Tobramycin-Dexamethasone Versus Tobramycin-Dexamethasone Plus Ketorolac After Phacoemulsification Surgery

Tobramycin 0.3% - Dexamethasone 0.1% Versus Tobramycin 0.3% - Dexamethasone 0.1% Plus Ketorolac Tromethamine 0.5% After Phacoemulsification Surgery. A Randomized Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00992355

Enrollment

Registered

2009-10-09

Start date

2009-01-31

Completion date

2009-04-30

Last updated

2009-10-09

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

Conditions

Cataract

Keywords

Cataract, Phacoemulsification, Treatment duration

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. The topical treatment is administered for 28 days after phacoemulsification. Patients are independently assessed by two ophthalmologists. On day 28, patients are evaluated for * corneal edema * conjunctival redness * anterior chamber reaction. Moreover, the cases necessitating continuation of treatment are compared in the two groups on day 28 and 42.

Interventions

DRUGTobramycin 0.3% - Dexamethasone 0.1%

DRUGTobramycin 0.3% - Dexamethasone 0.1% plus Ketorolac tromethamine 0.5%

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

55 Years to 95 Years

Healthy volunteers

Inclusion criteria

* Phacoemulsification (due to cataract) * Uneventful phacoemulsification surgery

Exclusion criteria

* Disruption of the anterior lens capsule * Age-related macular degeneration * Proliferative diabetic retinopathy * Glaucoma

Countries

Greece

Outcome results

None listed

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