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

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: Recruiting
• Conditions: Myopia
• Intervention / Treatment: Device: viscoelastic-free implantation system; Device: standard viscoelastic-assisted Implantation system

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: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anpeng Pan, MD.OD.; Email: pananpeng@126.com
• Study Contact Backup: Name: AYong Yu, MD. PhD.; Phone Number: +86-0577-88068880; Email: yaybetter@hotmail.com

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: Anpeng Pan, MD.OD.; Phone Number: +86-577-88068809; Email: pananpeng@126.com
      • Sub-Investigator: Shuangqian Zhu, MD.
      • Sub-Investigator: Kaijing Zhou, MD.PhD.

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Early Post-operative Intraocular Pressure	Intraocular Pressure measured by non-contact tonometers	2 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corrected Visual Acuity (UCVA) at Distance	Subjective refraction	baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery
Uncorrected Visual Acuity (UCVA) at Distance	Measure by visual acuity chart	baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery
Endothelial Cell Density	Measure by Specular Microscope	baseline, 1 month, 3 months and 6 months after surgery
Vault measured by anterior segment OCT	Vault measured by anterior segment OCT	2 hours, 1 day, 1 week, 1 month, 3 months and 6 months after surgery
Intraocular Pressure	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)	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)	anterior chamber flare value was examined by a laser flare meter	baseline, 2 hours, 1 day, 1 week after surgery
Duration of operation	Time from the first incision is made to the end of the surgery	at the time of the surgery
Complications of ICL implantation	Lens opacities, Cataract surgery, Pupillary block, Ocular hypertension or glaucoma	up to 6 months after surgery

Collaborators and Investigators

• Sponsor: Wenzhou Medical University
• Investigators: Principal Investigator: AYong Yu, MD. PhD., Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2018
• Primary Completion (Estimated): June 22, 2026
• Study Completion (Estimated): June 22, 2026

Study Registration Dates

• First Submitted: February 13, 2017
• First Submitted That Met QC Criteria: February 20, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): July 23, 2024
• Last Update Submitted That Met QC Criteria: July 22, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Phakic Intraocular Lenses; viscoelastic
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID 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