Evaluation of the anti-inflammatory effect of bromfenac eye drops after cataractsurgery in patients with pseudoexfoliatio of the lens
- Conditions
- Postoperative inflammation in patients with pseudoexfoliatio lentis undergoing cataractsurgeryTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2013-002066-39-IT
- Lead Sponsor
- Azienda Ospedaliera di Reggio Emilia Arcispedale S.Maria Nuova/IRCCS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Patients with cataract:
- with nuclear sclerosis of the crystalline lens graded 1 or more according to the LOCS
II classification (Lens opacities classification system II; Chylack LT et al. 1989);
- with classics sign of pseudoesfoliatio lentis (PEX).
The diagnosis of PEX will be made by demonstrating the pathognomonic white deposits
in the lens, cornea, iris and anterior hyaloid face by slit lamp examination.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 52
Patients with history of ocular inflammation or trauma, previous intraocular surgery,
corneal haze, retinal vascular disease, diabetic retinopathy, variation of the foveal
profile at OCT (including macular edema and epiretinal membrane), moderate to
severe age related macular degeneration or age < 60 year will be excluded. Only one
eye per patient will be included in our study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method