Clinical trial NCT03059043: Safety and Efficacy Study of A Viscoelastic-free Method for Implantable Collamer Lens (ICL) Implantation
Official title: Prospective, Multicenter,Randomized Clinical Investigation of A Viscoelastic-free Method for Implantable Collamer Lens (ICL) Implantation to Treat High Myopia: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myopia
Keywords: Phakic Intraocular Lenses
viscoelastic
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Early Post-operative Intraocular Pressure
timeFrame: 2 hours after surgery
Secondary outcomes:
measure: Corrected Visual Acuity (UCVA) at Distance
timeFrame: baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery
measure: Uncorrected Visual Acuity (UCVA) at Distance
timeFrame: baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery
measure: Endothelial Cell Density
timeFrame: baseline, 1 month, 3 months and 6 months after surgery
measure: Vault measured by anterior segment OCT
timeFrame: 2 hours, 1 day, 1 week, 1 month, 3 months and 6 months after surgery
measure: Intraocular Pressure
timeFrame: baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery
measure: Refractive error (by Phoropter)
timeFrame: baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery
measure: Anterior chamber reaction (by a laser flare meter)
timeFrame: baseline, 2 hours, 1 day, 1 week after surgery
measure: Duration of operation
timeFrame: at the time of the surgery
measure: Complications of ICL implantation
timeFrame: up to 6 months after surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
city: Changsha
country: China
facility: Hunan Provincial People's Hospital
state: Hunan
city: Wenzhou
country: China
facility: The Eye Hispital of Wenzhou Medical University
state: Zhejiang
city: Peking
country: China
facility: Peking Union Medical College Hospital
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital
Study officials:
affiliation: Wenzhou Medical University
name: AYong Yu, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References: