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

Sun Yat-sen University740 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

740

Conditions

Posterior Capsule Opacification

Interventions

traditional polishPROCEDURE

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-jetPROCEDURE

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.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Zhognshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

change in rate of posterior capsulotomy

Incidence rate of laser posterior capsulotomy

Time frame: 1 year, 2 year, 3 year, 4 year, 5 year after surgery

Secondary Outcomes

change in visual acuity

Best corrected visual acuity tested with ETDRS chart

Time frame: 1 day, 1 week, 1 year post-op, and every year thereafter.

change in objective scattering index

objective scattering index of participants

Time frame: 1 day, 1 week, 1 year post-op, and every year thereafter.

change in Strehl ratio

Strehl ratio of participants

Time frame: 1 day, 1 week, 1 year post-op, and every year thereafter.

change in modulation transfer function cut off

Modulation transfer function cut off of participants

Time frame: 1 day, 1 week, 1 year post-op, and every year thereafter.

area of posterior capsular opacification

posterior capsular opacification area percentage

Time frame: 1 year, 2 year, 3 year, 4 year, 5 year after surgery

residual lens fibers

amount of residual lens fibers at the posterior lens capsule

Time frame: 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

Data from ClinicalTrials.gov

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