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OpenTrials
Completed

NCT Number: NCT00992355

Tobramycin-Dexamethasone Versus Tobramycin-Dexamethasone Plus Ketorolac After 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. 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.

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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

Primary location

Department of Ophthalmology, Veroia General Hospital

Véroia, 59100, Greece

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

  • Disruption of the anterior lens capsule
  • Age-related macular degeneration
  • Proliferative diabetic retinopathy
  • Glaucoma

Treatment and study plan

Tobramycin 0.3% - Dexamethasone 0.1%

Drug

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

Drug

Sponsors and collaborators

Lead sponsor

Veroia General Hospital

Other

Registry information

Official study title

Tobramycin 0.3% - Dexamethasone 0.1% Versus Tobramycin 0.3% - Dexamethasone 0.1% Plus Ketorolac Tromethamine 0.5% After Phacoemulsification Surgery. A Randomized Trial

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Oct 9, 2009
Registry last updated
Oct 9, 2009

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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