- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510060
- Zhognshan Ophthalmic Center, Sun Yat-sen University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: traditional group
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.
|
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.
|
Experimental: fluid-jet group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in rate of posterior capsulotomy
Time Frame: 1 year, 2 year, 3 year, 4 year, 5 year after surgery
|
Incidence rate of laser posterior capsulotomy
|
1 year, 2 year, 3 year, 4 year, 5 year after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in visual acuity
Time Frame: 1 day, 1 week, 1 year post-op, and every year thereafter.
|
Best corrected visual acuity tested with ETDRS chart
|
1 day, 1 week, 1 year post-op, and every year thereafter.
|
change in objective scattering index
Time Frame: 1 day, 1 week, 1 year post-op, and every year thereafter.
|
objective scattering index of participants
|
1 day, 1 week, 1 year post-op, and every year thereafter.
|
change in Strehl ratio
Time Frame: 1 day, 1 week, 1 year post-op, and every year thereafter.
|
Strehl ratio of participants
|
1 day, 1 week, 1 year post-op, and every year thereafter.
|
change in modulation transfer function cut off
Time Frame: 1 day, 1 week, 1 year post-op, and every year thereafter.
|
Modulation transfer function cut off of participants
|
1 day, 1 week, 1 year post-op, and every year thereafter.
|
area of posterior capsular opacification
Time Frame: 1 year, 2 year, 3 year, 4 year, 5 year after surgery
|
posterior capsular opacification area percentage
|
1 year, 2 year, 3 year, 4 year, 5 year after surgery
|
residual lens fibers
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
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Yizhi Liu, M.D., Ph.D., Zhongshan Ophthalmic Center, Sun Yat-sen University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCPMOH2018-China-5
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Posterior Capsule Opacification
-
Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUnknownCataract | Posterior Capsule OpacificationChina
-
Hanita LensesRecruitingPosterior Capsule OpacificationIsrael
-
Sohag UniversityRecruitingPosterior Capsule OpacificationEgypt
-
Prim. Prof. Dr. Oliver Findl, MBAUnknownPosterior Capsule OpacificationAustria
-
Minia UniversityCompletedPosterior Capsule OpacificationSaudi Arabia
-
Sun Yat-sen UniversityUnknownCataract | Posterior Capsule OpacificationChina
-
Medical University of ViennaCompletedCataract | Posterior Capsule OpacificationAustria
-
Prim. Prof. Dr. Oliver Findl, MBAUnknown
-
Medical University of ViennaCompletedPosterior Capsule Opacification
-
University of Sao PauloCompletedPosterior Capsule OpacificationBrazil
Clinical Trials on traditional polish
-
University of Alabama at BirminghamCompletedEvaluation of Jublia on Nail Polish With Healthy ToenailsUnited States
-
Geisinger ClinicCompleted
-
Antalya Training and Research HospitalCompleted
-
Pomeranian Medical University SzczecinCompleted
-
University of MichiganEnrolling by invitationPeri-implant MucositisUnited States
-
Poznan University of Medical SciencesCompletedInfant DevelopmentPoland
-
Tarsus UniversityMustafa Kemal University; Mersin University; Necmettin Erbakan UniversityRecruitingPerioperative Care | Healthy Individuals | Oxygen Saturation | Nursing | Shellac Nail PolishTurkey
-
University of North Carolina, Chapel HillCompletedBacterial Infections | Surgical Site Infection | Contaminated Medical or Biological SubstancesUnited States
-
NHS Greater Glasgow and ClydeUnknownBreast Cancer | Nail ToxicityUnited Kingdom
-
Medical University of LodzCompleted