Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Two-arm, mono-center, prospective, interventional comparative case study to compare postoperative recovery between the 27G and larger gauge surgical approach.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 27 gauge needle vitrectomy surgery | Active Comparator | ultra-small gauge |
|
| larger than 27 gauge (23G or 25G) needle vitrectomy surgery | Active Comparator | 23-gauge and 25-gauge instruments are a little larger in size |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vitrectomy (27G gauge or larger needle) | Device | vitrectomy surgery for either floater removal or macular surgery, with or without combined cataract (phaco) surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| changes in post-operative outcome of pain | by assessing the amount of pain on a visual analogue scale (score 0-9) | day 1 postoperative |
| changes in post-operative outcome of redness | scoring the amount of redness on a scale 0-4 through eye photos | day 1 postoperative |
| changes in post-operative outcome in grading of anterior chamber cells | clinical assessment by slit lamp examination (Tyndall 0-3 and Cells 0-3) | day 1 postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| visual acuity | best corrected visual acuity in LogMar will be obtained to report the visual acuity | day 1 postoperative |
| intra-ocular pressure | Millimeter of Mercury pressure (mmHg) will be measured to report the intra-ocular pressure |
Not provided
Inclusion Criteria:
Exclusion Criteria:
• Patients with serious heart, lung, liver, or kidney dysfunction
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Peter Stalmans, PhD | UZ Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitaire Ziekenhuizen Leuven | Leuven | 3000 | Belgium |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 20, 2020 | Jun 28, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D014821 | Vitrectomy |
| ID | Term |
|---|---|
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| day 1 postoperative |
| pain-assessment | a questionnaire with visual analogue scale will be used to assess the level of pain up to 1 week after the operation | 1 week postoperative |