Diclofenac vs Dexamethasone in Combined Surgery

January 18, 2009 updated by: Sheba Medical Center

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel-Hashomer, Israel
        • Goldschleger Eye Institute, Sheba Medcial Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients scheduled for combines surgery of trabeculectomy and cataract surgery

Exclusion Criteria:

  • severe complicated surgery like vitreal loss, expulsive hemorrhage, endophthalmitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1diclofenac drops treatment
four times a day for 3 months
Drug: diclofenac drops
one drop 4 times a day for 3 months
ACTIVE_COMPARATOR: 2dexamethasone drops
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
intraocular pressure
Time Frame: year
year

Secondary Outcome Measures

Outcome Measure
Time Frame
the number of antiglaucoma medications
Time Frame: year
year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Investigators

  • Principal Investigator: Hani Levkovitch-Verbin, Tel-Aviv University, Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (ACTUAL)

January 1, 2008

Study Completion (ACTUAL)

January 1, 2008

Study Registration Dates

First Submitted

January 18, 2009

First Submitted That Met QC Criteria

January 18, 2009

First Posted (ESTIMATE)

January 21, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

January 21, 2009

Last Update Submitted That Met QC Criteria

January 18, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-03-3123-HLV-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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