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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alcon-NGENUITY®(NG)-system | Device | During operation, the Alcon NGENUITY® (NG) System is mounted on microscope, while the surgeon will wear 3D glasses, watch 3D screen, and perform operation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Throughout operation |
| 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. | Throughout operation |
| 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. | During the operation, immediately after lens material is removed, and immediately before the intraocular lens is implanted. |
| Measure | Description | Time Frame |
|---|---|---|
| Total operation time | Total operation time | Throughout operation |
| Cumulative dissipated energy (CDE) of phacoemulsification, that is automatically measured and demonstrated on the screen of phacoemulsification machine (Centurion) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cheng-Yung Lee, M.D. | Contact | 886-2-23123456 | 65190 | G05875@hch.gov.tw |
| Tzyy-Chang Ho, M.D. | Contact | 886-2-23123456 | 65190 | hotc@ntuh.gov.tw |
| Name | Affiliation | Role |
|---|---|---|
| Tzyy-Chang Ho | National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology, National Taiwan University Hospital | Recruiting | Taipei | 100 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31235970 | Result | 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. | |
| 31059581 | Result | Weinstock 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. |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Standard cataract operation | Procedure | Standard, modern cataract extraction with standard phacoemulsification technique, and posterior chamber intraocular lens implantation. |
|
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.
| Throughout operation |
| Number of Participants with intraoperative complication | Number of Participants with intraoperative complication | 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. | 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 | 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 | Within 3 month after operation, at postoperative day1, at postoperative week 1, at post operative month 1, at post operative month 3 |
| 29491704 | Result | Kita 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. |
| 27841831 | Result | Skinner 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. |
| 29188074 | Result | Coppola 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. |
| 30364221 | Result | Wai 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. |
| 30777950 | Result | Qian 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. |
| 37600146 | Result | Ramirez 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. |
| 34427206 | Result | Kelkar 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. |
| 32643263 | Result | Liu 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. |