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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Tobramycin/Dexamethasone

Group Type ACTIVE_COMPARATOR

Drug: Tobramycin 0.3% - Dexamethasone 0.1%

Intervention Type DRUG

one drop four times per day

Drug: Tobramycin-Dexamethasone plus Ketorolac tromethamine

Intervention Type DRUG

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

Tobramycin/Dexamethasone plus Ketorolac tromethamine

Group Type ACTIVE_COMPARATOR

Drug: Tobramycin 0.3% - Dexamethasone 0.1%

Intervention Type DRUG

one drop four times per day

Drug: Tobramycin-Dexamethasone plus Ketorolac tromethamine

Intervention Type DRUG

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

Interventions

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Drug: Tobramycin 0.3% - Dexamethasone 0.1%

one drop four times per day

Intervention Type DRUG

Drug: Tobramycin-Dexamethasone plus Ketorolac tromethamine

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

Intervention Type DRUG

Other Intervention Names

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Tobradex Acular

Eligibility Criteria

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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

Minimum Eligible Age

55 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No