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Ketorolac Plus Tobramycin/Dexamethasone Versus Tobramycin/Dexamethasone After Uneventful Phacoemulsification Surgery

Ketorolac Plus Tobramycin/Dexamethasone vs. Tobramycin/Dexamethasone After Uneventful Phacoemulsification Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01103401
Enrollment
145
Registered
2010-04-14
Start date
2009-10-31
Completion date
2010-01-31
Last updated
2015-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Brief summary

This randomized controlled trial compares two regimens of topical therapy: * tobramycin 0.3% - dexamethasone 0.1% (TobraDex®, Alcon), one drop four times/day * combination of tobramycin 0.3% - dexamethasone 0.1% (TobraDex®, Alcon), one drop four times/day, plus Ketorolac tromethamine 0.5% (Acular®, Allergan), one drop three times/day. Patients are independently assessed by two ophthalmologists. On days 7,14,21,28 patients are evaluated for * corneal edema * conjunctival hyperemia * anterior chamber (Tyndall) reaction. The investigators purpose was to evaluate the benefit of adding a non-steroid agent to an antibiotic/steroid combination after uneventful phacoemulsification. Adopting a weekly follow-up, to gain insight into the optimal duration of postoperative treatment and to examine whether risk factors for inflammation exist.

Detailed description

Patients were randomized to: i) tobramycin 0.3% - dexamethasone 0.1% one drop qid (TD group, n=72, 28 days) and ii) combination of tobramycin 0.3% - dexamethasone 0.1%, one drop qid, plus Ketorolac tromethamine 0.5%, one drop tid (TD-K group, n=73, 28 days). Patients undergoing vitrectomy due to posterior capsule rupture were excluded. On days 7, 14, 21, 28, the frequency of inflammation-related signs \[corneal edema, conjunctival hyperemia, anterior chamber (Tyndall) reaction\], as well as the best corrected visual acuity (BCVA) were measured. On day 21, logistic regression was performed to evaluate risk factors for inflammation.

Interventions

DRUGDrug: Tobramycin 0.3% - Dexamethasone 0.1%

one drop four times per day

DRUGDrug: Tobramycin-Dexamethasone plus Ketorolac tromethamine

Tobramycin-Dexamethasone one drop four times per day and Ketorolac tromethamine one drop three times per day

Sponsors

Veroia General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
55 Years to 95 Years
Healthy volunteers
No

Inclusion criteria

* phacoemulsification (due to cataract) * uneventful phacoemulsification surgery

Exclusion criteria

* history of intraocular surgery in the operated eye, * any previous episode of uveitis in the operated eye, * severe systemic disease (heart failure NYHA stage III of IV, end-stage renal failure, pulmonary failure, patients receiving chemotherapy), * regular, systemic use of steroid or non-steroid anti-inflammatory drugs during the last three months * disruption of the anterior lens capsule

Design outcomes

Primary

MeasureTime frame
Visual acuity, corneal edema, Tyndall reaction, redness1,7,14,28 post-operative day, Up to 28 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026