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

NCT03605160 | Unknown DMC

• 1 other identifier: CCPMOH2018-China-5
• Study Type: interventional
• Target: 740
• Locations: 1 country
• Sites: 1

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.

Conditions

Posterior Capsule Opacification

Keywords

cataract surgery; polish; residual lens fibers; fluid-jet

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• change in visual acuity

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

• change in objective scattering index

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

• change in Strehl ratio

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

• change in modulation transfer function cut off

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

• area of posterior capsular opacification

  1 year, 2 year, 3 year, 4 year, 5 year after surgery

Study Arms (2)

traditional group

ACTIVE COMPARATOR

Perform conventional continuous curvilinear capsulorhexis. 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. All operations are videotaped during the whole operation. The total polish time is recorded as the time of all polish procedures.

Procedure: traditional polish

fluid-jet group

EXPERIMENTAL

Perform conventional continuous curvilinear capsulorhexis. 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. All operations are videotaped during the whole operation. The total time of all jet procedures recorded in the videotape is the total time of jet.

Procedure: fluid-jet

Interventions

traditional polish PROCEDURE

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.

traditional group

fluid-jet PROCEDURE

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.

fluid-jet group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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.

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Zhognshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Study Officials

• Yizhi Liu, M.D., Ph.D.

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 6, 2018
• First Posted: July 30, 2018
• Study Start: January 1, 2018
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: May 29, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)