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

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ClinicalTrials.gov Identifier: NCT03059043
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : May 9, 2018
Sponsor:
Information provided by (Responsible Party):
A-Yong Yu, Wenzhou Medical University

Brief Summary:
This study evaluates the safety and efficacy of a viscoelastic-free method for Implantable Collamer Lens(ICL) implantation to treat high myopia. Subjects were randomly assigned either to the new method group or to the control group which uses the standard method for implantation. The post-operative data are collected for analysis.

Condition or disease Intervention/treatment Phase
Myopia Device: viscoelastic-free implantation system Device: standard viscoelastic-assisted Implantation system Not Applicable

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 controlled trial 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 either viscoelastic-free method or standard method, and 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 : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Prospective, Multicenter,Randomized Clinical Investigation of A Viscoelastic-free Method for Implantable Collamer Lens (ICL) Implantation to Treat High Myopia: A Pilot Study
Estimated Study Start Date : July 1, 2018
Estimated Primary Completion Date : March 22, 2019
Estimated Study Completion Date : March 22, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: viscoelastic-free system
Subjects 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
Subjects 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




Primary Outcome Measures :
  1. Early Post-operative Intraocular Pressure [ Time Frame: 2 hours after surgery ]
    Intraocular Pressure measured by non-contact tonometers


Secondary Outcome Measures :
  1. Corrected Visual Acuity (UCVA) at Distance [ Time Frame: baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery ]
  2. Uncorrected Visual Acuity (UCVA) at Distance [ Time Frame: baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery ]
  3. Endothelial Cell Density [ Time Frame: baseline, 1 month, 3 months and 6 months after surgery ]
  4. 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

  5. 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

  6. Refractive error (by Phoropter) [ Time Frame: baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery ]
    subjective refraction by Phoropter

  7. 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

  8. Duration of operation [ Time Frame: at the time of the surgery ]
    Time from the first incision is made to the end of the surgery

  9. Complications of ICL implantation [ Time Frame: up to 6 months after surgery ]
    Lens opacities, Cataract surgery, Pupillary block, Ocular hypertension or glaucoma



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03059043


Contacts
Contact: AYong Yu, MD. PhD. +86-0577-88068880 yaybetter@hotmail.com
Contact: Anpeng Pan, MD.OD. pananpeng@126.com

Locations
China, Guangdong
Guangdong General Hospital Not yet recruiting
Guangzhou, Guangdong, China, 510000
Contact: Jin Zeng, MD.         
China, Hunan
Hunan Provincial People's Hospital Not yet recruiting
Changsha, Hunan, China, 410000
Contact: Hua Wang, MD.         
China, Zhejiang
The Eye Hispital of Wenzhou Medical University Recruiting
Wenzhou, Zhejiang, China, 325000
Contact: Anpeng Pan, MD.OD.    +86-577-88068809    pananpeng@126.com   
Sub-Investigator: Shuangqian Zhu, MD.         
Sub-Investigator: Kaijing Zhou, MD.PhD.         
China
Peking Union Medical College Hospital Not yet recruiting
Peking, China, 100000
Contact: Yan Luo, MD.         
Shanghai Ninth People's Hospital Not yet recruiting
Shanghai, China, 200000
Contact: Jibo Zhou, MD.         
Sponsors and Collaborators
Wenzhou Medical University
Investigators
Principal Investigator: AYong Yu, MD. PhD. Wenzhou Medical University

Responsible Party: A-Yong Yu, Director of the Cataract Clinical Center, Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT03059043     History of Changes
Other Study ID Numbers: 20170121
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by A-Yong Yu, Wenzhou Medical University:
Phakic Intraocular Lenses
viscoelastic

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases