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

Not Applicable

• Conditions: Posterior Capsule Opacification

• Registration Number: NCT03605160
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-07-06
• Study First Submitted QC: 2018-07-21
• Study First Posted: 2018-07-30
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-26
• Last Update Posted: 2019-05-29
• Primary Completion: 2023-01-01
• Study Completion: 2023-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 740

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
change in rate of posterior capsulotomy	1 year, 2 year, 3 year, 4 year, 5 year after surgery	Incidence rate of laser posterior capsulotomy

Secondary Outcome Measures

Name	Time	Method
area of posterior capsular opacification	1 year, 2 year, 3 year, 4 year, 5 year after surgery	posterior capsular opacification area percentage
change in objective scattering index	1 day, 1 week, 1 year post-op, and every year thereafter.	objective scattering index of participants
change in visual acuity	1 day, 1 week, 1 year post-op, and every year thereafter.	Best corrected visual acuity tested with ETDRS chart
change in Strehl ratio	1 day, 1 week, 1 year post-op, and every year thereafter.	Strehl ratio of participants
change in modulation transfer function cut off	1 day, 1 week, 1 year post-op, and every year thereafter.	Modulation transfer function cut off of participants
residual lens fibers	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	amount of residual lens fibers at the posterior lens capsule

Trial Locations

Locations (1)

Zhognshan Ophthalmic Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China