Comparison of 3D Visualization and Microscope for VR SurgeryNCT05113212
Damages From Macular Grasping During Vitrectomy Comparing Traditional and 3D Microscope
A study testing Macular surgery with NGENUITY surgical display system and Macular surgery with standard operating microscope in people with Comparison of 3D Visualization and Microscope for VR Surgery, run by Anna Rita Daniele, MD at 1 site in Italy.
Trial summary
Randomized, prospective, descriptive and comparative clinical study. The comparison is between a group of patients affected by macular pucker or macular hole, whose macular peeling is performed using a traditional optical microscope (Leica F40) - control arm, and a group of patients affected by macular pucker or… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Comparison of 3D Visualization and Microscope for VR Surgery
- What is being tested?
- Macular surgery with NGENUITY surgical display system and Macular surgery with standard operating microscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteItaly
- Study dates
- 19 Nov 2021to 30 Sep 2022
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients affected by macular pucker or macular hole, whose internal limiting membrane peeling need to be performed
- Willing and able to understand and sign an informed consent
- Willing and able to undergo postoperative examinations of the protocol program:
- ≥ 21 years of age, of both sexes and any race
Who cannot join
- History of ocular trauma or amblyopia.
- Other ocular pathologies (glaucoma, uveitis, diabetic retinopathy, diabetic macular edema, macular degeneration, Irvine Gass Syndrome, degenerative myopia, malformation of the optic disc, i.e.: tilted disc, optic disc pit, posterior staphyloma)
- Multiple procedures programmed during the surgery
- Pregnancy, lactation or programmed pregnancy during the course of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Prospective, Descriptive and Comparative Clinical Study of Macular Grasping Damage in Patients Undergoing Pars Plana Vitrectomy and Peeling of the Internal Limiting Membrane, Operated by Traditional Microscope or NGENUITY® 3D Visualization System With Heads-up Display System. A Pilot Study.
Randomized, prospective, descriptive and comparative clinical study. The comparison is between a group of patients affected by macular pucker or macular hole, whose macular peeling is performed using a traditional optical microscope (Leica F40) - control arm, and a group of patients affected by macular pucker or macular hole whose macular peeling is performed by 3D heads-up microscopy system (NGenuity 3D, Alcon) - experimental arm.
It is a blind study for both the operator that collects data and for the statistician.
- Being tested
- Macular surgery with NGENUITY surgical display system, Macular surgery with standard operating microscope
- Keywords
- Ngenuity, VR Surgery, Pucker, Macular Hole
- Medical subject headings
- Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macular surgery with NGENUITY surgical display systemDevice
Patient undergoes VR surgery with visualization using heads up display 3D monitor viewed by the operating surgeon
Macular surgery with standard operating microscopeDevice
Patient undergoes VR surgery with visualization using standard operating microscope
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Active comparator | patients affected by macular pucker or macular hole, whose internal limiting membrane peeling is performed using a traditional optical microscope (Leica F40) Receives: Device: Macular surgery with standard operating microscope |
| Experimental arm | Experimental | patients affected by macular pucker or macular hole whose internal limiting membrane peeling is performed by 3D heads-up microscopy system (NGenuity 3D) Receives: Device: Macular surgery with NGENUITY surgical display system |
What is being measured
The primary outcome is the main question the study is designed to answer.
SANFL detection
Post-surgical analysis of SANFL (Swelling of the Arcuate Nerve Fiber Layer) measured on infrared, blue auto-fluorescence images and OCT images of peripapillary region
Measured: 2 weeks after surgery
Secondary outcomes (6)
Intraoperative time
Mean duration of the surgical procedure
Measured: during surgery
ILM staining
Number of internal limiting membrane staining procedures necessary
Measured: during surgery
ILM grasping
Number of ILM grasping attempts.
Measured: during surgery
Light
Lumen of light used
Measured: during surgery
Surgeon ergonomics
Number of episodes of both back and neck pain
Measured: during surgery
BCVA
Best Corrected Visual Acuity
Measured: baseline, 1 month and 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start19 Nov 2021
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comparison of 3D Visualization and Microscope for VR SurgeryStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Dual-arm, pilot, randomized, prospective, descriptive and comparative clinical study
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anna Rita Daniele, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Sponsor-investigator, Anna Rita Daniele, MD, Santa Maria della Misericordia Rovigo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05113212
- Sponsor's protocol ID
- 2997CESC
- Status last verified
- Dec 2022
- First submitted
- 11 Oct 2021
- Last updated
- 22 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Prospective, Descriptive and Comparative Clinical Study of Macular Grasping Damage in Patients Undergoing Pars Plana Vitrectomy and Peeling of the Internal Limiting Membrane, Operated by Traditional Microscope or NGENUITY® 3D Visualization System With Heads-up Display System. A Pilot Study.
- ClinicalTrials.gov ID
- NCT05113212
- Acronym / sponsor ID
- 2997CESC
- Keywords
- Ngenuity, VR Surgery, Pucker, Macular Hole
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Anna Rita Daniele, MDUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 19 Nov 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 9 Nov 2021 (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.
Randomized, prospective, descriptive and comparative clinical study. The comparison is between a group of patients affected by macular pucker or macular hole, whose macular peeling is performed using a traditional optical microscope (Leica F40) - control arm, and a group of patients affected by macular pucker or macular hole whose macular peeling is performed by 3D heads-up microscopy system (NGenuity 3D, Alcon) - experimental arm.
It is a blind study for both the operator that collects data and for the statistician.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Dual-arm, pilot, randomized, prospective, descriptive and comparative clinical study
| Arm | Type | Receives |
|---|---|---|
| Control arm | Active comparator | Device: Macular surgery with standard operating microscopepatients affected by macular pucker or macular hole, whose internal limiting membrane peeling is performed using a traditional optical microscope (Leica F40) |
| Experimental arm | Experimental | Device: Macular surgery with NGENUITY surgical display systempatients affected by macular pucker or macular hole whose internal limiting membrane peeling is performed by 3D heads-up microscopy system (NGenuity 3D) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients affected by macular pucker or macular hole, whose internal limiting membrane peeling need to be performed
- Willing and able to understand and sign an informed consent
- Willing and able to undergo postoperative examinations of the protocol program:
- ≥ 21 years of age, of both sexes and any race
Key exclusion criteria (4 listed)
- History of ocular trauma or amblyopia.
- Other ocular pathologies (glaucoma, uveitis, diabetic retinopathy, diabetic macular edema, macular degeneration, Irvine Gass Syndrome, degenerative myopia, malformation of the optic disc, i.e.: tilted disc, optic disc pit, posterior staphyloma)
- Multiple procedures programmed during the surgery
- Pregnancy, lactation or programmed pregnancy during the course of the study.
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 |
|---|---|---|
| Macular surgery with NGENUITY surgical display systemPatient undergoes VR surgery with visualization using heads up display 3D monitor viewed by the operating surgeon | Device | Experimental arm |
| Macular surgery with standard operating microscopePatient undergoes VR surgery with visualization using standard operating microscope | Device | Control arm |
Primary outcome
SANFL detection
Time frame: 2 weeks after surgery
Post-surgical analysis of SANFL (Swelling of the Arcuate Nerve Fiber Layer) measured on infrared, blue auto-fluorescence images and OCT images of peripapillary region
6 secondary outcomes
Intraoperative time
Time frame: during surgery
ILM staining
Time frame: during surgery
ILM grasping
Time frame: during surgery
Light
Time frame: during surgery
Surgeon ergonomics
Time frame: during surgery
BCVA
Time frame: baseline, 1 month and 3 months after surgery
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 22 Dec 2022.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Macular surgery with NGENUITY surgical display system and Macular surgery with standard operating microscope in people with Comparison of 3D Visualization and Microscope for VR Surgery, run by Anna Rita Daniele, MD at 1 site in Italy.
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 4 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 22 Dec 2022. 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 Italy. 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?
SANFL detection (time frame: 2 weeks after surgery). 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 22 Dec 2022.