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

NCT01103401 | Completed DMC

• 1 other identifier: VGH-EYE02
• Study Type: interventional
• Target: 145
• Locations: 0 countries
• Sites: N/A

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. 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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• Visual acuity, corneal edema, Tyndall reaction, redness

  1,7,14,28 post-operative day, Up to 28 days

Study Arms (2)

Tobramycin/Dexamethasone

ACTIVE COMPARATOR

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

Tobramycin/Dexamethasone plus Ketorolac tromethamine

ACTIVE COMPARATOR

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

Interventions

Drug: Tobramycin 0.3% - Dexamethasone 0.1% DRUG

one drop four times per day

Also known as: Tobradex

Tobramycin/Dexamethasone; Tobramycin/Dexamethasone plus Ketorolac tromethamine

Drug: Tobramycin-Dexamethasone plus Ketorolac tromethamine DRUG

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

Also known as: Acular

Tobramycin/Dexamethasone; Tobramycin/Dexamethasone plus Ketorolac tromethamine

Eligibility Criteria

• Age: 55 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• phacoemulsification (due to cataract)
• uneventful phacoemulsification surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Veroia General Hospital: lead

MeSH Terms

Conditions

Cataract

Interventions

Tobramycin; Tobramycin, Dexamethasone Drug Combination; Ketorolac Tromethamine

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Nebramycin; Kanamycin; Aminoglycosides; Glycosides; Carbohydrates; Dexamethasone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Drug Combinations; Pharmaceutical Preparations; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Leonidas E Papazisis, Director

  leopapazisis@yahoo.gr

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 13, 2010
• First Posted: April 14, 2010
• Study Start: October 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: April 15, 2015

Record last verified: 2010-04