Clinical Performance and Surgeon Acceptability of a New Dual Mode Phacoemulsification System
Gabriel Quesada,1 Daniel H Chang,2 Kevin L Waltz,3 Andrew A Kao,2 Rodrigo Quesada,1 Ying Wang,4 Leilei Ji,4 Dari Parizadeh,4 Luis Atiles4 1Grupo Oftalmo & Plastico, San Salvador, El Salvador; 2Empire Eye and Laser Center, Bakersfield, CA, USA; 3Central American Ophthalmic Research Consultants, I...
| Main Authors: | , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Dove Medical Press
2022-08-01
|
| Series: | Clinical Ophthalmology |
| Subjects: | |
| Online Access: | https://www.dovepress.com/clinical-performance-and-surgeon-acceptability-of-a-new-dual-mode-phac-peer-reviewed-fulltext-article-OPTH |
| _version_ | 1828325022332092416 |
|---|---|
| author | Quesada G Chang DH Waltz KL Kao AA Quesada R Wang Y Ji L Parizadeh D Atiles L |
| author_facet | Quesada G Chang DH Waltz KL Kao AA Quesada R Wang Y Ji L Parizadeh D Atiles L |
| author_sort | Quesada G |
| collection | DOAJ |
| description | Gabriel Quesada,1 Daniel H Chang,2 Kevin L Waltz,3 Andrew A Kao,2 Rodrigo Quesada,1 Ying Wang,4 Leilei Ji,4 Dari Parizadeh,4 Luis Atiles4 1Grupo Oftalmo & Plastico, San Salvador, El Salvador; 2Empire Eye and Laser Center, Bakersfield, CA, USA; 3Central American Ophthalmic Research Consultants, Indianapolis, IN, USA; 4Johnson & Johnson Surgical Vision, Inc, Santa Ana, CA, USACorrespondence: Gabriel Quesada, Grupo Oftalmo & Plastico, 9 C Pte, 4625, Col Escalon, San Salvador, El Salvador, Tel +1 (503) 22579003, Email gabriel.quesadalarez@gmail.comPurpose: The purpose of this first in-human study was to evaluate the overall clinical performance of the VERITAS™ Vision System in patients scheduled to undergo cataract extraction and to confirm overall surgeon acceptability.Patients and methods: This prospective, open-label multinational study included adults with cataracts scheduled for planned cataract extraction and posterior chamber IOL implantation. Standard small-incision phacoemulsification cataract surgery with the VERITAS Vision System was conducted. Surgeons completed a questionnaire regarding their clinical experience with the VERITAS Vision System for each patient following surgery and 1-day postoperative. Corneal clarity and adverse events (AEs) were assessed. Surgeon acceptability was scored on a 5-point scale, with acceptability considered favorable for scores of 4 and 5.Results: A total of 115 eyes (79 patients) were treated. The El Salvador site treated 41 patients (58 eyes), and the US site treated 38 patients (57 eyes). Overall, surgeons were satisfied with the clinical performance regardless of the cataract grade. The satisfaction with anterior chamber stability, post-occlusion surge, followability, holdability, cutting efficiency, usability, and overall satisfaction with the VERITAS Vision System was clinically favorable in ≥ 99% of cases. Overall satisfaction with the swivel handpiece, foot pedal, and enhanced ergonomics were clinically favorable in ≥ 97% of cases regardless of the cataract grade. Satisfaction with corneal clarity at same-day postoperative and 1-day postoperative, and 1-day overall clinical results of surgery with the VERITAS Vision System were clinically favorable in ≥ 94% of cases regardless of cataract grade.Conclusion: The new dual-mode phacoemulsification system with dual-durometer tubing, gas forced infusion, new swivel handpiece, and ergonomics improvements resulted in a high rate of user satisfaction with clinical performance and ergonomics. The VERITAS Vision System is safe and effective when used as indicated.Keywords: VERITAS Vision System, cataract, ergonomics, fluidics, satisfaction |
| first_indexed | 2024-04-13T19:16:02Z |
| format | Article |
| id | doaj.art-c64e0e2532ed456d90366027536afa3a |
| institution | Directory Open Access Journal |
| issn | 1177-5483 |
| language | English |
| last_indexed | 2024-04-13T19:16:02Z |
| publishDate | 2022-08-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | Clinical Ophthalmology |
| spelling | doaj.art-c64e0e2532ed456d90366027536afa3a2022-12-22T02:33:41ZengDove Medical PressClinical Ophthalmology1177-54832022-08-01Volume 162441245177160Clinical Performance and Surgeon Acceptability of a New Dual Mode Phacoemulsification SystemQuesada GChang DHWaltz KLKao AAQuesada RWang YJi LParizadeh DAtiles LGabriel Quesada,1 Daniel H Chang,2 Kevin L Waltz,3 Andrew A Kao,2 Rodrigo Quesada,1 Ying Wang,4 Leilei Ji,4 Dari Parizadeh,4 Luis Atiles4 1Grupo Oftalmo & Plastico, San Salvador, El Salvador; 2Empire Eye and Laser Center, Bakersfield, CA, USA; 3Central American Ophthalmic Research Consultants, Indianapolis, IN, USA; 4Johnson & Johnson Surgical Vision, Inc, Santa Ana, CA, USACorrespondence: Gabriel Quesada, Grupo Oftalmo & Plastico, 9 C Pte, 4625, Col Escalon, San Salvador, El Salvador, Tel +1 (503) 22579003, Email gabriel.quesadalarez@gmail.comPurpose: The purpose of this first in-human study was to evaluate the overall clinical performance of the VERITAS™ Vision System in patients scheduled to undergo cataract extraction and to confirm overall surgeon acceptability.Patients and methods: This prospective, open-label multinational study included adults with cataracts scheduled for planned cataract extraction and posterior chamber IOL implantation. Standard small-incision phacoemulsification cataract surgery with the VERITAS Vision System was conducted. Surgeons completed a questionnaire regarding their clinical experience with the VERITAS Vision System for each patient following surgery and 1-day postoperative. Corneal clarity and adverse events (AEs) were assessed. Surgeon acceptability was scored on a 5-point scale, with acceptability considered favorable for scores of 4 and 5.Results: A total of 115 eyes (79 patients) were treated. The El Salvador site treated 41 patients (58 eyes), and the US site treated 38 patients (57 eyes). Overall, surgeons were satisfied with the clinical performance regardless of the cataract grade. The satisfaction with anterior chamber stability, post-occlusion surge, followability, holdability, cutting efficiency, usability, and overall satisfaction with the VERITAS Vision System was clinically favorable in ≥ 99% of cases. Overall satisfaction with the swivel handpiece, foot pedal, and enhanced ergonomics were clinically favorable in ≥ 97% of cases regardless of the cataract grade. Satisfaction with corneal clarity at same-day postoperative and 1-day postoperative, and 1-day overall clinical results of surgery with the VERITAS Vision System were clinically favorable in ≥ 94% of cases regardless of cataract grade.Conclusion: The new dual-mode phacoemulsification system with dual-durometer tubing, gas forced infusion, new swivel handpiece, and ergonomics improvements resulted in a high rate of user satisfaction with clinical performance and ergonomics. The VERITAS Vision System is safe and effective when used as indicated.Keywords: VERITAS Vision System, cataract, ergonomics, fluidics, satisfactionhttps://www.dovepress.com/clinical-performance-and-surgeon-acceptability-of-a-new-dual-mode-phac-peer-reviewed-fulltext-article-OPTHveritas vision systemcataractergonomicsfluidicssatisfaction |
| spellingShingle | Quesada G Chang DH Waltz KL Kao AA Quesada R Wang Y Ji L Parizadeh D Atiles L Clinical Performance and Surgeon Acceptability of a New Dual Mode Phacoemulsification System Clinical Ophthalmology veritas vision system cataract ergonomics fluidics satisfaction |
| title | Clinical Performance and Surgeon Acceptability of a New Dual Mode Phacoemulsification System |
| title_full | Clinical Performance and Surgeon Acceptability of a New Dual Mode Phacoemulsification System |
| title_fullStr | Clinical Performance and Surgeon Acceptability of a New Dual Mode Phacoemulsification System |
| title_full_unstemmed | Clinical Performance and Surgeon Acceptability of a New Dual Mode Phacoemulsification System |
| title_short | Clinical Performance and Surgeon Acceptability of a New Dual Mode Phacoemulsification System |
| title_sort | clinical performance and surgeon acceptability of a new dual mode phacoemulsification system |
| topic | veritas vision system cataract ergonomics fluidics satisfaction |
| url | https://www.dovepress.com/clinical-performance-and-surgeon-acceptability-of-a-new-dual-mode-phac-peer-reviewed-fulltext-article-OPTH |
| work_keys_str_mv | AT quesadag clinicalperformanceandsurgeonacceptabilityofanewdualmodephacoemulsificationsystem AT changdh clinicalperformanceandsurgeonacceptabilityofanewdualmodephacoemulsificationsystem AT waltzkl clinicalperformanceandsurgeonacceptabilityofanewdualmodephacoemulsificationsystem AT kaoaa clinicalperformanceandsurgeonacceptabilityofanewdualmodephacoemulsificationsystem AT quesadar clinicalperformanceandsurgeonacceptabilityofanewdualmodephacoemulsificationsystem AT wangy clinicalperformanceandsurgeonacceptabilityofanewdualmodephacoemulsificationsystem AT jil clinicalperformanceandsurgeonacceptabilityofanewdualmodephacoemulsificationsystem AT parizadehd clinicalperformanceandsurgeonacceptabilityofanewdualmodephacoemulsificationsystem AT atilesl clinicalperformanceandsurgeonacceptabilityofanewdualmodephacoemulsificationsystem |