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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective, Multicenter,Randomized Clinical Investigation of A Viscoelastic-free Method for Implantable Collamer Lens (ICL) Implantation to Treat High Myopia: A Pilot Study

Conditions
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Myopia

Intervention / Treatment
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* Device: viscoelastic-free implantation system
* Device: standard viscoelastic-assisted Implantation system


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: viscoelastic-free system<br>Eyes in this group will use viscoelastic-free implantation system during the surgery | Device: viscoelastic-free implantation system<br>* Viscoelastic-free implantation system use balanced salt solution irrigation during the implantation<br>|
| Active Comparator: viscoelastic-assisted system<br>Eyes in this group will utilize the standard viscoelastic-assisted Implantation system during the surgery | Device: standard viscoelastic-assisted Implantation system<br>* This method utilize the viscoelastic agent to fill and maintain the anterior chamber during the implantation<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phakic Intraocular Lenses, viscoelastic