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Investigator-initiated, comparative double-arm, mono-center, prospective, interventional case study to determine whether ultra-small gauge surgery (27G gauge needle) improves postoperative outcome and patient morbidity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 23G gauge needle vitrectomy surgery | Experimental |
| |
| 27G gauge needle vitrectomy surgery | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitrectomy (23G gauge needle) | Device | Vitrectomy surgery with 23G gauge needle technique |
|
| 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) | 1 week |
| Changes in post-operative outcome of redness | Scoring the amount of redness on a scale 0-4 through eye photos | 1 week |
| Changes in post-operative outcome of measured inflammation | Measuring the amount of inflammation by measurement of Flare (photon/ms) | 1 week |
| Changes in post-operative outcome in grading of anterior chamber cells | Clinical assesment by slit lamp (Tyndall 0 - 3 and Cells 0 - 3) | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative parameter: Visual acuity | Best corrected visual acuity in LogMar will be obtained to report the visual acuity. | 1 week |
| Post-operative parameter: Intraocular pressure | Millimeter of Mercury pressure (mmHG) will be measured to report the intraocular pressure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Stalmans, MD Phd | UZ Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Leuven (UZ Leuven) | Leuven | Vl-Brabant | 3000 | Belgium |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 17, 2022 | |
| Reset | Jul 13, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 17, 2022 | Jul 13, 2023 |
| ID | Term |
|---|---|
| D014821 | Vitrectomy |
| ID | Term |
|---|---|
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Vitrectomy (27G gauge needle) | Device | Vitrectomy surgery with 27G gauge needle technique |
|
| 1 week |
| Post-operative parameter: 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 |