Retinal DetachmentRESIGHTNCT05860985
Zeiss RESIGHT Disposable Lenses Evaluation Study
A study testing ZEISS disposable in people with Retinal Detachment and Macular Pucker, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
To evaluate the intra-operative efficacy of a new intra-operative viewing device. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retinal Detachment, Macular Pucker, Macular Holes
- What is being tested?
- ZEISS disposable
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBelgium
- Study dates
- 11 Apr 2023to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Zeiss RESIGHT Disposable Lenses Evaluation Study: Investigator-initiated, Mono-center, Academic, Prospective, Interventional Case Study
To evaluate the intra-operative efficacy of a new intra-operative viewing device.
Read the 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.
- Being tested
- ZEISS disposable
- Medical subject headings
- Retinal Detachment, Epiretinal Membrane, Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZEISS disposableDevice
a comparison will be done between the present lenses used (reusable RESIGHT lenses and disposable Vitreq contact lens) and the new disposable RESIGHT lenses.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Active comparator | primary vitrectomy surgery for retinal detachment Receives: Device: ZEISS disposable |
| group 2 | Active comparator | macular surgery: pucker, vitreomacular traction or macular hole Receives: Device: ZEISS disposable |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultra Wide Field lens View Angle evaluation
Ultra Wide Field lens View Angle: scale from 1 (far more indentation) to 5 (far less indentation)
Measured: during surgery
Ultra Wide Field lens Condensation evaluation
Ultra Wide Field lens Condensation: scale from 1 (far more condensation) to 5 (far less condensation)
Measured: during surgery
Wide Angle lens Condensation evaluation
Wide Angle lens Condensation: scale from 1 (far more condensation ) to 5 (far less condensation)
Measured: during surgery
Illumination appearance evaluation
Illumination intensity required during the surgery : scale from 1 (significantly higher) to 5 (significantly lower)
Measured: during surgery
Color appearance evaluation
color appearance during the surgery : scale from 1 (far less natural colors) to 5 (far better natural colors )
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start11 Apr 2023
- Primary completion1 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DetachmentStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Stalmans, PhD, MD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05860985
- Sponsor's protocol ID
- S67415
- Acronym
- RESIGHT
- Status last verified
- Aug 2024
- First submitted
- 13 Apr 2023
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zeiss RESIGHT Disposable Lenses Evaluation Study: Investigator-initiated, Mono-center, Academic, Prospective, Interventional Case Study
- ClinicalTrials.gov ID
- NCT05860985
- Acronym / sponsor ID
- RESIGHT / S67415
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Active comparator | Device: ZEISS disposableprimary vitrectomy surgery for retinal detachment |
| group 2 | Active comparator | Device: ZEISS disposablemacular surgery: pucker, vitreomacular traction or macular hole |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZEISS disposablea comparison will be done between the present lenses used (reusable RESIGHT lenses and disposable Vitreq contact lens) and the new disposable RESIGHT lenses. | Device | group 1, group 2 |
Primary outcome
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 )
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Stalmans, PhD, MD principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ZEISS disposable in people with Retinal Detachment and Macular Pucker, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultra Wide Field lens View Angle evaluation (time frame: during surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.