CLINICAL OUTCOMES OF BEVELED TIP, ULTRA-HIGH SPEED, 25-GAUGE PARS PLANA VITRECTOMY SYSTEM
Phase 4
- Conditions
- Vitreo-retinal diseases treatable by surgery
- Registration Number
- JPRN-UMIN000044421
- Lead Sponsor
- Peregrine Eye and Laser Institute
- Brief Summary
The surgical objectives were achieved in all 50 eyes. The mean total operative time, core, shave and total vitrectomy times were 1891, 204, 330, 534 seconds, respectively. The mean number of surgical steps was 4.3. The mean number of times an ancillary instrument was placed inside the eye was 4.5. The mean CDVA at the three-month postoperative visit improved by 0.53 logMAR units (P=0.001).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ability of a 25-gauge, 10,000 CPM, bevel tip cutter probe to complete the surgical objectives for eyes undergoing PPV
- Secondary Outcome Measures
Name Time Method 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)