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

NCT ID: NCT00992355

Last Updated: 2009-10-09

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

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-04-30

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. 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.

Detailed Description

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Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tobramycin 0.3% - Dexamethasone 0.1%

Group Type ACTIVE_COMPARATOR

Tobramycin 0.3% - Dexamethasone 0.1%

Intervention Type DRUG

Tobramycin-Dexamethasone plus Ketorolac tromethamine

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

Interventions

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Tobramycin 0.3% - Dexamethasone 0.1%

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Veroia General Hospital

OTHER

Sponsor Role lead

Locations

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Department of Ophthalmology, Veroia General Hospital

Véroia, , Greece

Site Status

Countries

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Greece

Other Identifiers

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VGH-EYE01

Identifier Type: -

Identifier Source: org_study_id

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