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Cryotherapy of Sclerotomy Sites for Prevention of Late Postvitrectomy Diabetic Hemorrhage

NCT ID: NCT00370409

Last Updated: 2008-08-01

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

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-06-30

Brief Summary

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Late vitreous hemorrhage in postvitrectomized diabetic eyes may be due to fibrovascular tuft formation in sclerotomy sites. Cryotherapy of sclerotomy sites may prevent bleeding by regressing the fibrovascular tuft. This study will detect the safety and efficacy of cryotherapy of sclerotomy sites for prevention of late vitreous hemorrhage in vitrectomized diabetic eyes.

Detailed Description

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Conditions

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Late Postvitrectomy Diabetic Hemorrhage.

Keywords

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Rebleeding Diabetic vitreous hemorrhage Cryotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1

Cryotherapy

Group Type EXPERIMENTAL

Cryotherapy

Intervention Type PROCEDURE

Cryotherapy of both sides of sclerotomy sites was done for 6 seconds after complition of operation.

2

Group Type PLACEBO_COMPARATOR

Cryotherapy

Intervention Type PROCEDURE

Cryotherapy of both sides of sclerotomy sites was done for 6 seconds after complition of operation.

Interventions

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Cryotherapy

Cryotherapy of both sides of sclerotomy sites was done for 6 seconds after complition of operation.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Diabetic retinopathy cases undergoing vitrectomy

Exclusion Criteria

* History of deep vitrectomy or cataract surgery
* Renal failure
* Silicone oil injection during surgery
* Early rebleeding
* History of antithrombotic drugs usage
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Principal Investigators

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Morteza Entezari, MD

Role: PRINCIPAL_INVESTIGATOR

Ophthalmic Research Center of Shaheed Beheshti Medical University

Locations

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Ophthalmic Research Center

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

Other Identifiers

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8525

Identifier Type: -

Identifier Source: org_study_id