Safety and Efficacy Study of A Viscoelastic-free Method for Implantable Collamer Lens (ICL) Implantation

July 22, 2024 updated by: A-Yong Yu, Wenzhou Medical University

Prospective, Multicenter,Randomized Clinical Investigation of A Viscoelastic-free Method for Implantable Collamer Lens (ICL) Implantation to Treat High Myopia: A Pilot Study

This study evaluates the safety and efficacy of a viscoelastic-free method for Implantable Collamer Lens(ICL) implantation to treat high myopia. The subjects undergo randomization of ICL implantation using the viscoelastic-free method on one eye and undergoing standard method on the other one. The post-operative data are collected for analysis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Implantable Collamer Lens(ICL) implantation has been proved to be an effective refractive option for surgical correction of high myopia. Currently, standard method utilizing the viscoelastic agent to fill and maintain the anterior chamber during the implantation, this requires an additional step to remove the viscoelastic agent at the end of the surgery and may cause the intraocular pressure spike in the early post-operative phase due to the incomplete removal of the viscoelastics. The new method is viscoelastic-free, which can be achieved by using balanced salt solution irrigation during the implantation.

This study is a prospective, randomized, paired-eye study to compare the safety and efficacy of the viscoelastic-free method with the standard method. Subjects enrolled in the study will be randomized to receive viscoelastic-free method on one eye and undergo standard method on the other one.The clinical outcomes of two groups will be assessed at several follow-ups: 2 hours, 1 day, 1 week, 1 month, 3 months and 6 months post-operatively.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
      • Peking, China, 100000
        • Not yet recruiting
        • Peking Union Medical College Hospital
        • Contact:
          • Yan Luo, MD.
      • Shanghai, China, 200000
        • Not yet recruiting
        • Shanghai Ninth People's Hospital
        • Contact:
          • Jibo Zhou, MD.
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Not yet recruiting
        • Guangdong General Hospital
        • Contact:
          • Jin Zeng, MD.
    • Hunan
      • Changsha, Hunan, China, 410000
        • Not yet recruiting
        • Hunan Provincial People's Hospital
        • Contact:
          • Hua Wang, MD.
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • Recruiting
        • The Eye Hispital of Wenzhou Medical University
        • Contact:
        • Sub-Investigator:
          • Shuangqian Zhu, MD.
        • Sub-Investigator:
          • Kaijing Zhou, MD.PhD.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 41 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Documented stable refraction for at least 1 year(within 0.5D)
  • Best spectacle-corrected visual acuity (BCVA) of 20/40 or better
  • Clear central cornea
  • -0.5D to -18.0D of myopic refractive error
  • Normal anterior chamber depth at least 2.8 mm to endothelium
  • Endothelial cell density (ECD) more than 2000 cell/mm2
  • Pupil diameter smaller than 7.0 mm under mesopic condition
  • Discontinued 3 weeks for hard contact lens and 1 week for soft contact lens wear

Exclusion Criteria:

  • Preexisting ocular diseases or conditions other than myopia, evidence of progressive or acute ocular disease
  • Evidence of connective tissue disease or other systemic diseases that may confound the results of the study;
  • Narrow angle of anterior chamber
  • Pregnant, lactating, or planning to become pregnant during the course of the trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: viscoelastic-free system
Eyes in this group will use viscoelastic-free implantation system during the surgery
Device: viscoelastic-free implantation system
Viscoelastic-free implantation system use balanced salt solution irrigation during the implantation
Active Comparator: viscoelastic-assisted system
Eyes in this group will utilize the standard viscoelastic-assisted Implantation system during the surgery
Device: standard viscoelastic-assisted Implantation system
This method utilize the viscoelastic agent to fill and maintain the anterior chamber during the implantation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Early Post-operative Intraocular Pressure
Time Frame: 2 hours after surgery
Intraocular Pressure measured by non-contact tonometers
2 hours after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Corrected Visual Acuity (UCVA) at Distance
Time Frame: baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery
Subjective refraction
baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery
Uncorrected Visual Acuity (UCVA) at Distance
Time Frame: baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery
Measure by visual acuity chart
baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery
Endothelial Cell Density
Time Frame: baseline, 1 month, 3 months and 6 months after surgery
Measure by Specular Microscope
baseline, 1 month, 3 months and 6 months after surgery
Vault measured by anterior segment OCT
Time Frame: 2 hours, 1 day, 1 week, 1 month, 3 months and 6 months after surgery
Vault measured by anterior segment OCT
2 hours, 1 day, 1 week, 1 month, 3 months and 6 months after surgery
Intraocular Pressure
Time Frame: baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery
Intraocular Pressure measured by non-contact tonometers
baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery
Refractive error (by Phoropter)
Time Frame: baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery
subjective refraction by Phoropter
baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery
Anterior chamber reaction (by a laser flare meter)
Time Frame: baseline, 2 hours, 1 day, 1 week after surgery
anterior chamber flare value was examined by a laser flare meter
baseline, 2 hours, 1 day, 1 week after surgery
Duration of operation
Time Frame: at the time of the surgery
Time from the first incision is made to the end of the surgery
at the time of the surgery
Complications of ICL implantation
Time Frame: up to 6 months after surgery
Lens opacities, Cataract surgery, Pupillary block, Ocular hypertension or glaucoma
up to 6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wenzhou Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: AYong Yu, MD. PhD., Wenzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 16, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 22, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 22, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20170121

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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