Comparative Study 27G Vitrectomy vs Larger Gauge Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- changes in post-operative outcome of pain
Study Overview
Brief Summary
Two-arm, mono-center, prospective, interventional comparative case study to compare postoperative recovery between the 27G and larger gauge surgical approach.
Detailed Description
A prospective randomized comparison of postoperative recovery between 27-gauge and larger gauge surgical approaches to evaluate efficiencies and postoperative outcomes of the surgical gauges. Fifty patients who were scheduled to undergo pars plana vitrectomy (PPV) for floaters or macular surgery were treated with either 27-gauge or 23-gauge techniques and assessed for efficiency of the procedures as well as a variety of postop indicators of pain and inflammation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients aged over 18
- •No prior vitrectomy surgery in the study eye (for the same eye)
- •No prior inclusion in this trial
- •Scheduled for vitrectomy for floater removal or macular surgery (including macular holes) without endotamponades such as PFCL, Gas, Silicone oil). (Air tamponade is allowed )
Exclusion Criteria
- •• Patients with serious heart, lung, liver, or kidney dysfunction
- •Patients with proliferative diabetic retinopathy, endophthalmitis, uveitis, eyes with refraction >+5D or exceeding -8D , or other eye disease that impacts the outcome of vitrectomy surgery
- •Patients with HIV
- •Patients with history of drug abuse or alcoholism
- •Patients participating in other drug or medical device clinical trials before screening for this trial
Outcomes
Primary Outcomes
changes in post-operative outcome of pain
Time Frame: day 1 postoperative
by assessing the amount of pain on a visual analogue scale (score 0-9)
changes in post-operative outcome of redness
Time Frame: day 1 postoperative
scoring the amount of redness on a scale 0-4 through eye photos
changes in post-operative outcome in grading of anterior chamber cells
Time Frame: day 1 postoperative
clinical assessment by slit lamp examination (Tyndall 0-3 and Cells 0-3)
Secondary Outcomes
- visual acuity(day 1 postoperative)
- pain-assessment(1 week postoperative)
- intra-ocular pressure(day 1 postoperative)