High MyopiaNCT06966622
Comparison of Retinal Damage in ICL Implantation Using 3D Visualization System vs. Microscope
A study testing 3D visualization system with coaxial illumination and microscope with standard illumination in people with High Myopia, run by Fuzhou Eye Hospital.
Trial summary
Implantable collamer lens (ICL) implantation is considered one of the most effective surgical treatments for high myopia. The procedure primarily involves adjusting the position of the ICL within the eye. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- High Myopia
- What is being tested?
- 3D visualization system with coaxial illumination and microscope with standard illumination
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 25 Aug 2025to 31 May 2026
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of high myopic
- Aged 18-40 years
- Desire to improve their refractive status via ICL surgery
- Relatively stable refractive error (change ≤ 0.50 D per year for two consecutive years)
- Central anterior chamber depth ≥ 2.8 mm
- Open angles
- Corneal endothelial cell density ≥ 2000 cells/mm2.
Who cannot join
- Cataracts
- Corneal diseases,
- Glaucoma,
- Nystagmus,
- Strabismus,
- Lens subluxation,
Show all 10Show fewer
- Severe vitreoretinal diseases,
- Other ocular diseases
- A history of ocular trauma
- A history of ocular surgery
About this study
Official title: Comparison of Ngenuity and Traditional Microscopy in Assessing Retinal Function Recovery Post-ICL Surgery
Implantable collamer lens (ICL) implantation is considered one of the most effective surgical treatments for high myopia. The procedure primarily involves adjusting the position of the ICL within the eye. However, precise calculation of the ICL optical power may cause the surgical light source to remain focused on the macular area during this process, potentially leading to iatrogenic light-induced damage. Theoretically, the combination of a 3D visualization surgical system and coaxial illumination technology can reduce the illumination intensity and decrease iatrogenic light damage. This study aims to compare the retinal physiological changes in patients undergoing ICL surgery through 3D visualization surgical system with coaxial illumination versus a traditional microscope with standard illumination.
- Conditions
- High Myopia
- Being tested
- 3D visualization system with coaxial illumination, microscope with standard illumination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D visualization system with coaxial illuminationProcedure or surgery
operation through 3D visualization system with coaxial illumination
microscope with standard illuminationProcedure or surgery
operation through microscope with standard illumination
| Study group | Role | What they receive |
|---|---|---|
| 3D visualization system | Experimental | Not described Receives: Procedure: 3D visualization system with coaxial illumination |
| Microscope | Active comparator | Not described Receives: Procedure: microscope with standard illumination |
What is being measured
The primary outcome is the main question the study is designed to answer.
b-wave amplitude
Measured: 1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op
Secondary outcomes (4)
a-wave amplitude
Measured: 1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op
macular vessel density
Measured: 1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op
Uncorrected visual acuity
Measured: 1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op
Best-corrected visual acuity
Measured: 1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start25 Aug 2025 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fuzhou Eye Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06966622
- Sponsor's protocol ID
- FZYKYY-KY-2025-002
- Status last verified
- May 2025
- First submitted
- 4 May 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ngenuity and Traditional Microscopy in Assessing Retinal Function Recovery Post-ICL Surgery
- ClinicalTrials.gov ID
- NCT06966622
- Acronym / sponsor ID
- FZYKYY-KY-2025-002
- Conditions
- High Myopia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fuzhou Eye HospitalUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 25 Aug 2025 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 13 May 2025 (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.
Implantable collamer lens (ICL) implantation is considered one of the most effective surgical treatments for high myopia. The procedure primarily involves adjusting the position of the ICL within the eye. However, precise calculation of the ICL optical power may cause the surgical light source to remain focused on the macular area during this process, potentially leading to iatrogenic light-induced damage. Theoretically, the combination of a 3D visualization surgical system and coaxial illumination technology can reduce the illumination intensity and decrease iatrogenic light damage. This study aims to compare the retinal physiological changes in patients undergoing ICL surgery through 3D visualization surgical system with coaxial illumination versus a traditional microscope with standard illumination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D visualization system | Experimental | Procedure: 3D visualization system with coaxial illumination |
| Microscope | Active comparator | Procedure: microscope with standard illumination |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Clinical diagnosis of high myopic
- Aged 18-40 years
- Desire to improve their refractive status via ICL surgery
- Relatively stable refractive error (change ≤ 0.50 D per year for two consecutive years)
- Central anterior chamber depth ≥ 2.8 mm
Key exclusion criteria (10 listed)
- Cataracts
- Corneal diseases,
- Glaucoma,
- Nystagmus,
- Strabismus,
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 |
|---|---|---|
| 3D visualization system with coaxial illuminationoperation through 3D visualization system with coaxial illumination | Procedure or surgery | 3D visualization system |
| microscope with standard illuminationoperation through microscope with standard illumination | Procedure or surgery | Microscope |
Primary outcome
b-wave amplitude
Time frame: 1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op
4 secondary outcomes
a-wave amplitude
Time frame: 1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op
macular vessel density
Time frame: 1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op
Uncorrected visual acuity
Time frame: 1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op
Best-corrected visual acuity
Time frame: 1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op
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 8 Aug 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing 3D visualization system with coaxial illumination and microscope with standard illumination in people with High Myopia, run by Fuzhou Eye Hospital.
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 7 inclusion and 10 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: opening soon, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
b-wave amplitude (time frame: 1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op). 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 8 Aug 2025.