Diclofenac vs Dexamethasone in Combined Surgery | NCT00825864

Studies
Diclofenac vs Dexamethasone in Combined Surgery

NCT00825864

Sponsor

Sheba Medical Center

Status

Completed

Last Update Posted

Jan 21, 2009Estimated

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Glaucoma
Cataract

Interventions

diclofenac drops
dexamethasone sodium phosphate 0.1% eye drops

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2004

Primary Completion Date

Jan 2008Actual

Completion Date

Jan 2008Actual

First Submitted Date

Jan 18, 2009

First Submission Date that Met QC Criteria

Jan 18, 2009

First Posted Date

Jan 21, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 18, 2009

Last Update Posted Date

Jan 21, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1diclofenac drops treatment	Active Comparator	four times a day for 3 months	Drug: diclofenac drops
2dexamethasone drops	Active Comparator		Drug: dexamethasone sodium phosphate 0.1% eye drops

Interventions

Name	Type	Description	Arm Group Labels	Other Names
diclofenac drops	Drug	one drop 4 times a day for 3 months	1diclofenac drops treatment

Measure	Description	Time Frame
intraocular pressure		year

Measure	Description	Time Frame
the number of antiglaucoma medications		year

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hani Levkovitch-Verbin	Tel Aviv University, Israel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Goldschleger Eye Institute, Sheba Medcial Center		Tel Litwinsky			Israel

Condition Browse Module

MeSH Terms

ID	Term
D005901	Glaucoma
D002386	Cataract

Ancestor Terms

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases
D007905	Lens Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C004180	dexamethasone 21-phosphate
D009883	Ophthalmic Solutions

Ancestor Terms

ID	Term
D019999	Pharmaceutical Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations
D045506	Therapeutic Uses

Browse Leaves

Not provided

Browse Branches

Not provided