An interventional study of ZEISS disposable in Retinal Detachment, Macular Pucker and Macular Holes, sponsored by Universitaire Ziekenhuizen KU Leuven. Completed at 1 site in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-26.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Not applicable, Interventional, and Other
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.
199 studies on the registry are indexed under Retinal Detachment; 29 are open to participants now.
This study's enrollment of 120 is above the median of 50 across 132 interventional studies indexed under Retinal Detachment.
Browse Retinal Detachment studies →Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 963 studies on the registry; 267 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
primary vitrectomy surgery for retinal detachment
Device: ZEISS disposable
macular surgery: pucker, vitreomacular traction or macular hole
Device: ZEISS 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.
Ultra Wide Field lens View Angle evaluation
Ultra Wide Field lens View Angle: scale from 1 (far more indentation) to 5 (far less indentation)
Time frame: during surgery
Ultra Wide Field lens Condensation evaluation
Ultra Wide Field lens Condensation: scale from 1 (far more condensation) to 5 (far less condensation)
Time frame: during surgery
Wide Angle lens Condensation evaluation
Wide Angle lens Condensation: scale from 1 (far more condensation ) to 5 (far less condensation)
Time frame: during surgery
Illumination appearance evaluation
Illumination intensity required during the surgery : scale from 1 (significantly higher) to 5 (significantly lower)
Time frame: during surgery
Color appearance evaluation
color appearance during the surgery : scale from 1 (far less natural colors) to 5 (far better natural colors )
Time frame: during surgery
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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