Vitreoretinal Surgery
Conditions
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.
Interventions
DEVICEvitrectomy (27G gauge or larger needle)
vitrectomy surgery for either floater removal or macular surgery, with or without combined cataract (phaco) surgery.
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes in post-operative outcome of pain | day 1 postoperative | by assessing the amount of pain on a visual analogue scale (score 0-9) |
| changes in post-operative outcome of redness | 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 | day 1 postoperative | clinical assessment by slit lamp examination (Tyndall 0-3 and Cells 0-3) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| visual acuity | day 1 postoperative | best corrected visual acuity in LogMar will be obtained to report the visual acuity |
| intra-ocular pressure | day 1 postoperative | Millimeter of Mercury pressure (mmHg) will be measured to report the intra-ocular pressure |
| pain-assessment | 1 week postoperative | a questionnaire with visual analogue scale will be used to assess the level of pain up to 1 week after the operation |
Countries
Belgium
Outcome results
None listed