NCT03605160

An Innovative Method Fluid-jet to to Remove Residual Lens Fibers

Efficacy of Fluid-jet as an Innovative Method to Prevent Posterior Capsular Opacity After Phacoemulsification

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 740 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Posterior Capsule Opacification

Interventions

Type	Name	Description
PROCEDURE	traditional polish	After phacoemulsification and I/A, switch to polish mode and use I/A instrument to remove the RLFs visible on the posterior capsule before injection of viscoelastic agent. IOP: 55mmHg; Aspiration: 0-10; Vacuum: 0-20. The standard for stopping polish is that the RLFs can no longer be absorbed by the side holes on the I/A instrument in this mode, or there are no discernible RLFs on the posterior capsule. If RLFs on the posterior capsular are found after IOL implantation, polish to remove them after the removal of viscoelastic agents.
PROCEDURE	fluid-jet	After phacoemulsification and I/A, inject viscoelastic agent and implant IOL without polish. Use I/A instrument to remove viscoelastic agent. A 27G irrigating syringe was used, and the RLFs on the posterior capsule were gently aligned to make a fluid-jet basically parallel to the iris. The liquid pressure of 50-120 mmHg is produced. The standard for stopping in this mode is that the RLFs can no longer be washed down from the capsule, or there are no discernible RLFs on the posterior capsule.

Timeline

• Start date: 2018-01-01
• Primary completion: 2023-01-01
• Completion: 2023-01-01
• First posted: 2018-07-30
• Last updated: 2019-05-29

Locations

1 site across 1 country: China