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

Veroia General Hospital

Status: Completed

Conditions: Cataract

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01103401

VGH-EYE02

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.

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.

Full 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.

Enrollment: 145 patients

Sex: All

Ages: 55 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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145 participants in 2 patient groups

Tobramycin/Dexamethasone

Active Comparator group

Treatment:

Drug: Drug: Tobramycin 0.3% - Dexamethasone 0.1%

Drug: Drug: Tobramycin-Dexamethasone plus Ketorolac tromethamine

Tobramycin/Dexamethasone plus Ketorolac tromethamine

Active Comparator group

Treatment:

Drug: Drug: Tobramycin 0.3% - Dexamethasone 0.1%

Drug: Drug: Tobramycin-Dexamethasone plus Ketorolac tromethamine