Safety and Efficacy Study of A Viscoelastic-free Method for Implantable Collamer Lens (ICL) Implantation
- Conditions
- Myopia
- Interventions
- Device: viscoelastic-free implantation systemDevice: standard viscoelastic-assisted Implantation system
- Registration Number
- NCT03059043
- Lead Sponsor
- Wenzhou Medical University
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description viscoelastic-free system viscoelastic-free implantation system Eyes in this group will use viscoelastic-free implantation system during the surgery viscoelastic-assisted system standard viscoelastic-assisted Implantation system Eyes in this group will utilize the standard viscoelastic-assisted Implantation system during the surgery
- Primary Outcome Measures
Name Time Method Early Post-operative Intraocular Pressure 2 hours after surgery Intraocular Pressure measured by non-contact tonometers
- Secondary Outcome Measures
Name Time Method 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
Refractive error (by Phoropter) baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery subjective refraction by Phoropter
Duration of operation at the time of the surgery Time from the first incision is made to the end of the surgery
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
Intraocular Pressure baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery Intraocular Pressure measured by non-contact tonometers
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
Complications of ICL implantation up to 6 months after surgery Lens opacities, Cataract surgery, Pupillary block, Ocular hypertension or glaucoma
Endothelial Cell Density baseline, 1 month, 3 months and 6 months after surgery Measure by Specular Microscope
Trial Locations
- Locations (5)
Hunan Provincial People's Hospital
🇨🇳Changsha, Hunan, China
Guangdong General Hospital
🇨🇳Guangzhou, Guangdong, China
Peking Union Medical College Hospital
🇨🇳Peking, China
The Eye Hispital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China
Shanghai Ninth People's Hospital
🇨🇳Shanghai, China