Postoperative inflammation in patients with pseudoexfoliatio lentis undergoing cataract surgery
Conditions
Interventions
Trade Name: Yellox 0,9 mg/ml collirio
Product Name: Yellox 0.9 mg/ml collirio
Pharmaceutical Form: Eye drops
Trade Name: TOBRADEX 0,3% + 0,1% collirio sospensione
Product Name: TOBRADEX 0,3% + 0,1% c
Sponsors
Azienda Ospedaliera di Reggio Emilia Arcispedale "S.Maria Nuova"/IRCCS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main 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).;Secondary Objective: In particular, our study is intended to demonstrate: 1) a reduction in the anterior segment inflammation in PEX eyes treated with standard regimen plus bromfenac when compared to the standard treatment only. Anterior chamber inflammation will be measured with the Laser Flare Photometer. 2) a reduction in the posterior segment inflammation and incidence of macular edema in PEX eyes treated with standard regimen plus bromfenac when compared to the standard treatment only. Macular thickness will be measured with the OCT.;Primary end point(s): 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. LFP is a new, non invasive, objective method to measure ocular inflammation.;Timepoint(s) of evaluation of this end point: Third postoperative day | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Macular thickness: proportion of patients with central macular thickness greater than 300 microns at week 4. 2) Best corrected visual acuity (BCVA): proportion of subjects with BCVA equal to 10/10 at week 1. 3) Ocular discomfort: proportion of patients who had no ocular pain at day 3, evaluated by OCGA questionnaire (the Ocular Comfort Grading Assessment measures 7 ocular symptoms: eye pain, tearing, itching, foreign body sensation, photophobia, eye discharge, and haziness).;Timepoint(s) of evaluation of this end point: 1) Week 4 2) Week 1 3) Postoperative day 3 | — |
Countries
Italy
Contacts
Public ContactStruttura Complessa di Oculistica
A.O. di Reggio Emilia Arcispedale “S. Maria Nuova”/IRCCS
Outcome results
None listed