin instilled three times a day up to Day 14 (14 days after surgery). If there are any signs and symptoms of endophthalmitis, then at the investigator's discretion, Gram Stain \& Culture assessment of aqueous \& vitreous fluid may be performed post surgery on Days 1, 7, and 14.
Study Type
OBSERVATIONAL
Enrollment
102
Prospective observational study. There is no treatment allocation. Patients prescribed with 0.5% Moxifloxacin hydrochloride ophthalmic solution during the perioperative period of ophthalmic surgery are eligible to enroll into this study.
Novartis Investigative Site
Ahmedabad, Gujarat, India
Novartis Investigative Site
Ahmedabad, Gujarat, India
Novartis Investigative Site
Kochi, Kerala, India
Novartis Investigative Site
Nagpur, Maharashtra, India
Post-op endophthalmitis rate up to Day 14
The post-op endophthalmitis rate = (No of patients in whom endophthalmitis occurred in post-op period up to Day 14/ no of enrolled patients) X 100
Time frame: Up to Day 14 after surgery
Number of patients with diagnosis of suspected endophthalmitis using microbiological culture and Gram stain of aqueous and vitreous fluids
Number of patients with diagnosis of suspected endophthalmitis using microbiological culture and Gram stain of aqueous and vitreous fluids to be collected
Time frame: Day 1, Day 7, Day 14 after surgery
Number of patients assessed for infection using 4 clinical signs post-surgery
To assess for infection using 4 clinical signs post-surgery: 1. Drop in vision 2. Pain and redness 3. Swelling 4. Purulent discharge It will be recorded and measured as present or absent.
Time frame: Day 1, Day 7, Day 14 after surgery
Number and proportion of patients with ocular adverse events (AEs) after surgery
Number and proportion of patients with ocular adverse events (AEs) after surgery to be collected
Time frame: Up to Day 16 after surgery
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Novartis Investigative Site
Chennai, Tamil Nadu, India
Novartis Investigative Site
Varanasi, Uttar Pradesh, India
Novartis Investigative Site
Kolkata, West Bengal, India
Novartis Investigative Site
Kolkata, West Bengal, India
Novartis Investigative Site
Delhi, India