An interventional study of viscoelastic-free implantation system and standard viscoelastic-assisted Implantation system in Myopia, sponsored by Wenzhou Medical University. Recruiting at 5 sites in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Wenzhou Medical University · Not applicable, Interventional, and Treatment
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.
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.
1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.
This study's planned enrollment of 60 is below the median of 78 across 923 interventional studies indexed under Myopia.
Browse Myopia studies →Wenzhou Medical University is the lead sponsor of 94 studies on the registry; 8 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Eyes in this group will use viscoelastic-free implantation system during the surgery
Device: viscoelastic-free implantation system
Eyes in this group will utilize the standard viscoelastic-assisted Implantation system during the surgery
Device: standard viscoelastic-assisted Implantation system
Viscoelastic-free implantation system use balanced salt solution irrigation during the implantation
This method utilize the viscoelastic agent to fill and maintain the anterior chamber during the implantation
Early Post-operative Intraocular Pressure
Intraocular Pressure measured by non-contact tonometers
Time frame: 2 hours after surgery
Corrected Visual Acuity (UCVA) at Distance
Subjective refraction
Time frame: 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
Time frame: baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery
Endothelial Cell Density
Measure by Specular Microscope
Time frame: baseline, 1 month, 3 months and 6 months after surgery
Vault measured by anterior segment OCT
Vault measured by anterior segment OCT
Time frame: 2 hours, 1 day, 1 week, 1 month, 3 months and 6 months after surgery
Intraocular Pressure
Intraocular Pressure measured by non-contact tonometers
Time frame: baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery
Refractive error (by Phoropter)
subjective refraction by Phoropter
Time frame: 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
Time frame: 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
Time frame: at the time of the surgery
Complications of ICL implantation
Lens opacities, Cataract surgery, Pupillary block, Ocular hypertension or glaucoma
Time frame: up to 6 months after surgery
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2018 (actual). Primary completion is estimated for Jun 2028, 115 months after the start.
Of 200 non-industry interventional studies with no phase under Myopia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 115 months is above that.
Counting every sponsor, half of 434 studies reached it within 14 months; a quarter within 3 and three quarters within 34.
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Wenzhou Medical University