NCT03059043

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Nov 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress98%
Nov 2018Jun 2026

First Submitted

Initial submission to the registry

February 13, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
1.7 years until next milestone

Study Start

First participant enrolled

November 16, 2018

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2026

Last Updated

July 23, 2024

Status Verified

July 1, 2024

Enrollment Period

7.6 years

First QC Date

February 13, 2017

Last Update Submit

July 22, 2024

Conditions

Myopia

Keywords

Phakic Intraocular Lensesviscoelastic

Outcome Measures

Primary Outcomes (1)

  • Early Post-operative Intraocular Pressure

    Intraocular Pressure measured by non-contact tonometers

    2 hours after surgery

Secondary Outcomes (9)

  • Corrected Visual Acuity (UCVA) at Distance

    baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery

  • Uncorrected Visual Acuity (UCVA) at Distance

    baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery

  • Endothelial Cell Density

    baseline, 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

    baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery

  • +4 more secondary outcomes

Study Arms (2)

viscoelastic-free system

EXPERIMENTAL

Eyes in this group will use viscoelastic-free implantation system during the surgery

Device: viscoelastic-free implantation system

viscoelastic-assisted system

ACTIVE COMPARATOR

Eyes in this group will utilize the standard viscoelastic-assisted Implantation system during the surgery

Device: standard viscoelastic-assisted Implantation system

Interventions

viscoelastic-free implantation systemDEVICE

Viscoelastic-free implantation system use balanced salt solution irrigation during the implantation

viscoelastic-free system
standard viscoelastic-assisted Implantation systemDEVICE

This method utilize the viscoelastic agent to fill and maintain the anterior chamber during the implantation

viscoelastic-assisted system

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • D 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Guangdong General Hospital

Guangzhou, Guangdong, 510000, China

NOT YET RECRUITING

Hunan Provincial People's Hospital

Changsha, Hunan, 410000, China

NOT YET RECRUITING

The Eye Hispital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

RECRUITING

Peking Union Medical College Hospital

Beijing, 100000, China

NOT YET RECRUITING

Shanghai Ninth People's Hospital

Shanghai, 200000, China

NOT YET RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • AYong Yu, MD. PhD.

    Wenzhou Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

AYong Yu, MD. PhD.

CONTACT

+86-0577-88068880yaybetter@hotmail.com

Anpeng Pan, MD.OD.

CONTACT

pananpeng@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Cataract Clinical Center

Study Record Dates

First Submitted

February 13, 2017

First Posted

February 23, 2017

Study Start

November 16, 2018

Primary Completion (Estimated)

June 22, 2026

Study Completion (Estimated)

June 22, 2026

Last Updated

July 23, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(5)