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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01103401
• Other study ID #: VGH-EYE02
• Status: Completed
• Phase: N/A
• First received: April 13, 2010
• Last updated: April 14, 2015
• Start date: October 2009
• Est. completion date: January 2010

Study information

• Verified date: April 2010
• Source: Veroia General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 95 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

Drug:
• Drug: Tobramycin 0.3% - Dexamethasone 0.1%
one drop four times per day
• Drug: Tobramycin-Dexamethasone plus Ketorolac tromethamine
Tobramycin-Dexamethasone one drop four times per day and Ketorolac tromethamine one drop three times per day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Veroia General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity, corneal edema, Tyndall reaction, redness		1,7,14,28 post-operative day, Up to 28 days	Yes