Intravitreal Long Acting Gas in the Prevention of Early Postoperative Vitreous Hemorrhage in Diabetic Vitrectomy

NCT00155454 | Completed DMC

• 1 other identifier: 9461700621
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

Recurrent vitreous hemorrhage after vitrectomy for complications of diabetic retinopathy is a common occurrence. The hemorrhage may appear within the first few weeks after surgery or months later. This complication may delay visual rehabilitation significantly and sometimes requires additional procedures or surgery, jeopardizing previous successful operation. The causes of bleeding are diverse. While evidence suggests fibrovascular proliferation from the sclerotomy sites or in the vitreous base may be an important source of recurrent vitreous hemorrhage, other origins of hemorrhage exist including lysed clot from residual vitreous skirt, injured retinal vessels from surgery, and incompletely removed fibrovascular tissues. The latter three conditions may be the major sources of early postoperative vitreous hemorrhage. We have shown that peripheral retinal cryotherapy along with cryo treatment at the sclerotomy sites may effectively reduce the incidence of fibrovascular proliferation at the inner surface of sclerotomy sites and prevent the late-onset recurrent vitreous hemorrhage. However, many patients still experience disturbing vitreous hemorrhage within the first two to three weeks after post-operative transient clear-up of the vitreous. We hypothesize that gas bubble within the vitreous cavity may mechanically temponade the fragile retinal vessels, and concentrate the coagulation factors in the vitreous cavity, allowing the integrity of vessel walls gradually recovers and thus preventing the occurrence of early postoperative recurrent vitreous hemorrhage. To test this hypothesis, a clinical study was undertaken to investigate the effect of long-acting gas infused into the vitreous cavity at the end of diabetic vitrectomy in the prevention of recurrent vitreous hemorrhage.

Conditions

Diabetes Mellitus; Diabetic Retinopathy; Vitreous Hemorrhage

Keywords

Diabetic retinopathy; Vitrectomy; Postoperative vitreous hemorrahge; Intravitreal gas injection

Outcome Measures

Primary Outcomes (1)

• Recurrent vitreous hemorrhage rate

  Initial time to vitreous clearing , percentage of prolonged vitreous clearing, and early versus late manifest postoperative recurrent vitreous hemorrhage in groups 1 and 2 were compared to determine the effects of long acting gas on prevention of early recurrent vitreous hemorrhage.

  Within 6 months after vitrectomy

Study Arms (2)

Study group

EXPERIMENTAL

Group 1 had intravitreal long acting gas (10% C3F8) injection in the vitreous cavity at the end of surgery

Procedure: Intravitreal long acting gas (10% C3F8)

Control group

SHAM COMPARATOR

Group 2 did not receive intravitreal long acting gas (10% C3F8)

Procedure: Intravitreal long acting gas (10% C3F8)

Interventions

Intravitreal long acting gas (10% C3F8) PROCEDURE

At the end of surgery, fluid-gas exchange with 10% C3F8 were done in the eye of study group

Control group; Study group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing primary pars plana vitrectomy for complications of proliferative diabetic retinopathy were recruited for the prospective study

You may not qualify if:

• (1) anticoagulant therapy had been used prior to surgery or during post-operative follow-up period; (2) positive medical history of blood diseases associated with abnormal blood coagulation.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Retinopathy; Vitreous Hemorrhage

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Eye Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chung-May Yang, MD

  National Taiwan University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: September 1, 2004
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 27, 2012

Record last verified: 2012-12

Locations

TW (1)