CLINICAL OUTCOMES OF BEVELED TIP, ULTRA-HIGH SPEED, 25-GAUGE PARS PLANA VITRECTOMY SYSTEM

UMIN ID: UMIN000044421

Registered date:03/06/2021

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Vitreo-retinal diseases treatable by surgery
• Date of first enrollment: 2019/04/24
• Target sample size: 50
• Countries of recruitment: Asia(except Japan)
• Study type: Interventional
• Intervention(s): 25-gauge, bevel tip, 10000 cut per minute vitrectomy probe

Outcome(s)

• Primary Outcome: Ability of a 25-gauge, 10,000 CPM, bevel tip cutter probe to complete the surgical objectives for eyes undergoing PPV
• Secondary Outcome: Presence of wound leak at end of surgery Pain assessment scores Postoperative intraocular pressures Core vitrectomy duration (from start of vitrectomy to shift to peripheral shaving setting) Frequency of need for adjunctive surgical instrumentation among eyes with proliferative retinopathy or proliferative diabetic retinopathy Adverse events (eg. retinal tear, retinal detachment)

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 100years-old
• Gender: Male and Female
• Exclude criteria: Significant Corneal opacification Scleral disorders Deficient capsular stability and integrity Inability to complete a 3 month follow up visits External eye infection Severe dry eye Glaucoma or ocular hypertension Prior glaucoma surgery Prior vitrectomy

Related Information

• Primary Sponsor: Peregrine Eye and Laser Institute
• Source(s) of Monetary Support: Peregrine Eye and Laser Institute