Macular Holes, Macular Pucker, Retinal Detachment, Vitreomacular Traction
Conditions
Brief summary
To evaluate the intra-operative efficacy of a new intra-operative viewing device.
Detailed description
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.
Interventions
DEVICEZEISS disposable
a comparison will be done between the present lenses used (reusable RESIGHT lenses and disposable Vitreq contact lens) and the new disposable RESIGHT lenses.
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures * Patients that are scheduled for primary vitrectomy surgery to treat retinal detachment or macular disease (pucker, macular hole, vitreomacular traction). * Both vitrectomy-only and combined phaco-vitrectomy surgeries * General or local anesthesia, or combination
Exclusion criteria
* Patient who do not have sufficient command of the Dutch language to read and understand the informed consent form * Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the CIP. * Repeat vitrectomy surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ultra Wide Field lens View Angle evaluation | during surgery | Ultra Wide Field lens View Angle: scale from 1 (far more indentation) to 5 (far less indentation) |
| Ultra Wide Field lens Condensation evaluation | during surgery | Ultra Wide Field lens Condensation: scale from 1 (far more condensation) to 5 (far less condensation) |
| Wide Angle lens Condensation evaluation | during surgery | Wide Angle lens Condensation: scale from 1 (far more condensation ) to 5 (far less condensation) |
| Illumination appearance evaluation | during surgery | Illumination intensity required during the surgery : scale from 1 (significantly higher) to 5 (significantly lower) |
| Color appearance evaluation | during surgery | color appearance during the surgery : scale from 1 (far less natural colors) to 5 (far better natural colors ) |
Countries
Belgium
Outcome results
None listed