Back to resultsDiclofenac vs Dexamethasone in Combined Surgery
Primary Purpose
Glaucoma, Cataract
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
diclofenac drops
dexamethasone sodium phosphate 0.1% eye drops
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma
Eligibility Criteria
Inclusion Criteria:
- Patients scheduled for combines surgery of trabeculectomy and cataract surgery
Exclusion Criteria:
- severe complicated surgery like vitreal loss, expulsive hemorrhage, endophthalmitis
Sites / Locations
- Goldschleger Eye Institute, Sheba Medcial Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1diclofenac drops treatment
2dexamethasone drops
Arm Description
four times a day for 3 months
Outcomes
Primary Outcome Measures
intraocular pressure
Secondary Outcome Measures
the number of antiglaucoma medications
Full Information
NCT ID
NCT00825864
First Posted
January 18, 2009
Last Updated
January 18, 2009
Sponsor
Sheba Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00825864
Brief Title
Diclofenac vs Dexamethasone in Combined Surgery
Official Title
Evaluation the Effect of Diclofenac Drops vs Dexamethasone Drops in Trabeculectomy and Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sheba Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To study the effect of Diclofenac drops or Dexamethasone drops on combined surgery of trabeculectomy and cataract surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1diclofenac drops treatment
Arm Type
Active Comparator
Arm Description
four times a day for 3 months
Arm Title
2dexamethasone drops
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
diclofenac drops
Intervention Description
one drop 4 times a day for 3 months
Intervention Type
Drug
Intervention Name(s)
dexamethasone sodium phosphate 0.1% eye drops
Intervention Description
for first week after the operation : one drop 6 times a day. Then tapering by reducing one drop for a week
Primary Outcome Measure Information:
Title
intraocular pressure
Time Frame
year
Secondary Outcome Measure Information:
Title
the number of antiglaucoma medications
Time Frame
year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients scheduled for combines surgery of trabeculectomy and cataract surgery
Exclusion Criteria:
severe complicated surgery like vitreal loss, expulsive hemorrhage, endophthalmitis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hani Levkovitch-Verbin
Organizational Affiliation
Tel-Aviv University, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Goldschleger Eye Institute, Sheba Medcial Center
City
Tel-Hashomer
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Diclofenac vs Dexamethasone in Combined Surgery
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