Health Condition 1: H28- Cataract in diseases classified elsewhere
Conditions
Interventions
Intervention1: Moxifloxacin-Dexamethasone: Moxifloxacin-Dexamethasone Ophthalmic Solution.
one drop from a labeled bottle of moxifloxacin 4 times a day on day âË?â??1 (1 day before the surgery) and a
Sponsors
Aristopharma Ltd
Eligibility
Inclusion criteria
Inclusion criteria: i. All patients with cataract who have consented for cataract surgery. ii. Patients with controlled diabetes mellitus. iii. Age: adult patients (above 18 years). iv. Patients agree to participate in this study. v. Patients who have no known hypersensitive reaction to moxifloxacin and dexamethasone. vi. Patients are not using ocular antimicrobial drugs within 30 days of enrollment. vii. Patients are not using topical or systemic steroids or nonsteroidal anti-inflammatory drugs (NSAIDs) and immunosuppressive therapy in the 14 days before enrollment. vii. Patients are not suffering from any terminal illness. viii. Patients have not proliferative diabetic retinopathy, or moderately severe non-proliferative diabetic retinopathy. ix. Patients have not active inflammation on slit-lamp biomicroscopy or history of chronic or recurrent ocular inflammatory diseases (i.e., iritis, scleritis, uveitis, iridocyclitis, and rubeosis iridis), significant ocular pain and iris atrophy. x. Patients with controlled glaucoma or ocular hypertension. xi. Patients have not active epithelial herpes simplex, vaccinia, chicken pox, corneal or conjunctival disease, ocular tuberculosis or fungal disease. xii. Patients have not any severe systemic disease or condition that made self-treatment with eye drops difficult. xiii. Non-pregnant and non-lactating mothers. xiv. Patients are not receiving a topical prostaglandin for IOP control within 4 days prior to surgery. xv. Patients are not with complicated cataracts such as traumatic or subluxated. xvi. Patients are not with severe thyroid disease.
Exclusion criteria
Exclusion criteria: i. Patients with uncontrolled diabetes mellitus, proliferative diabetic retinopathy, or moderately severe non-proliferative diabetic retinopathy. ii. Age: below 18 years. iii. Patients are using topical or systemic steroids or nonsteroidal anti-inflammatory drugs (NSAIDs) and immunosuppressive therapy in the 14 days before enrollment. iv. Patients are using ocular antimicrobial drugs within 30 days of enrollment. v. Patients with active inflammation on slit-lamp biomicroscopy or history of chronic or recurrent ocular inflammatory diseases (i.e., iritis, scleritis, uveitis, iridocyclitis, and rubeosis iridis), significant ocular pain and iris atrophy. vi. Patients with uncontrolled glaucoma or ocular hypertension. vii. Patients who have known hypersensitive reaction to moxifloxacin and dexamethasone. viii. Patients with active epithelial herpes simplex, vaccinia, chicken pox, corneal or conjunctival disease, ocular tuberculosis or fungal disease. ix. Patients with any severe systemic disease or condition that made self-treatment with eye drops difficult. x. Patients with sight in a single. xi. Pregnant and lactating mothers. xii. Patients are receiving a topical prostaglandin for IOP control within 4 days prior to surgery. xiii. Patients with complicated cataracts such as traumatic or subluxated. xiv. Patients will have combined operations with cataract surgery such as trabeculectomy or a corneal graft. xv. Patients with severe thyroid disease. xvi. Patients with open infection anywhere, infection of lacrimal drainage channels or infection around the eye. xvii. Patients wearing contact lens during study. xviii. Patients having secondary implantation or IOL replacement in the treated eye, or wore contact lenses. xviii. Patients refuse to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prevention of post-operative endophthalmitis following phacoemulsification cataract surgery in Bangladesh due to post-operative use of combined formulation of moxifloxacin and dexamethasone.Timepoint: Day 0, 08, 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of endophthalmitis in Bangladesh following phacoemulsification cataract surgery in Bangladesh. [Time frame: Day 0, 08, 15] 2. Incidence of adverse drug events due to medication of moxifloxacin and dexamethasone. [Time frame: Day 0, 08, 15] 3. Incidence of other post-operative complications following phacoemulsification in Bangladesh. [Time frame: Day 0, 08, 15] Timepoint: Day 0, 08, 15 | — |
Countries
Bangladesh
Contacts
Public ContactAbu Syed Md Mosaddek
Uttara Adhunik Medical College
Outcome results
None listed