Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-26 @ 6:21 AM
Study NCT ID:
NCT03605160
Status:
UNKNOWN
Last Update Posted:
2019-05-29
First Post:
2018-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Innovative Method Fluid-jet to to Remove Residual Lens Fibers
Sponsor:
Sun Yat-sen University
Organization:
Study Overview
Official Title:
Efficacy of Fluid-jet as an Innovative Method to Prevent Posterior Capsular Opacity After Phacoemulsification
Status:
UNKNOWN
Status Verified Date:
2019-05
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Residual lens fibers (RLFs) on the posterior lens capsule during cataract surgery can cause after cataract, affecting visual quality and increasing the medical cost for further laser posterior capsulotomy. However, conventional polish is inconvenient and time-consuming. We use an innovative fluid-jet method to remove RLFs, and compare the efficacy of fluid-jet and polish to prevent posterior capsular opacity after phacoemulsification.
Detailed Description:
Purpose: Residual lens fibers (RLFs) on the posterior lens capsule during cataract surgery can cause after cataract, affecting visual quality and increasing the medical cost for further laser posterior capsulotomy. However, conventional polish is inconvenient and time-consuming. We use an innovative fluid-jet method to remove RLFs, and compare the efficacy of fluid-jet and polish to prevent posterior capsular opacity after phacoemulsification.
Design: Single-center, prospective, randomized controlled clinical study Subjects of study: Age-related cataract patients receiving phacoemulsification from Zhongshan Ophthalmic Center, Guangzhou, China.
Methods: patients are 1: 1 randomized to two groups. Polish group: After irrigation and aspiration (I/A), the RLFs on the posterior capsule are removed by polishing before intraocular lens (IOL) implantation; Fluid-jet group: Polish is not performed. RLFs on posterior capsule are removed by jetting fluid with an irrigating syringe after IOL implantation. The posterior capsular images of all the patients are obtained immediately before and after IOL implantation, and at the end of surgery, then the amount of RLFs is quantitatively analyzed by using LYZ-PCO, a software we developed. Best corrected visual acuity and parameters of visual quality, such as objective scattering index(OSI), Strehl ratio (SR) and Modulation Transfer Function (Mtf)-cut off are evaluated by objective visual quality analyser (OQAS) at 1 day, 1 week and 1 year after surgery. The patients receives telephone follow-up every month. The severity of posterior capsular opacification (PCO) and incidence of laser posterior capsulotomy is recorded.
Main indicators for the study: The incidence of laser posterior capsulotomy a year after surgery.
Design: Single-center, prospective, randomized controlled clinical study Subjects of study: Age-related cataract patients receiving phacoemulsification from Zhongshan Ophthalmic Center, Guangzhou, China.
Methods: patients are 1: 1 randomized to two groups. Polish group: After irrigation and aspiration (I/A), the RLFs on the posterior capsule are removed by polishing before intraocular lens (IOL) implantation; Fluid-jet group: Polish is not performed. RLFs on posterior capsule are removed by jetting fluid with an irrigating syringe after IOL implantation. The posterior capsular images of all the patients are obtained immediately before and after IOL implantation, and at the end of surgery, then the amount of RLFs is quantitatively analyzed by using LYZ-PCO, a software we developed. Best corrected visual acuity and parameters of visual quality, such as objective scattering index(OSI), Strehl ratio (SR) and Modulation Transfer Function (Mtf)-cut off are evaluated by objective visual quality analyser (OQAS) at 1 day, 1 week and 1 year after surgery. The patients receives telephone follow-up every month. The severity of posterior capsular opacification (PCO) and incidence of laser posterior capsulotomy is recorded.
Main indicators for the study: The incidence of laser posterior capsulotomy a year after surgery.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: