NCT00825864

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 18, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 21, 2009

Completed
Last Updated

January 21, 2009

Status Verified

January 1, 2009

Enrollment Period

4 years

First QC Date

January 18, 2009

Last Update Submit

January 18, 2009

Conditions

GlaucomaCataract

Outcome Measures

Primary Outcomes (1)

  • intraocular pressure

    year

Secondary Outcomes (1)

  • the number of antiglaucoma medications

    year

Study Arms (2)

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

diclofenac dropsDRUG

one drop 4 times a day for 3 months

1diclofenac drops treatment
dexamethasone sodium phosphate 0.1% eye dropsDRUG

for first week after the operation : one drop 6 times a day. Then tapering by reducing one drop for a week

2dexamethasone drops

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for combines surgery of trabeculectomy and cataract surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Goldschleger Eye Institute, Sheba Medcial Center

Tel Litwinsky, Israel

Location

MeSH Terms

Conditions

GlaucomaCataract

Interventions

dexamethasone 21-phosphateOphthalmic Solutions

Condition Hierarchy (Ancestors)

Ocular HypertensionEye DiseasesLens Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Study Officials

  • Hani Levkovitch-Verbin

    Tel-Aviv University, Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

January 18, 2009

First Posted

January 21, 2009

Study Start

January 1, 2004

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

January 21, 2009

Record last verified: 2009-01

Locations

IL(1)