search
Back to results

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

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Tobramycin 0.3% - Dexamethasone 0.1%
Tobramycin 0.3% - Dexamethasone 0.1% plus Ketorolac tromethamine 0.5%
Sponsored by
Veroia General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring Cataract, Phacoemulsification, Treatment duration

Eligibility Criteria

55 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Ophthalmology, Veroia General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Tobramycin 0.3% - Dexamethasone 0.1%

Tobramycin-Dexamethasone plus Ketorolac tromethamine

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 8, 2009
Last Updated
October 8, 2009
Sponsor
Veroia General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT00992355
Brief Title
Tobramycin-Dexamethasone Versus Tobramycin-Dexamethasone Plus Ketorolac After Phacoemulsification Surgery
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Veroia General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Cataract, Phacoemulsification, Treatment duration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tobramycin 0.3% - Dexamethasone 0.1%
Arm Type
Active Comparator
Arm Title
Tobramycin-Dexamethasone plus Ketorolac tromethamine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Tobramycin 0.3% - Dexamethasone 0.1%
Intervention Type
Drug
Intervention Name(s)
Tobramycin 0.3% - Dexamethasone 0.1% plus Ketorolac tromethamine 0.5%

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Ophthalmology, Veroia General Hospital
City
Veroia
ZIP/Postal Code
59100
Country
Greece

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs