Safety and Efficacy Study of A Viscoelastic-free Method for Implantable Collamer Lens (ICL) Implantation
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: viscoelastic-free system Eyes in this group will use viscoelastic-free implantation system during the surgery |
Device: viscoelastic-free implantation system
Viscoelastic-free implantation system use balanced salt solution irrigation during the implantation
|
| Active Comparator: viscoelastic-assisted system Eyes in this group will utilize the standard viscoelastic-assisted Implantation system during the surgery |
Device: standard viscoelastic-assisted Implantation system
This method utilize the viscoelastic agent to fill and maintain the anterior chamber during the implantation
|
Outcome Measures
Primary Outcome Measures
- Early Post-operative Intraocular Pressure [2 hours after surgery]
Intraocular Pressure measured by non-contact tonometers
Secondary Outcome Measures
- Corrected Visual Acuity (UCVA) at Distance [baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery]
Subjective refraction
- Uncorrected Visual Acuity (UCVA) at Distance [baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery]
Measure by visual acuity chart
- Endothelial Cell Density [baseline, 1 month, 3 months and 6 months after surgery]
Measure by Specular Microscope
- Vault measured by anterior segment OCT [2 hours, 1 day, 1 week, 1 month, 3 months and 6 months after surgery]
Vault measured by anterior segment OCT
- Intraocular Pressure [baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery]
Intraocular Pressure measured by non-contact tonometers
- Refractive error (by Phoropter) [baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery]
subjective refraction by Phoropter
- Anterior chamber reaction (by a laser flare meter) [baseline, 2 hours, 1 day, 1 week after surgery]
anterior chamber flare value was examined by a laser flare meter
- Duration of operation [at the time of the surgery]
Time from the first incision is made to the end of the surgery
- Complications of ICL implantation [up to 6 months after surgery]
Lens opacities, Cataract surgery, Pupillary block, Ocular hypertension or glaucoma
Eligibility Criteria
Criteria
Inclusion Criteria:
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Documented stable refraction for at least 1 year(within 0.5D)
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Best spectacle-corrected visual acuity (BCVA) of 20/40 or better
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Clear central cornea
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-0.5D to -18.0D of myopic refractive error
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Normal anterior chamber depth at least 2.8 mm to endothelium
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Endothelial cell density (ECD) more than 2000 cell/mm2
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Pupil diameter smaller than 7.0 mm under mesopic condition
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Discontinued 3 weeks for hard contact lens and 1 week for soft contact lens wear
Exclusion Criteria:
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Preexisting ocular diseases or conditions other than myopia, evidence of progressive or acute ocular disease
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Evidence of connective tissue disease or other systemic diseases that may confound the results of the study;
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Narrow angle of anterior chamber
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Pregnant, lactating, or planning to become pregnant during the course of the trial
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Guangdong General Hospital | Guangzhou | Guangdong | China | 510000 |
| 2 | Hunan Provincial People's Hospital | Changsha | Hunan | China | 410000 |
| 3 | The Eye Hispital of Wenzhou Medical University | Wenzhou | Zhejiang | China | 325000 |
| 4 | Peking Union Medical College Hospital | Peking | China | 100000 | |
| 5 | Shanghai Ninth People's Hospital | Shanghai | China | 200000 |
Sponsors and Collaborators
- Wenzhou Medical University
Investigators
- Principal Investigator: AYong Yu, MD. PhD., Wenzhou Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20170121