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

Veroia General Hospital

Status: Completed

Conditions: Cataract

Treatments: Drug: Tobramycin 0.3% - Dexamethasone 0.1%; Drug: Tobramycin 0.3% - Dexamethasone 0.1% plus Ketorolac tromethamine 0.5%

Study type: Interventional

Funder types: Other

Identifiers

NCT00992355

VGH-EYE01

Details and patient eligibility

About

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.

Enrollment: 97 patients

Sex: All

Ages: 55 to 95 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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97 participants in 2 patient groups

Tobramycin 0.3% - Dexamethasone 0.1%

Active Comparator group

Treatment:

Drug: Tobramycin 0.3% - Dexamethasone 0.1%

Tobramycin-Dexamethasone plus Ketorolac tromethamine

Active Comparator group

Treatment:

Drug: Tobramycin 0.3% - Dexamethasone 0.1% plus Ketorolac tromethamine 0.5%