NCT04171518|CompletedFDA Device
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Sponsor study identifier
observational
139
1 country
1
Study Start
November 22, 2019
Actual (reported)Primary Completion
October 12, 2020
Actual (reported)Study Completion
October 12, 2020
Actual (reported)This study is a prospective, single-arm, observational study of the Catalys Precision Laser System in real-world clinical practice. The study will be conducted at one site at the Boao Super Hospital in Lecheng International Medical Tourism Pilot Zone of Hainan province in China. The study is being conducted to evaluate the overall performance of the Catalys Precision Laser System. One or both eyes of each subject will be included in study. The Catalys system is used as part of cataract surgery to create LASER cuts as intended by the surgeon to aid in cataract surgery, without adversely impacting the risk to the patient.As such, the endpoints of surgeon rating of completeness of corneal incisions, anterior capsulotomy and phacofragmentation and any device related adverse events from the time of Catalys System use to 1-month postoperative follow-up should adequately cover the evaluation of the intended use of the Catalys System.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 12, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 19, 2019
Actual (reported)November 21, 2019
Actual (reported)November 22, 2019
Actual (reported)October 12, 2020
Actual (reported)October 12, 2020
Actual (reported)Rate of successful anterior capsulotomy
If the investigator is able to remove the capsular disc from the peripheral capsule without the need of manual separation of residual tags, then it will be considered a complete capsulotomy.
Intraoperatively
Rate of successful corneal Incisions
If the investigator is able to blunt dissect the primary incision (without the need for a secondary cutting instrument), then it will be considered a complete cut.
Intraoperatively
Rate of successful phacofragmentation as intended
If there are no error messages or treatment interruptions occur, then phacofragmentation will be considered complete.
Intraoperatively
Cataract Surgery with use of Catalys Precision Laser System
Cataract surgeons to create a precise anterior capsulotomy and/or subsequent fragmentation (phacofragmentation) of the crystalline lens using the Catalys Precision Laser System
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
This study will include subjects undergoing primary cataract extraction and IOL implantation and who meet all the study inclusion and exclusion criteria. Subjects treated during the period of November 2019 to March 2020 (that satisfy the protocol inclusion and exclusion criteria) may be included in the study, or a maximum of 163 subjects (not including the subjects for surgeon certification), whichever comes first. One or both eyes of each subject will be included in study.
Hainan BoAo Super Hospital
BoAo, Hainan, China
Sanjeev Kasthurirangan, Ph.D.
Johnson & Johnson Surgical Vision
139 participants (actual enrollment reported by the registry).
First Submitted
November 19, 2019
First Posted
November 21, 2019
Study Start
November 22, 2019
Actual (reported)Prospective Clinical Study of Unilateral or Bilateral Implantation of Intraocular Lens in Cataract Patients
Contact the study team to confirm eligibility.
Primary Completion
October 12, 2020
Actual (reported)Study Completion
October 12, 2020
Actual (reported)Last Updated
November 30, 2021
Record last verified: 2021-11
Johnson \& Johnson Medical Devices Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA project site at http://yoda.yale.edu
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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