Safety and Efficacy Study of A Viscoelastic-free Method for Implantable Collamer Lens (ICL) Implantation
NCT ID: NCT03059043
Last Updated: 2024-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2018-11-16
2026-06-22
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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viscoelastic-free system
Eyes in this group will use viscoelastic-free implantation system during the surgery
viscoelastic-free implantation system
Viscoelastic-free implantation system use balanced salt solution irrigation during the implantation
viscoelastic-assisted system
Eyes in this group will utilize the standard viscoelastic-assisted Implantation system during the surgery
standard viscoelastic-assisted Implantation system
This method utilize the viscoelastic agent to fill and maintain the anterior chamber during the implantation
Interventions
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viscoelastic-free implantation system
Viscoelastic-free implantation system use balanced salt solution irrigation during the implantation
standard viscoelastic-assisted Implantation system
This method utilize the viscoelastic agent to fill and maintain the anterior chamber during the implantation
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
45 Years
ALL
Yes
Sponsors
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Wenzhou Medical University
OTHER
Responsible Party
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A-Yong Yu
Director of the Cataract Clinical Center
Principal Investigators
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AYong Yu, MD. PhD.
Role: PRINCIPAL_INVESTIGATOR
Wenzhou Medical University
Locations
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Guangdong General Hospital
Guangzhou, Guangdong, China
Hunan Provincial People's Hospital
Changsha, Hunan, China
The Eye Hispital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Peking Union Medical College Hospital
Beijing, , China
Shanghai Ninth People's Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Jin Zeng, MD.
Role: primary
Hua Wang, MD.
Role: primary
Yan Luo, MD.
Role: primary
Jibo Zhou, MD.
Role: primary
Other Identifiers
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20170121
Identifier Type: -
Identifier Source: org_study_id
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