Diclofenac vs Dexamethasone in Combined Surgery

Cataract Clinical Trial

Official title:

Evaluation the Effect of Diclofenac Drops vs Dexamethasone Drops in Trabeculectomy and Cataract Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00825864
• Other study ID #: SHEBA-03-3123-HLV-CTIL
• Status: Completed
• Phase: N/A
• First received: January 18, 2009
• Last updated: January 18, 2009
• Start date: January 2004
• Est. completion date: January 2008

Study information

• Verified date: January 2009
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Patients scheduled for combines surgery of trabeculectomy and cataract surgery

Exclusion Criteria:

• severe complicated surgery like vitreal loss, expulsive hemorrhage, endophthalmitis

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Glaucoma

Intervention

Drug:
• diclofenac drops
one drop 4 times a day for 3 months
• 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

Locations

Country	Name	City	State
Israel	Goldschleger Eye Institute, Sheba Medcial Center	Tel-Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intraocular pressure		year	No
Secondary	the number of antiglaucoma medications		year	No