Cataract, Pseudoexfoliation Syndrome
Conditions
Brief summary
OBJECTIVE To evaluate the efficacy of bromfenac ophthalmic solution 0.09% for reducing postoperative inflammation in eyes with pseudoexfoliation syndrome (PEX) undergoing cataract surgery and receiving standard postoperative eye drops (dexamethasone 0.1% plus tobramycin 0.3% ophthalmic solution). DESIGN Two arms, parallel group, randomized, single center, prospective, phase IV clinical trial. PARTICIPANTS Sixty-two subjects with PEX and cataract will be sequentially assigned, according to a computer-generated randomization list (1:1), to bromfenac (n = 31) or not (n = 31). INTERVENTION Cataract surgery by means of phacoemulsification and implantation of posterior-chamber intraocular lens will be performed by two experienced ophthalmic surgeons. Standard Arm: only a standard antibiotic and steroid ophthalmic suspension will be given starting the day after the surgery for two weeks, dosed QID for the first week and BID for the second week (dexamethasone 0.1% and tobramycin 0.3% eye drops association). Experimental Arm: eyes will receive bromfenac BID for two weeks starting the day after surgery. Standard post-operative topical antibiotic and steroid will be also given concurrently, dosed QID for the first week and BID for the second week (dexamethasone 0.1% and tobramycin 0.3% eye drops association). Measurements will be carried out at baseline and after one day, 3 days, 1 week and 4 weeks from cataract extraction.
Interventions
DRUGDexamethasone+Tobramycin eye drop
dexamethasone 0.1% and tobramycin 0.3% ophthalmic suspension
DRUGBromfenac eye drop
bromfenac ophthalmic solution 0.09%
Sponsors
Azienda USL Reggio Emilia - IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* cataract * pseudoexfoliation syndrome
Exclusion criteria
* history of ocular inflammation or trauma * previous intraocular surgery * corneal haze * retinal vascular disease * diabetic retinopathy * variation of the foveal profile at OCT (macular edema, epiretinal membrane) * moderate to severe age related macular degeneration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in anterior chamber inflammation measured by Laser Flare Photometry (photon counts per millisecond) | Baseline, Day 3 | Reduction of 30% of anterior chamber inflammation evaluated by Laser Flare Photometry (LFP) in the bromfenac arm when compared to the non-bromfenac arm at postoperative day 3. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with central macular thickness greater than 300 microns | Baseline, Week 4 | Macular thickness will be evaluated by Spectral Domain Optical Coherence Tomography (SD-OCT). |
| Proportion of subjects with best corrected visual acuity equal to 20/20 | Baseline, Week 1 | — |
| Proportion of patients who had no ocular pain | Baseline, Day 3 | — |
Countries
Italy
Outcome results
None listed