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OpenTrials
Completed

NCT Number: NCT00370409

Cryotherapy of Sclerotomy Sites for Prevention of Late Postvitrectomy Diabetic Hemorrhage

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.

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Key information

Conditions

Late Postvitrectomy Diabetic Hemorrhage.

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ophthalmic Research Center

Tehran, Tehran Province, 16666, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cryotherapy

Procedure

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

Primary outcomes

  1. Prevention of late vitreous hemorrhage in postvitrectomized diabetic eyes

    Time frame: 6 months

Secondary outcomes

  1. Incidence of late vitreous hemorrhage in the cryo group.

    Time frame: 6 months

  2. Incidence of late vitreous hemorrhage in the control group.

    Time frame: 6 months

  3. Comparing incidence of late vitreous hemorrhage in both groups.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University of Medical Sciences

Other

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Aug 31, 2006
Registry last updated
Aug 1, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.