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To evaluate the intra-operative efficacy of a new intra-operative viewing device.
This study is designed to obtain more information on the efficacy of the disposable RESIGHT lenses in routine vitrectomy surgery. This information can lead to adjustments to these surgical lenses to further fine tune a device which can be used by other surgeons.
Theoretically, both the improved lens design and better resistance to fogging should improve the visualization of the retina hence facilitate the surgery, increasing the surgical safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group 1 | Active Comparator | primary vitrectomy surgery for retinal detachment |
|
| group 2 | Active Comparator | macular surgery: pucker, vitreomacular traction or macular hole |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZEISS disposable | Device | a comparison will be done between the present lenses used (reusable RESIGHT lenses and disposable Vitreq contact lens) and the new disposable RESIGHT lenses. |
| Measure | Description | Time Frame |
|---|---|---|
| Ultra Wide Field lens View Angle evaluation | Ultra Wide Field lens View Angle: scale from 1 (far more indentation) to 5 (far less indentation) | during surgery |
| Ultra Wide Field lens Condensation evaluation | Ultra Wide Field lens Condensation: scale from 1 (far more condensation) to 5 (far less condensation) | during surgery |
| Wide Angle lens Condensation evaluation | Wide Angle lens Condensation: scale from 1 (far more condensation ) to 5 (far less condensation) | during surgery |
| Illumination appearance evaluation | Illumination intensity required during the surgery : scale from 1 (significantly higher) to 5 (significantly lower) | during surgery |
| Color appearance evaluation | color appearance during the surgery : scale from 1 (far less natural colors) to 5 (far better natural colors ) | during surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Stalmans, PhD, MD | UZ Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitaire Ziekenhuizen Leuven | Leuven | Vlaams-Brabant | 3000 | Belgium |
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| 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 | Mar 7, 2023 | May 4, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012163 | Retinal Detachment |
| D019773 | Epiretinal Membrane |
| D012167 | Retinal Perforations |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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