Patients With Highly Myopic EyesNCT05367193
3D Visualization System for Vitreoretinal Diseases in Highly Myopic Eyes
A study testing pars plana vitrectomy and NGENUITY® 3D Visualization System (Alcon, TX, USA) in people with Patients With Highly Myopic Eyes, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
To investigate the surgical outcomes and intraoperative parameters evaluation of 3D visualization system for vitreoretinal diseases in highly myopic eyes Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Patients With Highly Myopic Eyes
- What is being tested?
- pars plana vitrectomy and NGENUITY® 3D Visualization System (Alcon, TX, USA)
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Oct 2022to 16 Mar 2023
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Highly myopic patients (axial length ≥ 26mm, no upper limit)
- Patient with vitreoretinal pathology that require vitrectomy who had not received previous ICG or BBG-assisted membrane peeling
- Patient aged ≥ 20 years
Who cannot join
- Patient who had previous ICG or BBG-assisted membrane peeling
- Patient who received combined vitrectomy and trabeculectomy
- Patient with endophthalmitis or intraocular foreign body
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgical Outcomes and Intraoperative Parameters Evaluation of 3D Visualization System for Vitreoretinal Diseases in Highly Myopic Eyes
To investigate the surgical outcomes and intraoperative parameters evaluation of 3D visualization system for vitreoretinal diseases in highly myopic eyes
Read the detailed description
The investigators aimed to compare the safety and efficacy of NGENUITY® 3D Visualization System (Alcon, TX, USA) in vitreoretinal surgery of highly myopic patients with standard binocular microscope pars plana vitrectomy of highly myopic patients. This is a randomized controlled study and will enroll highly myopic patients who had axial length more than 26 mm and needed vitreoretinal surgery. The enrolled patients will be randomized into "NGENUITY® 3D Visualization System (Alcon, TX, USA) group"(trial group) and "standard binocular microscope pars plana vitrectomy group"(controlled group). The investigators will compare the number of injections of dye (indocyanine green (ICG) or brilliant blue G (BBG)), total surgical time, total peeling time, exposure time of dye, power of endoilluminator, the rate of probe bending, surgical time, postoperative intraocular pressure (IOP), the rate of wound leakage, hypotony, subconjunctival hemorrhage, vitreous hemorrhage, retinal hemorrhage, and endophthalmitis, best-corrected visual acuity (BCVA), structural changes shown on OCT and so on between the two groups.
- Conditions
- Patients With Highly Myopic Eyes
- Being tested
- pars plana vitrectomy, NGENUITY® 3D Visualization System (Alcon, TX, USA)
- Keywords
- vitreoretinal surgery, high myopia, Pars plana vitrectomy, 3D visualization system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pars plana vitrectomyProcedure or surgery
pars plana vitrectomy for vitreoretinal disease in highly myopic eyes
NGENUITY® 3D Visualization System (Alcon, TX, USA)Device
Injection of ICG to stain internal limiting membrane
| Study group | Role | What they receive |
|---|---|---|
| pars plana vitrectomy performed using NGENUITY® 3D Visualization System (Alcon, TX, USA) | Experimental | NGENUITY® 3D Visualization System (Alcon, TX, USA) Receives: Procedure: pars plana vitrectomy; Device: NGENUITY® 3D Visualization System (Alcon, TX, USA) |
| standard binocular microscope pars plana vitrectomy | Active comparator | standard binocular microscope pars plana vitrectomy Receives: Procedure: pars plana vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of injections of ICG
Fixed and minimal concentration: ICG (25mg/vial) is diluted to 0.05% Fixed time: Each injection is 15 sec Interval time for washout: consistent as 10 sec
Measured: operation day
Secondary outcomes (3)
Total surgical time
Total surgical time
Measured: Intraoperative
ILM peeling time
ILM peeling time
Measured: operation day
ICG exposure time
ICG exposure time
Measured: operation day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start7 Oct 2022
- Primary completion16 Mar 2023
- Study completion16 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Highly Myopic EyesStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Sponsor
- Investigators
- Ho Tzyy-Chang, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05367193
- Sponsor's protocol ID
- 202110065DINC
- Status last verified
- Nov 2021
- First submitted
- 26 Apr 2022
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data may be provided under reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Outcomes and Intraoperative Parameters Evaluation of 3D Visualization System for Vitreoretinal Diseases in Highly Myopic Eyes
- ClinicalTrials.gov ID
- NCT05367193
- Acronym / sponsor ID
- 202110065DINC
- Conditions
- Patients With Highly Myopic Eyes
- Keywords
- vitreoretinal surgery, high myopia, Pars plana vitrectomy, 3D visualization system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 7 Oct 2022 (actual)
- Primary completion
- 16 Mar 2023 (actual)
- Study completion
- 16 Mar 2023 (actual)
- First posted
- 10 May 2022 (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 investigate the surgical outcomes and intraoperative parameters evaluation of 3D visualization system for vitreoretinal diseases in highly myopic eyes
Detailed description
The investigators aimed to compare the safety and efficacy of NGENUITY® 3D Visualization System (Alcon, TX, USA) in vitreoretinal surgery of highly myopic patients with standard binocular microscope pars plana vitrectomy of highly myopic patients. This is a randomized controlled study and will enroll highly myopic patients who had axial length more than 26 mm and needed vitreoretinal surgery. The enrolled patients will be randomized into "NGENUITY® 3D Visualization System (Alcon, TX, USA) group"(trial group) and "standard binocular microscope pars plana vitrectomy group"(controlled group). The investigators will compare the number of injections of dye (indocyanine green (ICG) or brilliant blue G (BBG)), total surgical time, total peeling time, exposure time of dye, power of endoilluminator, the rate of probe bending, surgical time, postoperative intraocular pressure (IOP), the rate of wound leakage, hypotony, subconjunctival hemorrhage, vitreous hemorrhage, retinal hemorrhage, and endophthalmitis, best-corrected visual acuity (BCVA), structural changes shown on OCT and so on between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pars plana vitrectomy performed using NGENUITY® 3D Visualization System (Alcon, TX, USA) | Experimental | Procedure: pars plana vitrectomy, Device: NGENUITY® 3D Visualization System (Alcon, TX, USA)NGENUITY® 3D Visualization System (Alcon, TX, USA) |
| standard binocular microscope pars plana vitrectomy | Active comparator | Procedure: pars plana vitrectomystandard binocular microscope pars plana vitrectomy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Highly myopic patients (axial length ≥ 26mm, no upper limit)
- Patient with vitreoretinal pathology that require vitrectomy who had not received previous ICG or BBG-assisted membrane peeling
- Patient aged ≥ 20 years
Key exclusion criteria (3 listed)
- Patient who had previous ICG or BBG-assisted membrane peeling
- Patient who received combined vitrectomy and trabeculectomy
- Patient with endophthalmitis or intraocular foreign body
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 |
|---|---|---|
| pars plana vitrectomypars plana vitrectomy for vitreoretinal disease in highly myopic eyes | Procedure or surgery | pars plana vitrectomy performed using NGENUITY® 3D Visualization System (Alcon, TX, USA), standard binocular microscope pars plana vitrectomy |
| NGENUITY® 3D Visualization System (Alcon, TX, USA)Injection of ICG to stain internal limiting membrane | Device | pars plana vitrectomy performed using NGENUITY® 3D Visualization System (Alcon, TX, USA) |
Primary outcome
Number of injections of ICG
Time frame: operation day
Fixed and minimal concentration: ICG (25mg/vial) is diluted to 0.05% Fixed time: Each injection is 15 sec Interval time for washout: consistent as 10 sec
3 secondary outcomes
Total surgical time
Time frame: Intraoperative
ILM peeling time
Time frame: operation day
ICG exposure time
Time frame: operation day
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 17 Jun 2024.
- Individual participant dataSharing planned: No. Data may be provided under reasonable request.
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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.
Ho Tzyy-Chang, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pars plana vitrectomy and NGENUITY® 3D Visualization System (Alcon, TX, USA) in people with Patients With Highly Myopic Eyes, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 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 17 Jun 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 Taiwan. 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?
Number of injections of ICG (time frame: operation day). 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 17 Jun 2024.