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

Posterior Capsule Opacification Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03605160
• Other study ID #: CCPMOH2018-China-5
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: January 1, 2023

Study information

• Verified date: May 2019
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 740
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Iinclusion criteria:

1) cataract patients aged between 50 and 80 years; 2) graded 5 or less for lens opalescence by the Lens Opacities Classification System, version III (LOCS III); 3) listed for phacoemulsification combined with intraocular lens implantation in topical anesthesia; 4) Signed informed consent.

Exclusion criteria:

1) a history ophthalmic trauma or surgery; 2) other ophthalmic diseases such as glaucoma, uveitis, high myopia; 3) diabetes requiring medical control; 4) disagree with follow-up monitoring; 5) Other factors inappropriate to participate in this project, including but not limited to severe cataracts, very shallow anterior chambers, etc.

Related Conditions & MeSH terms

• Capsule Opacification
• Posterior Capsule Opacification

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Zhognshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in rate of posterior capsulotomy	Incidence rate of laser posterior capsulotomy	1 year, 2 year, 3 year, 4 year, 5 year after surgery
Secondary	change in visual acuity	Best corrected visual acuity tested with ETDRS chart	1 day, 1 week, 1 year post-op, and every year thereafter.
Secondary	change in objective scattering index	objective scattering index of participants	1 day, 1 week, 1 year post-op, and every year thereafter.
Secondary	change in Strehl ratio	Strehl ratio of participants	1 day, 1 week, 1 year post-op, and every year thereafter.
Secondary	change in modulation transfer function cut off	Modulation transfer function cut off of participants	1 day, 1 week, 1 year post-op, and every year thereafter.
Secondary	area of posterior capsular opacification	posterior capsular opacification area percentage	1 year, 2 year, 3 year, 4 year, 5 year after surgery
Secondary	residual lens fibers	amount of residual lens fibers at the posterior lens capsule	the amount of residual lens fibers is to be measured for every participant using ocular image taken with surgical microscope at the end of the cataract surgery