Diclofenac vs Dexamethasone in Combined Surgery

NCT ID: NCT00825864

Last Updated: 2009-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2008-01-31

Brief Summary

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

Detailed Description

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Conditions

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Glaucoma Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1diclofenac drops treatment

four times a day for 3 months

Group Type ACTIVE_COMPARATOR

diclofenac drops

Intervention Type DRUG

one drop 4 times a day for 3 months

2dexamethasone drops

Group Type ACTIVE_COMPARATOR

dexamethasone sodium phosphate 0.1% eye drops

Intervention Type DRUG

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

Interventions

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diclofenac drops

one drop 4 times a day for 3 months

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled for combines surgery of trabeculectomy and cataract surgery

Exclusion Criteria

* severe complicated surgery like vitreal loss, expulsive hemorrhage, endophthalmitis
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Goldschleger Eye Institute, Sheba Medcial Center

Principal Investigators

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Hani Levkovitch-Verbin

Role: PRINCIPAL_INVESTIGATOR

Tel-Aviv University, Israel

Locations

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Goldschleger Eye Institute, Sheba Medcial Center

Tel Litwinsky, , Israel

Site Status

Countries

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Israel

Other Identifiers

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SHEBA-03-3123-HLV-CTIL

Identifier Type: -

Identifier Source: org_study_id

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