Diclofenac vs Dexamethasone in Combined Surgery

This study has been completed.

Sponsor:

Information provided by:

Sheba Medical Center

ClinicalTrials.gov Identifier:

NCT00825864

First received: January 18, 2009

Last updated: NA

Last verified: January 2009

History: No changes posted

Tracking Information

First Received Date ^ICMJE

January 18, 2009

Last Updated Date

January 18, 2009

Start Date ^ICMJE

January 2004

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

intraocular pressure [ Time Frame: year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

the number of antiglaucoma medications [ Time Frame: year ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Diclofenac vs Dexamethasone in Combined Surgery

Official Title ^ICMJE

Evaluation the Effect of Diclofenac Drops vs Dexamethasone Drops in Trabeculectomy and Cataract Surgery

Brief Summary

To study the effect of Diclofenac drops or Dexamethasone drops on combined surgery of trabeculectomy and cataract surgery.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Glaucoma
Cataract

Intervention ^ICMJE

Drug: diclofenac drops
one drop 4 times a day for 3 months
Drug: dexamethasone sodium phosphate 0.1% eye drops
for first week after the operation : one drop 6 times a day. Then tapering by reducing one drop for a week

Study Arm (s)

Active Comparator: 1diclofenac drops treatment
four times a day for 3 months

Intervention: Drug: diclofenac drops
Active Comparator: 2dexamethasone drops
Intervention: Drug: dexamethasone sodium phosphate 0.1% eye drops

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

January 2008

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients scheduled for combines surgery of trabeculectomy and cataract surgery

Exclusion Criteria:

severe complicated surgery like vitreal loss, expulsive hemorrhage, endophthalmitis

Gender

Both

Ages

40 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Israel

Administrative Information

NCT Number ^ICMJE

NCT00825864

Other Study ID Numbers ^ICMJE

SHEBA-03-3123-HLV-CTIL

Has Data Monitoring Committee

Responsible Party

Levkovitch-Verbin Hani, Goldschleger Eye Institute, Sheba Medcial Center

Study Sponsor ^ICMJE

Sheba Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Hani Levkovitch-Verbin

Tel-Aviv University, Israel

Information Provided By

Sheba Medical Center

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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