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

Wenzhou Medical University

Status: Enrolling

Conditions: Myopia

Treatments: Device: standard viscoelastic-assisted Implantation system; Device: viscoelastic-free implantation system

Study type: Interventional

Funder types: Other

Identifiers

NCT03059043

20170121

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

---

60 participants in 2 patient groups

viscoelastic-free system

Experimental group

Description:

Eyes in this group will use viscoelastic-free implantation system during the surgery

Treatment:

Device: viscoelastic-free implantation system

viscoelastic-assisted system

Active Comparator group

Description:

Eyes in this group will utilize the standard viscoelastic-assisted Implantation system during the surgery

Treatment:

Device: standard viscoelastic-assisted Implantation system