Comparison of the post-operative regime of topical medication in uncomplicated Phacoemulsification at 2 weeks and 6 weeks
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Dr Shambhavi Jhobta
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Reduction in the post operative duration of topical medication from 6 weeks to 2 weeks.
Overview
Brief Summary
This study is an interventional, single blind, randomized parallel group control trial that will be conducted in Indira Gandhi Medical College and Hospital, Shimla, H.P., India, comparing the cure rates of post-operative regime of topical medication ( Moxifloxacin 0.5% + Prednisolone1% ) at 2 weeks and 6 weeks in cataract patients undergoing uncomplicated Phacoemulsification. The study duration will be 1year (9 months of data collection and 3 months of data compilation and report writing). The primary end point will be the reduction in the post operative duration of topical medication from 6 weeks to 2 weeks. The secondary outcomes will be lesser postoperative side effects like secondary glaucoma, delayed healing and antibacterial resistance and better patient compliance.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 45.00 Year(s) to 95.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Patients with cataract undergoing uncomplicated surgery (Phacoemulsification).
- •Patients who give consent.
Exclusion Criteria
- •1.Patients with previous corneal disease, corneal trauma, or intraocular surgery.
- •Patients who had communication problems (short of hearing, language barriers, dementia, etc.).
- •Patients with glaucoma or uveitis
- •Patients with Diabetic Retinopathy, Hypertensive Retinopathy or any other macular disease
- •Use of ocular medication during or within 30 days prior to the enrollment.
- •Use of steroid during the study or within 14 days prior to enrollment.
- •Systemic diseases that can interfere with the results of the study (e.g., rheumatoid arthritis, Sjögren’s syndrome, Behçet’s disease, systemic lupus erythematosus, scleroderma with major ocular involvement, etc.);.
Outcomes
Primary Outcomes
Reduction in the post operative duration of topical medication from 6 weeks to 2 weeks.
Time Frame: 2 weeks
Secondary Outcomes
- 1.Lesser postoperative side effects like secondary glaucoma, delayed healing & antibacterial resistance.(2. Better patient compliance)
Investigators
Dr Shambhavi Jhobta
Indira Gandhi Medical College and Hospital