MyopiaNCT03059043
Safety and Efficacy Study of A Viscoelastic-free Method for Implantable Collamer Lens (ICL) Implantation
A study testing viscoelastic-free implantation system and standard viscoelastic-assisted Implantation system in people with Myopia, run by Wenzhou Medical University at 5 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- viscoelastic-free implantation system and standard viscoelastic-assisted Implantation system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesChina
- Study dates
- 16 Nov 2018to 22 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Anpeng Pan, MD.OD. contact
5 sites in 1 country
China5 sites, 5 recruiting
- Not yet recruiting
Peking Union Medical College Hospital
Beijing, 100000
Yan Luo, MD.
- Not yet recruiting
Hunan Provincial People's Hospital
Changsha, Hunan, 410000
Hua Wang, MD.
- Not yet recruiting
Guangdong General Hospital
Guangzhou, Guangdong, 510000
Jin Zeng, MD.
- Not yet recruiting
Shanghai Ninth People's Hospital
Shanghai, 200000
Jibo Zhou, MD.
- Recruiting
The Eye Hispital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Anpeng Pan, MD.OD., +86-577-88068809, pananpeng@126.com
Shuangqian Zhu, MD.
About this study
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
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.
Read the 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.
- Conditions
- Myopia
- Being tested
- viscoelastic-free implantation system, standard viscoelastic-assisted Implantation system
- Keywords
- Phakic Intraocular Lenses, viscoelastic
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
viscoelastic-free implantation systemDevice
Viscoelastic-free implantation system use balanced salt solution irrigation during the implantation
standard viscoelastic-assisted Implantation systemDevice
This method utilize the viscoelastic agent to fill and maintain the anterior chamber during the implantation
| Study group | Role | What they receive |
|---|---|---|
| viscoelastic-free system | Experimental | Eyes in this group will use viscoelastic-free implantation system during the surgery Receives: Device: viscoelastic-free implantation system |
| viscoelastic-assisted system | Active comparator | Eyes in this group will utilize the standard viscoelastic-assisted Implantation system during the surgery Receives: Device: standard viscoelastic-assisted Implantation system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Post-operative Intraocular Pressure
Intraocular Pressure measured by non-contact tonometers
Measured: 2 hours after surgery
Secondary outcomes (9)
Corrected Visual Acuity (UCVA) at Distance
Subjective refraction
Measured: baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery
Uncorrected Visual Acuity (UCVA) at Distance
Measure by visual acuity chart
Measured: baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery
Endothelial Cell Density
Measure by Specular Microscope
Measured: baseline, 1 month, 3 months and 6 months after surgery
Vault measured by anterior segment OCT
Vault measured by anterior segment OCT
Measured: 2 hours, 1 day, 1 week, 1 month, 3 months and 6 months after surgery
Intraocular Pressure
Intraocular Pressure measured by non-contact tonometers
Measured: baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery
Refractive error (by Phoropter)
subjective refraction by Phoropter
Measured: baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery
Anterior chamber reaction (by a laser flare meter)
anterior chamber flare value was examined by a laser flare meter
Measured: baseline, 2 hours, 1 day, 1 week after surgery
Duration of operation
Time from the first incision is made to the end of the surgery
Measured: at the time of the surgery
Complications of ICL implantation
Lens opacities, Cataract surgery, Pupillary block, Ocular hypertension or glaucoma
Measured: up to 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start16 Nov 2018
- Primary completion22 Jun 2028 (estimated)
- Study completion22 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A-Yong Yu, Wenzhou Medical University
- Investigators
- AYong Yu, MD. PhD., Principal investigator, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03059043
- Sponsor's protocol ID
- 20170121
- Status last verified
- Aug 2026
- First submitted
- 13 Feb 2017
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03059043
- Acronym / sponsor ID
- 20170121
- Conditions
- Myopia
- Keywords
- Phakic Intraocular Lenses, viscoelastic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 16 Nov 2018 (actual)
- Primary completion
- 22 Jun 2028 (estimated)
- Study completion
- 22 Jun 2028 (estimated)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| viscoelastic-free system | Experimental | Device: viscoelastic-free implantation systemEyes in this group will use viscoelastic-free implantation system during the surgery |
| viscoelastic-assisted system | Active comparator | Device: standard viscoelastic-assisted Implantation systemEyes in this group will utilize the standard viscoelastic-assisted Implantation system during the surgery |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| viscoelastic-free implantation systemViscoelastic-free implantation system use balanced salt solution irrigation during the implantation | Device | viscoelastic-free system |
| standard viscoelastic-assisted Implantation systemThis method utilize the viscoelastic agent to fill and maintain the anterior chamber during the implantation | Device | viscoelastic-assisted system |
Primary outcome
Early Post-operative Intraocular Pressure
Time frame: 2 hours after surgery
Intraocular Pressure measured by non-contact tonometers
9 secondary outcomes
Corrected Visual Acuity (UCVA) at Distance
Time frame: baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery
Uncorrected Visual Acuity (UCVA) at Distance
Time frame: baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery
Endothelial Cell Density
Time frame: baseline, 1 month, 3 months and 6 months after surgery
Vault measured by anterior segment OCT
Time frame: 2 hours, 1 day, 1 week, 1 month, 3 months and 6 months after surgery
Intraocular Pressure
Time frame: baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery
Refractive error (by Phoropter)
Time frame: baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery
Anterior chamber reaction (by a laser flare meter)
Time frame: baseline, 2 hours, 1 day, 1 week after surgery
Duration of operation
Time frame: at the time of the surgery
Complications of ICL implantation
Time frame: up to 6 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anpeng Pan, MD.OD. contact
AYong Yu, MD. PhD. principal investigator
Wenzhou Medical University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing viscoelastic-free implantation system and standard viscoelastic-assisted Implantation system in people with Myopia, run by Wenzhou Medical University at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AYong Yu, MD. PhD. (+86-0577-88068880, yaybetter@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Post-operative Intraocular Pressure (time frame: 2 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.