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

Myopia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03059043
• Other study ID #: 20170121
• Status: Recruiting
• Phase: N/A
• Start date: November 16, 2018
• Est. completion date: June 22, 2024

Study information

• Verified date: April 2023
• Source: Wenzhou Medical University
• Contact: AYong Yu, MD. PhD.
• Phone: +86-0577-88068880
• Email: yaybetter[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 22, 2024
• Est. primary completion date: June 22, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• viscoelastic-free implantation system
Viscoelastic-free implantation system use balanced salt solution irrigation during the implantation
• standard viscoelastic-assisted Implantation system
This method utilize the viscoelastic agent to fill and maintain the anterior chamber during the implantation

Locations

Country	Name	City	State
China	Hunan Provincial People's Hospital	Changsha	Hunan
China	Guangdong General Hospital	Guangzhou	Guangdong
China	Peking Union Medical College Hospital	Peking
China	Shanghai Ninth People's Hospital	Shanghai
China	The Eye Hispital of Wenzhou Medical University	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early Post-operative Intraocular Pressure	Intraocular Pressure measured by non-contact tonometers	2 hours after surgery
Secondary	Corrected Visual Acuity (UCVA) at Distance	Subjective refraction	baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery
Secondary	Uncorrected Visual Acuity (UCVA) at Distance	Measure by visual acuity chart	baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery
Secondary	Endothelial Cell Density	Measure by Specular Microscope	baseline, 1 month, 3 months and 6 months after surgery
Secondary	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
Secondary	Intraocular Pressure	Intraocular Pressure measured by non-contact tonometers	baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery
Secondary	Refractive error (by Phoropter)	subjective refraction by Phoropter	baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery
Secondary	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
Secondary	Duration of operation	Time from the first incision is made to the end of the surgery	at the time of the surgery
Secondary	Complications of ICL implantation	Lens opacities, Cataract surgery, Pupillary block, Ocular hypertension or glaucoma	up to 6 months after surgery