NCT00370409

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2006

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 31, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

August 1, 2008

Status Verified

July 1, 2008

Enrollment Period

2.1 years

First QC Date

August 30, 2006

Last Update Submit

July 31, 2008

Conditions

Late Postvitrectomy Diabetic Hemorrhage.

Keywords

RebleedingDiabetic vitreous hemorrhageCryotherapy

Outcome Measures

Primary Outcomes (1)

  • Prevention of late vitreous hemorrhage in postvitrectomized diabetic eyes

    6 months

Secondary Outcomes (3)

  • Incidence of late vitreous hemorrhage in the cryo group.

    6 months

  • Incidence of late vitreous hemorrhage in the control group.

    6 months

  • Comparing incidence of late vitreous hemorrhage in both groups.

    6 months

Study Arms (2)

1

EXPERIMENTAL

Cryotherapy

Procedure: Cryotherapy

2

PLACEBO COMPARATOR
Procedure: Cryotherapy

Interventions

CryotherapyPROCEDURE

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

12

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetic retinopathy cases undergoing vitrectomy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmic Research Center

Tehran, Tehran Province, 16666, Iran

Location

MeSH Terms

Interventions

Cryotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Morteza Entezari, MD

    Ophthalmic Research Center of Shaheed Beheshti Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 30, 2006

First Posted

August 31, 2006

Study Start

January 1, 2006

Primary Completion

February 1, 2008

Study Completion

June 1, 2008

Last Updated

August 1, 2008

Record last verified: 2008-07

Locations

IR(1)