Randamized clinical trial of pars plana vitrectomy for macular edema from branch retinal vein occlusion

UMIN ID: C000000433

Registered date:30/06/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Patients with macular edema from branch retinal vein occlusion
• Date of first enrollment: 2006/04/01
• Target sample size: 160
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Group1: grid laser photocoagulation
Group2: pars plana vitrectomy

Outcome(s)

• Primary Outcome: 12 months distant visual acuity 12 months foveal retinal thickness
• Secondary Outcome: Course of distant visual acuity over treatment period Course of foveal retinal thickness over treatment period Ischemic maculopathy at 12 months

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: Ischemic maculopathy and macular degeneration Presence of hemorrhage directly in the fovea Additional ocular disease reducing the visual acuity Sitting systolic blood pressure greater than 180 mmHg or diastolic blood pressure greater than 110 mmHg at the screening visit History of systemic corticosteroids within 4 months prior to randomization History of laser photocoaguration for macular edema History of major ocular surgery within 6 months prior to randomization History of peribulbar or retrobulbar or intravitreal corticosteroid use History of pars plana vitrectomy Aphakia Pregnancy History of allergy to fluorescein uncontrollable systemic disease participation in another trial

Related Information

• Primary Sponsor: Kagoshima University Graduate School of Medical and Dental Sciences
• Source(s) of Monetary Support: None