Zeiss RESIGHT Disposable Lenses Evaluation Study

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.

Official Title
-----------------
Zeiss RESIGHT Disposable Lenses Evaluation Study: Investigator-initiated, Mono-center, Academic, Prospective, Interventional Case Study

Conditions
-----------------
Retinal Detachment, Macular Pucker, Macular Holes, Vitreomacular Traction

Intervention / Treatment
-----------------
* Device: ZEISS disposable


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group 1<br>primary vitrectomy surgery for retinal detachment | Device: ZEISS disposable<br>* a comparison will be done between the present lenses used (reusable RESIGHT lenses and disposable Vitreq contact lens) and the new disposable RESIGHT lenses.<br>|
| Active Comparator: group 2<br>macular surgery: pucker, vitreomacular traction or macular hole | Device: ZEISS disposable<br>* a comparison will be done between the present lenses used (reusable RESIGHT lenses and disposable Vitreq contact lens) and the new disposable RESIGHT lenses.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 |