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Diclofenac vs Dexamethasone in Combined Surgery

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ClinicalTrials.gov Identifier: NCT00825864
Recruitment Status : Completed
First Posted : January 21, 2009
Last Update Posted : January 21, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
To study the effect of Diclofenac drops or Dexamethasone drops on combined surgery of trabeculectomy and cataract surgery.

Condition or disease Intervention/treatment
Glaucoma Cataract Drug: diclofenac drops Drug: dexamethasone sodium phosphate 0.1% eye drops

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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
Study Start Date : January 2004
Primary Completion Date : January 2008
Study Completion Date : January 2008


Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. intraocular pressure [ Time Frame: year ]

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

Eligibility Criteria

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 Posted: January 21, 2009    Key Record Dates
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