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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| viscoelastic-free system | Experimental | Eyes in this group will use viscoelastic-free implantation system during the surgery |
|
| viscoelastic-assisted system | Active Comparator | Eyes in this group will utilize the standard viscoelastic-assisted Implantation system during the surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| viscoelastic-free implantation system | Device | Viscoelastic-free implantation system use balanced salt solution irrigation during the implantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Early Post-operative Intraocular Pressure | Intraocular Pressure measured by non-contact tonometers | 2 hours after surgery |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AYong Yu, MD. PhD. | Contact | +86-0577-88068880 | yaybetter@hotmail.com | |
| Anpeng Pan, MD.OD. | Contact | pananpeng@126.com |
| Name | Affiliation | Role |
|---|---|---|
| AYong Yu, MD. PhD. | Wenzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong General Hospital | Not yet recruiting | Guangzhou | Guangdong | 510000 | China |
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| standard viscoelastic-assisted Implantation system | Device | This method utilize the viscoelastic agent to fill and maintain the anterior chamber during the implantation |
|
| 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 |
| Hunan Provincial People's Hospital | Not yet recruiting | Changsha | Hunan | 410000 | China |
|
| The Eye Hispital of Wenzhou Medical University | Recruiting | Wenzhou | Zhejiang | 325000 | China |
|
| Peking Union Medical College Hospital | Not yet recruiting | Beijing | 100000 | China |
|
| Shanghai Ninth People's Hospital | Not yet recruiting | Shanghai | 200000 | China |
|
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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