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Diclofenac vs Dexamethasone in Combined Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00825864
First Posted: January 21, 2009
Last Update Posted: January 21, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sheba Medical Center
  Purpose
To study the effect of Diclofenac drops or Dexamethasone drops on combined surgery of trabeculectomy and cataract surgery.

Condition Intervention
Glaucoma Cataract Drug: diclofenac drops Drug: dexamethasone sodium phosphate 0.1% eye drops

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation the Effect of Diclofenac Drops vs Dexamethasone Drops in Trabeculectomy and Cataract Surgery

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • intraocular pressure [ Time Frame: year ]

Secondary Outcome Measures:
  • the number of antiglaucoma medications [ Time Frame: year ]

Estimated Enrollment: 50
Study Start Date: January 2004
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled for combines surgery of trabeculectomy and cataract surgery

Exclusion Criteria:

  • severe complicated surgery like vitreal loss, expulsive hemorrhage, endophthalmitis
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00825864


Locations
Israel
Goldschleger Eye Institute, Sheba Medcial Center
Tel-Hashomer, Israel
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Hani Levkovitch-Verbin Tel-Aviv University, Israel
  More Information

Responsible Party: Levkovitch-Verbin Hani, Goldschleger Eye Institute, Sheba Medcial Center
ClinicalTrials.gov Identifier: NCT00825864     History of Changes
Other Study ID Numbers: SHEBA-03-3123-HLV-CTIL
First Submitted: January 18, 2009
First Posted: January 21, 2009
Last Update Posted: January 21, 2009
Last Verified: January 2009

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Dexamethasone acetate
Dexamethasone
Diclofenac
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors