CompletedPhase 4

Bromfenac Versus Dexamethasone After Cataract Surgery

Italy92 participantsStarted 2017-10-16

Plain-language summary

The aim of the study is to compare bromfenac to dexamethasone eye drops to control inflammation after cataract surgery. Inflammation in the anterior chamber of the eye will be measured by a Laser Flare Photometer (LFP).

Who can participate

Age range60 Years – 90 Years

SexALL

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Inclusion criteria

✓. Age \> 60 year old.
✓. Uneventful cataract surgery. Surgical procedure, as described in the patients chart, should be free of any form of intraoperative complication that may increase postoperative inflammation.
✓. Availability of relevant ocular history, including: Best Corrected Visual Acuity testing, Laser Flare Photometry, Optical Coherence Tomography, slit lamp biomicroscopy, intraocular pressure (with pneumotonometer), dilated fundus ophthalmoscopy.
✓. Ability and willing to follow all instructions and attend all study visits
✓. Ability to self-administer study drug (or have a caregiver available to instill all doses of study drug)
✓. Ability and willing to provide informed consent for this study protocol.
✓. No ocular, topical, systemic, or inhaled NSAIDs or ocular, topical, or systemic gentamicin, or cyclosporine ophthalmic emulsion within 1 week of investigational product initiation or throughout the duration of the study;
✓. No topical, inhaled, or systemic corticosteroids within 15 days or depot corticosteroids within 45 days of the investigational product initiation or or throughout the duration of the study;

Exclusion criteria

✕. Ocular exclusion criteria:
✕. history of ocular inflammation or trauma;
✕. history of previous intraocular surgery;
✕. corneal haze, edema or any condition that can interfere with LFP measurement by means of reduced transparency of the cornea;
✕. preoperative LFP value \> 12 ph/ms (as per patient' chart)
✕. pseudoexfoliation lentis;
✕. retinal vascular diseases;
✕. diabetic retinopathy;

What they're measuring

Flare to baseline

Timeframe: Within one month

Flare at day 14

Timeframe: 14 days

Trial details

NCT IDNCT03317847

SponsorAzienda USL Reggio Emilia - IRCCS

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2018-06-14

View on ClinicalTrials.gov More Inflammation Eye trials