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
  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
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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 18, 2009
Last Updated: January 18, 2009
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Glaucoma
Cataract
Ocular Hypertension
Eye Diseases
Lens Diseases
Dexamethasone acetate
Dexamethasone
Diclofenac
Dexamethasone 21-phosphate
Sodium phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
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

ClinicalTrials.gov processed this record on July 20, 2014