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

Primary Purpose

Myopia

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
viscoelastic-free implantation system
standard viscoelastic-assisted Implantation system
Sponsored by
Wenzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia focused on measuring Phakic Intraocular Lenses, viscoelastic

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Guangdong General Hospital
  • Hunan Provincial People's Hospital
  • The Eye Hispital of Wenzhou Medical UniversityRecruiting
  • Peking Union Medical College Hospital
  • Shanghai Ninth People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

viscoelastic-free system

viscoelastic-assisted system

Arm Description

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

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

Outcomes

Primary Outcome Measures

Early Post-operative Intraocular Pressure
Intraocular Pressure measured by non-contact tonometers

Secondary Outcome Measures

Corrected Visual Acuity (UCVA) at Distance
Subjective refraction
Uncorrected Visual Acuity (UCVA) at Distance
Measure by visual acuity chart
Endothelial Cell Density
Measure by Specular Microscope
Vault measured by anterior segment OCT
Vault measured by anterior segment OCT
Intraocular Pressure
Intraocular Pressure measured by non-contact tonometers
Refractive error (by Phoropter)
subjective refraction by Phoropter
Anterior chamber reaction (by a laser flare meter)
anterior chamber flare value was examined by a laser flare meter
Duration of operation
Time from the first incision is made to the end of the surgery
Complications of ICL implantation
Lens opacities, Cataract surgery, Pupillary block, Ocular hypertension or glaucoma

Full Information

First Posted
February 13, 2017
Last Updated
April 27, 2023
Sponsor
Wenzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03059043
Brief Title
Safety and Efficacy Study of A Viscoelastic-free Method for Implantable Collamer Lens (ICL) Implantation
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 16, 2018 (Actual)
Primary Completion Date
June 22, 2024 (Anticipated)
Study Completion Date
June 22, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wenzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
Phakic Intraocular Lenses, viscoelastic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
viscoelastic-free system
Arm Type
Experimental
Arm Description
Eyes in this group will use viscoelastic-free implantation system during the surgery
Arm Title
viscoelastic-assisted system
Arm Type
Active Comparator
Arm Description
Eyes in this group will utilize the standard viscoelastic-assisted Implantation system during the surgery
Intervention Type
Device
Intervention Name(s)
viscoelastic-free implantation system
Intervention Description
Viscoelastic-free implantation system use balanced salt solution irrigation during the implantation
Intervention Type
Device
Intervention Name(s)
standard viscoelastic-assisted Implantation system
Intervention Description
This method utilize the viscoelastic agent to fill and maintain the anterior chamber during the implantation
Primary Outcome Measure Information:
Title
Early Post-operative Intraocular Pressure
Description
Intraocular Pressure measured by non-contact tonometers
Time Frame
2 hours after surgery
Secondary Outcome Measure Information:
Title
Corrected Visual Acuity (UCVA) at Distance
Description
Subjective refraction
Time Frame
baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery
Title
Uncorrected Visual Acuity (UCVA) at Distance
Description
Measure by visual acuity chart
Time Frame
baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery
Title
Endothelial Cell Density
Description
Measure by Specular Microscope
Time Frame
baseline, 1 month, 3 months and 6 months after surgery
Title
Vault measured by anterior segment OCT
Description
Vault measured by anterior segment OCT
Time Frame
2 hours, 1 day, 1 week, 1 month, 3 months and 6 months after surgery
Title
Intraocular Pressure
Description
Intraocular Pressure measured by non-contact tonometers
Time Frame
baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery
Title
Refractive error (by Phoropter)
Description
subjective refraction by Phoropter
Time Frame
baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery
Title
Anterior chamber reaction (by a laser flare meter)
Description
anterior chamber flare value was examined by a laser flare meter
Time Frame
baseline, 2 hours, 1 day, 1 week after surgery
Title
Duration of operation
Description
Time from the first incision is made to the end of the surgery
Time Frame
at the time of the surgery
Title
Complications of ICL implantation
Description
Lens opacities, Cataract surgery, Pupillary block, Ocular hypertension or glaucoma
Time Frame
up to 6 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AYong Yu, MD. PhD.
Phone
+86-0577-88068880
Email
yaybetter@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Anpeng Pan, MD.OD.
Email
pananpeng@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AYong Yu, MD. PhD.
Organizational Affiliation
Wenzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Zeng, MD.
Facility Name
Hunan Provincial People's Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hua Wang, MD.
Facility Name
The Eye Hispital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anpeng Pan, MD.OD.
Phone
+86-577-88068809
Email
pananpeng@126.com
First Name & Middle Initial & Last Name & Degree
Shuangqian Zhu, MD.
First Name & Middle Initial & Last Name & Degree
Kaijing Zhou, MD.PhD.
Facility Name
Peking Union Medical College Hospital
City
Peking
ZIP/Postal Code
100000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Luo, MD.
Facility Name
Shanghai Ninth People's Hospital
City
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jibo Zhou, MD.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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