Cataract3D-HiMCONCT06264830
3D Visualization System in Highly Myopic Cataract Operation
A study testing Alcon-NGENUITY®(NG)-system and Standard cataract operation in people with Cataract and High Myopia, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This study aims to investigate the impact of depth of field differences between the use of the 3D imaging system (NGENUITY® 3D Visualization System, Alcon, TX, USA) and conventional optical microscope in cataract surgery for highly myopic patients on intraoperative parameters and outcomes. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cataract, High Myopia
- What is being tested?
- Alcon-NGENUITY®(NG)-system and Standard cataract operation
- Type of treatment
- 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
- 3 Jul 2024to 31 Dec 2025
- 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
- High myopia (axial length of 26 millimeters or more).
- Presence of clinically significant age-related nuclear cataract requiring surgery, assessed using the International Classification System for Cataract (Lens Opacities Classification System III, LOC III), with a graded score indicating nuclear cataract (LOC III NC/NO grade 3-5).
- Participants must be 20 years of age or older.
Who cannot join
- The target eye has undergone vitrectomy surgery.
- The target eye has undergone corneal refractive surgery.
- Presence of corneal diseases such as corneal dystrophy, corneal trauma, corneal scarring, corneal ulcers, or clinically significant corneal softening that significantly affects the clarity of cataract surgery.
- Complicated cataracts with features such as extreme hardness, complex composition, zonular laxity, lens dislocation, extensive capsular fibrosis, or those falling under the international cataract classification standards LOCIII NO/NC6 or C4-C5 or P4-P5.
- Presence of other non-myopia-related eye diseases significantly affecting the complexity of surgery, such as adhesive uveitis causing adhesions, corneal damage due to trauma or lens dislocation, structural changes and adhesions due to intraocular inflammation, or severe uncorrected strabismus affecting eye alignment.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Ophthalmology, National Taiwan University Hospital
Taipei, 100
About this study
Official title: Comparing the Effect of Depth of Focus Difference in High Myopic Patients Receiving Cataract Operations Between 3D Visualization System and Traditional Optical Microscope.
This study aims to investigate the impact of depth of field differences between the use of the 3D imaging system (NGENUITY® 3D Visualization System, Alcon, TX, USA) and conventional optical microscope in cataract surgery for highly myopic patients on intraoperative parameters and outcomes.
Read the detailed description
The objective of this study is to compare the surgical outcomes and parameters between cataract surgeries performed using the NGENUITY® 3D Visualization System (Alcon, TX, USA), a 3D imaging system, and the current standard binocular microscope in highly myopic patients. The focus is on evaluating the differences in depth of field and their impact on intraoperative parameters and outcomes.
This prospective randomized controlled trial aims to enroll patients with both high myopia and cataracts requiring surgical intervention. Participants will be randomly assigned to undergo cataract surgery using the current standard binocular microscope (control group) or the NGENUITY® 3D Visualization System (Alcon, TX, USA) (study group). The study will compare intraoperative parameters, surgical outcomes, and the incidence of potential complications, including the frequency of microscope adjustments during surgery, total distance of adjustments during surgery, distance needed to achieve clear focus from the corneal surface to the posterior capsule, surgical duration, cumulative ultrasound energy during surgery, and occurrence of surgical complications.
- Conditions
- Cataract, High Myopia
- Being tested
- Alcon-NGENUITY®(NG)-system, Standard cataract operation
- Keywords
- Cataract, High Myopia, Digital 3D System, Depth of Field
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcon-NGENUITY®(NG)-systemDevice
During operation, the Alcon NGENUITY® (NG) System is mounted on microscope, while the surgeon will wear 3D glasses, watch 3D screen, and perform operation
Standard cataract operationProcedure or surgery
Standard, modern cataract extraction with standard phacoemulsification technique, and posterior chamber intraocular lens implantation.
| Study group | Role | What they receive |
|---|---|---|
| Conventional-binocular-microscope-assisted standard cataract operation | Active comparator | In this group, patients undergo standard modern cataract operation during which the surgeon use conventional binocular microscope Receives: Procedure: Standard cataract operation |
| Alcon-NGENUITY® (NG)-System-assisted standard cataract operation | Experimental | In this group, patients undergo standard modern cataract operation during which the surgeon use the Alcon NGENUITY® (NG) System Receives: Device: Alcon-NGENUITY®(NG)-system; Procedure: Standard cataract operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of times of Microscopic focus adjustment, measured by counting from the video recordings
A video recorder will focus on the sliding joint between main suspension arm of microscope and its lens system. Once the surgeon change the focus, the marks on both side of the joint will change their relative positions. The times of changes will be counted from the video recording.
Measured: Throughout operation
Secondary outcomes (8)
Distance of subjective focus change in millimeter between corneal surface and surface of posterior capsule, measured by ruler set on microscope
On the microscope one ruler will place on the suspension arm of microscope just beside the sliding joint of main optic lens system. On the side of main optic lens system, there will be a mark. When the surgeon change the focus of the microscope. The mark will change its position relative to the ruler with millimeter in scale. Distance in millimeter of subjective focus between corneal surface and surface of posterior capsule can thus be measured.
Measured: During the operation, immediately after lens material is removed, and immediately before the intraocular lens is implanted.
Total moving distance in millimeter of microscope-lens-system relative to suspension arm, measured by ruler set on microscope
On the microscope one ruler will place on the suspension arm of microscope just beside the sliding joint of main optic lens system. On the side of main optic lens system, there will be a mark. When the surgeon change the focus of microscope. The mark will change its position relative to the ruler with millimeter in scale. The total moving distance is the add-ups of all changes during operation in absolute value.
Measured: Throughout operation
Total operation time
Total operation time
Measured: Throughout operation
Cumulative dissipated energy (CDE) of phacoemulsification, that is automatically measured and demonstrated on the screen of phacoemulsification machine (Centurion)
Cumulative dissipated energy (CDE) is defined as mean phaco power times phaco time. CDE will be automatically measured and calculated by the Alcon centurion phacoemulsification machine, and will be demonstrated on the screen of the machine. CDE is itself the unit. The lower the CDE for an operation, the better.
Measured: Throughout operation
Number of Participants with intraoperative complication
Number of Participants with intraoperative complication
Measured: Throughout operation
Best-corrected visual acuity of the operated eye of Participants at each postoperative follow-up within 3 month, measured with Snellen chart under standard condition (6 meters in distance and standard illumination of environment)
The best-corrected visual acuity (BCVA) measured with Snellen chart is expected to range from 20/20(1.0) to 20/400(0.05). The refraction of the eye will be carefully corrected using trial lens. The higher the Snellen-chart value, and better the vision. For worse vison. The BCVA will be documented with able to count finger at certain distance ( such as100 centimeter or 30 centimeter). For even worse one, the BCVA will be documented with able to tell hand waving or not at certain distance ( such as100 centimeter or 30 centimeter). For even worse one, the BCVA will be documented with light perception or no light perception.
Measured: Within 3 month after operation, at postoperative day1, at postoperative week 1, at post operative month 1, at post operative month 3
Number of Participants with post-operative complication
Number of Participants with post-operative complication
Measured: Within three month after operation, at postoperative day1, at postoperative week 1, at post operative month 1, at post operative month 3
Intraocular pressure of the operated eye of participants at each postoperative follow-up within 3 month, measured with pneumatic tonometer
The intraocular pressure will be measured with pneumatic tonometer
Measured: Within 3 month after operation, at postoperative day1, at postoperative week 1, at post operative month 1, at post operative month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start3 Jul 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for CataractStudies 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
- None (open label)
- 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
- Tzyy-Chang Ho, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06264830
- Sponsor's protocol ID
- 202307103DIPC
- Acronym
- 3D-HiMCO
- Status last verified
- Aug 2026
- First submitted
- 21 Jan 2024
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Hamasaki I, Shibata K, Shimizu T, Kono R, Morizane Y, Shiraga F. Lights-out Surgery for Strabismus Using a Heads-Up 3D Vision System. Acta Med Okayama. 2019 Jun;73(3):229-233. doi: 10.18926/AMO/56865.
PubMed 31235970Weinstock RJ, Diakonis VF, Schwartz AJ, Weinstock AJ. Heads-up Cataract Surgery: Complication Rates, Surgical Duration, and Comparison With Traditional Microscopes. J Refract Surg. 2019 May 1;35(5):318-322. doi: 10.3928/1081597X-20190410-02.
PubMed 31059581Kita M, Mori Y, Hama S. Hybrid wide-angle viewing-endoscopic vitrectomy using a 3D visualization system. Clin Ophthalmol. 2018 Feb 12;12:313-317. doi: 10.2147/OPTH.S156497. eCollection 2018.
PubMed 29491704Skinner CC, Riemann CD. "HEADS UP" DIGITALLY ASSISTED SURGICAL VIEWING FOR RETINAL DETACHMENT REPAIR IN A PATIENT WITH SEVERE KYPHOSIS. Retin Cases Brief Rep. 2018 Summer;12(3):257-259. doi: 10.1097/ICB.0000000000000486.
PubMed 27841831Coppola M, La Spina C, Rabiolo A, Querques G, Bandello F. Heads-up 3D vision system for retinal detachment surgery. Int J Retina Vitreous. 2017 Nov 20;3:46. doi: 10.1186/s40942-017-0099-2. eCollection 2017.
PubMed 29188074Wai YZ, Fiona Chew LM, Mohamad AS, Ang CL, Chong YY, Adnan TH, Goh PP. The Malaysian cataract surgery registry: incidence and risk factors of postoperative infectious endophthalmitis over a 7-year period. Int J Ophthalmol. 2018 Oct 18;11(10):1685-1690. doi: 10.18240/ijo.2018.10.17. eCollection 2018.
PubMed 30364221Qian Z, Wang H, Fan H, Lin D, Li W. Three-dimensional digital visualization of phacoemulsification and intraocular lens implantation. Indian J Ophthalmol. 2019 Mar;67(3):341-343. doi: 10.4103/ijo.IJO_1012_18.
PubMed 30777950Ramirez Mejia M, Arroyo Munoz L, Medina Perez AB, Mendoza Velasquez C, Ceja Martinez J, Camacho Ordonez A, Guerrero-Berger O. Magnification and Refocusing Comparison in Cataract Surgery Using a Heads-Up Three-Dimensional Visualization System versus Conventional Binocular Microscopy. Clin Ophthalmol. 2023 Aug 15;17:2333-2339. doi: 10.2147/OPTH.S423372. eCollection 2023.
PubMed 37600146Kelkar JA, Kelkar AS, Bolisetty M. Initial experience with three-dimensional heads-up display system for cataract surgery - A comparative study. Indian J Ophthalmol. 2021 Sep;69(9):2304-2309. doi: 10.4103/ijo.IJO_231_21.
PubMed 34427206Liu J, Wu D, Ren X, Li X. Clinical experience of using the NGENUITY three-dimensional surgery system in ophthalmic surgical procedures. Acta Ophthalmol. 2021 Feb;99(1):e101-e108. doi: 10.1111/aos.14518. Epub 2020 Jul 9.
PubMed 32643263
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effect of Depth of Focus Difference in High Myopic Patients Receiving Cataract Operations Between 3D Visualization System and Traditional Optical Microscope.
- ClinicalTrials.gov ID
- NCT06264830
- Acronym / sponsor ID
- 3D-HiMCO / 202307103DIPC
- Conditions
- Cataract, High Myopia
- Keywords
- Cataract, High Myopia, Digital 3D System, Depth of Field
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 3 Jul 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 20 Feb 2024 (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.
This study aims to investigate the impact of depth of field differences between the use of the 3D imaging system (NGENUITY® 3D Visualization System, Alcon, TX, USA) and conventional optical microscope in cataract surgery for highly myopic patients on intraoperative parameters and outcomes.
Detailed description
The objective of this study is to compare the surgical outcomes and parameters between cataract surgeries performed using the NGENUITY® 3D Visualization System (Alcon, TX, USA), a 3D imaging system, and the current standard binocular microscope in highly myopic patients. The focus is on evaluating the differences in depth of field and their impact on intraoperative parameters and outcomes.
This prospective randomized controlled trial aims to enroll patients with both high myopia and cataracts requiring surgical intervention. Participants will be randomly assigned to undergo cataract surgery using the current standard binocular microscope (control group) or the NGENUITY® 3D Visualization System (Alcon, TX, USA) (study group). The study will compare intraoperative parameters, surgical outcomes, and the incidence of potential complications, including the frequency of microscope adjustments during surgery, total distance of adjustments during surgery, distance needed to achieve clear focus from the corneal surface to the posterior capsule, surgical duration, cumulative ultrasound energy during surgery, and occurrence of surgical complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional-binocular-microscope-assisted standard cataract operation | Active comparator | Procedure: Standard cataract operationIn this group, patients undergo standard modern cataract operation during which the surgeon use conventional binocular microscope |
| Alcon-NGENUITY® (NG)-System-assisted standard cataract operation | Experimental | Device: Alcon-NGENUITY®(NG)-system, Procedure: Standard cataract operationIn this group, patients undergo standard modern cataract operation during which the surgeon use the Alcon NGENUITY® (NG) System |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- High myopia (axial length of 26 millimeters or more).
- Presence of clinically significant age-related nuclear cataract requiring surgery, assessed using the International Classification System for Cataract (Lens Opacities Classification System III, LOC III), with a graded score indicating nuclear cataract (LOC III NC/NO grade 3-5).
- Participants must be 20 years of age or older.
Key exclusion criteria (5 listed)
- The target eye has undergone vitrectomy surgery.
- The target eye has undergone corneal refractive surgery.
- Presence of corneal diseases such as corneal dystrophy, corneal trauma, corneal scarring, corneal ulcers, or clinically significant corneal softening that significantly affects the clarity of cataract surgery.
- Complicated cataracts with features such as extreme hardness, complex composition, zonular laxity, lens dislocation, extensive capsular fibrosis, or those falling under the international cataract classification standards LOCIII NO/NC6 or C4-C5 or P4-P5.
- Presence of other non-myopia-related eye diseases significantly affecting the complexity of surgery, such as adhesive uveitis causing adhesions, corneal damage due to trauma or lens dislocation, structural changes and adhesions due to intraocular inflammation, or severe uncorrected strabismus affecting eye alignment.
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 |
|---|---|---|
| Alcon-NGENUITY®(NG)-systemDuring operation, the Alcon NGENUITY® (NG) System is mounted on microscope, while the surgeon will wear 3D glasses, watch 3D screen, and perform operation | Device | Alcon-NGENUITY® (NG)-System-assisted standard cataract operation |
| Standard cataract operationStandard, modern cataract extraction with standard phacoemulsification technique, and posterior chamber intraocular lens implantation. | Procedure or surgery | Alcon-NGENUITY® (NG)-System-assisted standard cataract operation, Conventional-binocular-microscope-assisted standard cataract operation |
Primary outcome
Number of times of Microscopic focus adjustment, measured by counting from the video recordings
Time frame: Throughout operation
A video recorder will focus on the sliding joint between main suspension arm of microscope and its lens system. Once the surgeon change the focus, the marks on both side of the joint will change their relative positions. The times of changes will be counted from the video recording.
8 secondary outcomes
Distance of subjective focus change in millimeter between corneal surface and surface of posterior capsule, measured by ruler set on microscope
Time frame: During the operation, immediately after lens material is removed, and immediately before the intraocular lens is implanted.
Total moving distance in millimeter of microscope-lens-system relative to suspension arm, measured by ruler set on microscope
Time frame: Throughout operation
Total operation time
Time frame: Throughout operation
Cumulative dissipated energy (CDE) of phacoemulsification, that is automatically measured and demonstrated on the screen of phacoemulsification machine (Centurion)
Time frame: Throughout operation
Number of Participants with intraoperative complication
Time frame: Throughout operation
Best-corrected visual acuity of the operated eye of Participants at each postoperative follow-up within 3 month, measured with Snellen chart under standard condition (6 meters in distance and standard illumination of environment)
Time frame: Within 3 month after operation, at postoperative day1, at postoperative week 1, at post operative month 1, at post operative month 3
Number of Participants with post-operative complication
Time frame: Within three month after operation, at postoperative day1, at postoperative week 1, at post operative month 1, at post operative month 3
Intraocular pressure of the operated eye of participants at each postoperative follow-up within 3 month, measured with pneumatic tonometer
Time frame: Within 3 month after operation, at postoperative day1, at postoperative week 1, at post operative month 1, at post operative month 3
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 19 Aug 2026.
- Results publication: PubMed 31235970Hamasaki I, Shibata K, Shimizu T, Kono R, Morizane Y, Shiraga F. Lights-out Surgery for Strabismus Using a Heads-Up 3D Vision System. Acta Med Okayama. 2019 Jun;73(3):229-233. doi: 10.18926/AMO/56865.
- Results publication: PubMed 31059581Weinstock RJ, Diakonis VF, Schwartz AJ, Weinstock AJ. Heads-up Cataract Surgery: Complication Rates, Surgical Duration, and Comparison With Traditional Microscopes. J Refract Surg. 2019 May 1;35(5):318-322. doi: 10.3928/1081597X-20190410-02.
- Results publication: PubMed 29491704Kita M, Mori Y, Hama S. Hybrid wide-angle viewing-endoscopic vitrectomy using a 3D visualization system. Clin Ophthalmol. 2018 Feb 12;12:313-317. doi: 10.2147/OPTH.S156497. eCollection 2018.
- Results publication: PubMed 27841831Skinner CC, Riemann CD. "HEADS UP" DIGITALLY ASSISTED SURGICAL VIEWING FOR RETINAL DETACHMENT REPAIR IN A PATIENT WITH SEVERE KYPHOSIS. Retin Cases Brief Rep. 2018 Summer;12(3):257-259. doi: 10.1097/ICB.0000000000000486.
- Results publication: PubMed 29188074Coppola M, La Spina C, Rabiolo A, Querques G, Bandello F. Heads-up 3D vision system for retinal detachment surgery. Int J Retina Vitreous. 2017 Nov 20;3:46. doi: 10.1186/s40942-017-0099-2. eCollection 2017.
- Results publication: PubMed 30364221Wai YZ, Fiona Chew LM, Mohamad AS, Ang CL, Chong YY, Adnan TH, Goh PP. The Malaysian cataract surgery registry: incidence and risk factors of postoperative infectious endophthalmitis over a 7-year period. Int J Ophthalmol. 2018 Oct 18;11(10):1685-1690. doi: 10.18240/ijo.2018.10.17. eCollection 2018.
- Results publication: PubMed 30777950Qian Z, Wang H, Fan H, Lin D, Li W. Three-dimensional digital visualization of phacoemulsification and intraocular lens implantation. Indian J Ophthalmol. 2019 Mar;67(3):341-343. doi: 10.4103/ijo.IJO_1012_18.
- Results publication: PubMed 37600146Ramirez Mejia M, Arroyo Munoz L, Medina Perez AB, Mendoza Velasquez C, Ceja Martinez J, Camacho Ordonez A, Guerrero-Berger O. Magnification and Refocusing Comparison in Cataract Surgery Using a Heads-Up Three-Dimensional Visualization System versus Conventional Binocular Microscopy. Clin Ophthalmol. 2023 Aug 15;17:2333-2339. doi: 10.2147/OPTH.S423372. eCollection 2023.
- Results publication: PubMed 34427206Kelkar JA, Kelkar AS, Bolisetty M. Initial experience with three-dimensional heads-up display system for cataract surgery - A comparative study. Indian J Ophthalmol. 2021 Sep;69(9):2304-2309. doi: 10.4103/ijo.IJO_231_21.
- Results publication: PubMed 32643263Liu J, Wu D, Ren X, Li X. Clinical experience of using the NGENUITY three-dimensional surgery system in ophthalmic surgical procedures. Acta Ophthalmol. 2021 Feb;99(1):e101-e108. doi: 10.1111/aos.14518. Epub 2020 Jul 9.
- Individual participant dataSharing planned: No
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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.
Tzyy-Chang Ho 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 Alcon-NGENUITY®(NG)-system and Standard cataract operation in people with Cataract and High Myopia, 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 5 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 19 Aug 2026. 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 times of Microscopic focus adjustment, measured by counting from the video recordings (time frame: Throughout operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06264830, which also lists 10 linked publications.
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 19 Aug 2026.