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Diclofenac vs Dexamethasone in Combined Surgery

This study has been completed.
Information provided by:
Sheba Medical Center Identifier:
First received: January 18, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted

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

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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

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


Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00825864

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

No publications provided

Responsible Party: Levkovitch-Verbin Hani, Goldschleger Eye Institute, Sheba Medcial Center Identifier: NCT00825864     History of Changes
Other Study ID Numbers: SHEBA-03-3123-HLV-CTIL
Study First Received: January 18, 2009
Last Updated: January 18, 2009
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Eye Diseases
Lens Diseases
BB 1101
Dexamethasone 21-phosphate
Dexamethasone acetate
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antirheumatic Agents
Autonomic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Sensory System Agents processed this record on November 25, 2014