MyopiaNCT07291739
A Clinical Evaluation of a Phakic Intraocular Lens
A study testing Implantable Collamer Lens (ICL) in people with Myopia and Hyperopia, run by Staar Surgical Company at 1 site in Philippines.
Trial summary
The objective of this study is to evaluate the clinical performance of the STAAR EVO+ Visian™ Implantable Collamer® Lens with Aspheric (EDOF) Optic as refractive elements to correct or reduce myopia or hyperopia with presbyopia with or without astigmatism. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Hyperopia, Astigmatism
- What is being tested?
- Implantable Collamer Lens (ICL)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 sitePhilippines
- Study dates
- 22 Aug 2022to 18 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Require a spherical lens power from -18.00 Diopters to +3.00 Diopters in both eyes or (in case of EDOF Toric) additional cylindrical lens power between +1.0 to +3.0 Diopters of Cylinder.
- Stable refractive history (+/-0.50 Diopters) as determined by manifest spherical equivalent.
- Requires +1.00 Diopters to +2.50 Diopters reading add in both eyes.
- Minimum distance corrected near visual acuity of 20/40 or worse in both eyes.
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- History of previous ocular surgery.
- Progressive sight threatening disease.
- Low/abnormal endothelial cell density.
- Monocular.
- Serious acute non-ophthalmic disease.
- Pregnant or nursing women, or those who plan to become pregnant over the course of the study.
- Other protocol-specified exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to evaluate the clinical performance of the STAAR EVO+ Visian™ Implantable Collamer® Lens with Aspheric (EDOF) Optic as refractive elements to correct or reduce myopia or hyperopia with presbyopia with or without astigmatism.
Read the detailed description
This prospective, open-labeled, evaluation of clinical performance of the investigational EDOF and Toric EDOF (TEDOF) ICL will be conducted at a single site in the Philippines.
Up to 45-50 subjects (90 eyes) who meet all eligibility criteria will be assigned to one of the following treatment arms, as determined by their preoperative refraction and the Investigator's medical judgement:
- EDOF Toric ICL in both eyes,
- EDOF Toric ICL in one eye and EDOF spherical ICL in fellow eye,
- EDOF spherical ICL in both eyes (up to 20 subjects/40 eyes).
Postoperatively, subjects will undergo ophthalmic examination at regular intervals per the study visit schedule up to 6 months after surgery.
- Conditions
- Myopia, Hyperopia, Astigmatism, Presbyopia
- Being tested
- Implantable Collamer Lens (ICL)
- Medical subject headings
- Myopia, Hyperopia, Astigmatism, Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable Collamer Lens (ICL)Device
EVO+ Visian Implantable Collamer Lens with Aspheric (EDOF) Optic models VTICM6/VTICH6 (TEDOF ICL) and VICM6/VICH6 (EDOF ICL)
| Study group | Role | What they receive |
|---|---|---|
| EDOF ICL | Other | Eyes treated EVO+ Visian and EVO+ Toric Implantable collamer lens with aspheric optic determined by their preoperative refraction Receives: Device: Implantable Collamer Lens (ICL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in visual acuity
Change from baseline in uncorrected distance, intermediate and near visual acuity and distance corrected near visual acuity
Measured: 1 month, 3 months and 6 months postoperatively
Change in refractive cylinder
Change from baseline in absolute magnitude of subjective refractive cylinder
Measured: 1 month, 3 months and 6 months postoperatively
Lens axis misalignment
Proportion of lenses with axis misalignment compared to operative day
Measured: 1 month, 3 months and 6 months postoperatively
Rotational stability
Rotational stability by assessment of IOL axis meridian compared to placement on day of surgery
Measured: 1 day, 1, week, 1 month, 3 months and 6 months postoperatively
Compromise in visual acuity
Clinically significant compromise in visual acuity based on subject questionnaires
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start22 Aug 2022
- Primary completion18 Oct 2024
- Study completion18 Oct 2024
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Staar Surgical Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07291739
- Sponsor's protocol ID
- CP18-01
- Status last verified
- Dec 2025
- First submitted
- 5 Dec 2025
- Last updated
- 18 Dec 2025
- 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 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of a Phakic Intraocular Lens
- ClinicalTrials.gov ID
- NCT07291739
- Acronym / sponsor ID
- CP18-01
- Conditions
- Myopia, Hyperopia, Astigmatism, Presbyopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Staar Surgical CompanyIndustry (pharma, biotech, devices)
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- 18 Oct 2024 (actual)
- Study completion
- 18 Oct 2024 (actual)
- First posted
- 18 Dec 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.
The objective of this study is to evaluate the clinical performance of the STAAR EVO+ Visian™ Implantable Collamer® Lens with Aspheric (EDOF) Optic as refractive elements to correct or reduce myopia or hyperopia with presbyopia with or without astigmatism.
Detailed description
This prospective, open-labeled, evaluation of clinical performance of the investigational EDOF and Toric EDOF (TEDOF) ICL will be conducted at a single site in the Philippines.
Up to 45-50 subjects (90 eyes) who meet all eligibility criteria will be assigned to one of the following treatment arms, as determined by their preoperative refraction and the Investigator's medical judgement:
- EDOF Toric ICL in both eyes,
- EDOF Toric ICL in one eye and EDOF spherical ICL in fellow eye,
- EDOF spherical ICL in both eyes (up to 20 subjects/40 eyes).
Postoperatively, subjects will undergo ophthalmic examination at regular intervals per the study visit schedule up to 6 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EDOF ICL | Other | Device: Implantable Collamer Lens (ICL)Eyes treated EVO+ Visian and EVO+ Toric Implantable collamer lens with aspheric optic determined by their preoperative refraction |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Require a spherical lens power from -18.00 Diopters to +3.00 Diopters in both eyes or (in case of EDOF Toric) additional cylindrical lens power between +1.0 to +3.0 Diopters of Cylinder.
- Stable refractive history (+/-0.50 Diopters) as determined by manifest spherical equivalent.
- Requires +1.00 Diopters to +2.50 Diopters reading add in both eyes.
- Minimum distance corrected near visual acuity of 20/40 or worse in both eyes.
- Other protocol-specified inclusion criteria may apply.
Key exclusion criteria (7 listed)
- History of previous ocular surgery.
- Progressive sight threatening disease.
- Low/abnormal endothelial cell density.
- Monocular.
- Serious acute non-ophthalmic disease.
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 |
|---|---|---|
| Implantable Collamer Lens (ICL)EVO+ Visian Implantable Collamer Lens with Aspheric (EDOF) Optic models VTICM6/VTICH6 (TEDOF ICL) and VICM6/VICH6 (EDOF ICL) | Device | EDOF ICL |
Primary outcome
Change in visual acuity
Time frame: 1 month, 3 months and 6 months postoperatively
Change from baseline in uncorrected distance, intermediate and near visual acuity and distance corrected near visual acuity
Change in refractive cylinder
Time frame: 1 month, 3 months and 6 months postoperatively
Change from baseline in absolute magnitude of subjective refractive cylinder
Lens axis misalignment
Time frame: 1 month, 3 months and 6 months postoperatively
Proportion of lenses with axis misalignment compared to operative day
Rotational stability
Time frame: 1 day, 1, week, 1 month, 3 months and 6 months postoperatively
Rotational stability by assessment of IOL axis meridian compared to placement on day of surgery
Compromise in visual acuity
Time frame: 6 months postoperatively
Clinically significant compromise in visual acuity based on subject questionnaires
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantable Collamer Lens (ICL) in people with Myopia and Hyperopia, run by Staar Surgical Company at 1 site in Philippines.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in visual acuity (time frame: 1 month, 3 months and 6 months postoperatively). The study lists 5 primary outcomes in all. 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 Dec 2025.