Comparison of treatment with the steroid anti-inflammatory loteprednol etabonate and the non-steroidal anti-inflammatory drug (NSAID) bromfenac after cataract surgery.
- Conditions
- Cataract surgeryEye Diseases
- Registration Number
- ISRCTN70915202
- Lead Sponsor
- Department of Ophthalmology, Norbert Barlicki Memorial Teaching Hospital No. 1, Medical University of Lodz
- Brief Summary
2019 results in: https://doi.org/10.5114/ko.2019.84564 (added 07/11/2019)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 58
1. Patients with age-related cataract undergoing phacoemulsification with posterior chamber intraocular lens (PC IOL) implantation. Patients having uneventful phacoemulsification with PC IOL implantation were enrolled.
2. BCVA between 0.1 and 0.5
3. Cataract nuclear sclerosis in the range between II and III according to LOCS III scale
4. No anti-inflammatory medication for 2 weeks prior to cataract surgery
5. No allergy to loteprednol etabonate (LE) or bromfenac
6. Aged 45-90 years
Patients with ocular infection, glaucoma, uveitis, diabetes, pseudoexfoliation syndrome, prior ocular trauma or intraocular surgery, corneal diseases, ocular tumors, optic nerve atrophy, autoimmune diseases, endocrine, renal, neurological, psychiatric disorders were excluded from the study.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Intraocular inflammation assessed by laser flare photometry using Kowa FM -600 (Kowa Co. Ltd). Seven laser flare photometry measurements with values greater than 0 and which backgrounds differed less than 15% were saved. For all patients the highest and the lowest values of flare were excluded, according to the manufacturer’s guidelines. The remaining 5 measurements were averaged. All measurements were taken with undilated pupils.<br> The follow-up examinations were performed on the first day and 1, 4, and 12 weeks postoperatively. Measurements were done at the same time of the day on scheduled visits.<br>
- Secondary Outcome Measures
Name Time Method <br> 1. Best corrected visual acuity (BCVA) on the Snellen chart<br> 2. Intraocular pressure<br> 3. Anterior and posterior segment evaluation<br> 4. Foveal retina thickness using Optical Coherence Tomography (Topcon 3D OCT-1000 Mark II and Zeiss Stratus OCT Version 4.0.5 (0076)<br> 5. Endothelial cell density measured with Tomey EM-3000 and Topcon SP 2000P Confocal Microscope<br> The follow-up examinations were performed on the first day and 1, 4, and 12 weeks postoperatively. Measurements were done at the same time of the day on scheduled visits.<br>