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Completed

NCT Number: NCT01103401

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

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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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

55 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Drug: Tobramycin 0.3% - Dexamethasone 0.1%

Drug

one drop four times per day

Other names: Tobradex

Drug: Tobramycin-Dexamethasone plus Ketorolac tromethamine

Drug

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

Other names: Acular

Primary outcomes

  1. Visual acuity, corneal edema, Tyndall reaction, redness

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

Sponsors and collaborators

Lead sponsor

Veroia General Hospital

Other

Registry information

Official study title

Ketorolac Plus Tobramycin/Dexamethasone vs. Tobramycin/Dexamethasone After Uneventful Phacoemulsification Surgery

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 14, 2010
Registry last updated
Apr 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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