Zeiss RESIGHT Disposable Lenses Evaluation Study: Investigator-initiated, Mono-center, Academic, Prospective, Interventional Case Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Ultra Wide Field lens View Angle evaluation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
group 1
primary vitrectomy surgery for retinal detachment
Intervention: ZEISS disposable (Device)
group 2
macular surgery: pucker, vitreomacular traction or macular hole
Intervention: ZEISS disposable (Device)
Outcomes
Primary Outcomes
Ultra Wide Field lens View Angle evaluation
Time Frame: 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
Time Frame: during surgery
Ultra Wide Field lens Condensation: scale from 1 (far more condensation) to 5 (far less condensation)
Wide Angle lens Condensation evaluation
Time Frame: during surgery
Wide Angle lens Condensation: scale from 1 (far more condensation ) to 5 (far less condensation)
Illumination appearance evaluation
Time Frame: during surgery
Illumination intensity required during the surgery : scale from 1 (significantly higher) to 5 (significantly lower)
Color appearance evaluation
Time Frame: during surgery
color appearance during the surgery : scale from 1 (far less natural colors) to 5 (far better natural colors )
Secondary Outcomes
No secondary outcomes reported