MyopiaNCT05518344
Study of Viziatek ISL™ Refractive Phakic Intra Sulcus Lens for Refraction Adjustment in Blind Volunteers
A study testing Viziatek ISL™ (hereinafter referred to as the "ISL") implanted in blind eye. in people with Myopia, run by Hanita Lenses at 1 site in Latvia.
Trial summary
This is a clinical investigation. A total of up to 5 subjects, but not less than 3 at one investigational site will undergo insertion of the ISL in one eye and will be followed through 6 months postoperative. Subjects from the United States will not be enrolled in this study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myopia
- What is being tested?
- Viziatek ISL™ (hereinafter referred to as the "ISL") implanted in blind eye.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteLatvia
- Study dates
- 4 Jun 2020to 16 Mar 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects must sign and be given a copy of the signed Informed Consent Form (ICF).
- Subjects must be legally blind.
- Subjects must have best-corrected distance visual acuity of 20/400 or worse.
- Subjects must have an endothelial cell count ≥ 1800 cells/mm2 in the eye to be implanted.
- Subjects must have a photopic pupil size of > 2 mm in the eye to be implanted.
- Anterior chamber depth (ACD) ≥ 2.8 mm
- Anterior chamber angle ≥ Grade III
- Subjects must be willing and able to return for scheduled follow-up examinations for 12 months after surgery if asked.
Who cannot join
- Subjects who have best-corrected visual acuity of better than 20/400
- Subjects with clinically significant anterior segment pathology, including cataracts, in either eye.
- Subjects with residual, recurrent, active ocular or uncontrolled eyelid disease or any progressive corneal abnormalities (including endothelial dystrophy, guttate in the central cornea, etc.) in the eye to be treated.
- Subjects with a history of the chronic dry eye not controlled on therapy or with superficial punctuate keratitis (SPK) grade > II (i.e., greater than mild) based on Oxford Grading Scale12 in the eye to be treated.
- Subjects who have undergone previous intraocular or corneal surgery including cataract and refractive surgery (e.g., LASIK surgery) in either eye.
- Subjects using ophthalmic medication(s) other than artificial tears for treatment of ocular pathology.
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- Subjects with a history of autoimmune disease, connective tissue disease, or clinically significant atopic syndrome.
- Subjects with a history of herpes zoster or herpes simplex keratitis.
- Subjects with a history of a steroid-responsive rise in intraocular pressure (IOP), or a preoperative IOP > 21 mmHg or glaucoma.
- Subjects with distorted, non-reactive, or decentered pupils.
- Subjects on chronic systemic or topical corticosteroids or other immunosuppressive therapy that may affect wound healing, and any immuno-compromised subjects (use of intranasal steroids for seasonal allergies are acceptable).
- Subjects using systemic medications with significant ocular side effects.
- Subjects who are pregnant or are considering becoming pregnant during the time of the study.
- Subjects with known sensitivity to planned study concomitant medications.
- Subjects who are participating in any other drug or device clinical investigation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Investigation of "Viziatek ISL™ Refractive Phakic Intra Sulcus Lens" for Refraction Adjustment in Blind Volunteers
This is a clinical investigation. A total of up to 5 subjects, but not less than 3 at one investigational site will undergo insertion of the ISL in one eye and will be followed through 6 months postoperative.
Subjects from the United States will not be enrolled in this study.
Read the detailed description
The Viziatek ISL is intended to improve myopic vision and decrease dependence on glasses in myopic adults who don't have an irregular astigmatic cornea (as evaluated by topography), who require correction of -3.50 D to -23 D, who have BCVA - Distance between 20/20 to 20/30 and with no more than 5 D of the refractive cylinder, and who have stable MRSE within 0.50 D over the past 12 months.
- Conditions
- Myopia
- Being tested
- Viziatek ISL™ (hereinafter referred to as the "ISL") implanted in blind eye.
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viziatek ISL™ (hereinafter referred to as the "ISL") implanted in blind eye.Device
Viziatek ISL™ (hereinafter referred to as the "ISL") implanted in blind eye.
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | * Release ISL from Inserter
* Remove Inserter.
* Tack the haptics under the iris in 4 locations
* Verify that ISL is centered
* Remove lid speculum and drape from subject's eye and face.
* Move the subject to a slit lamp and verify ISL centration. Receives: Device: Viziatek ISL™ (hereinafter referred to as the "ISL") implanted in blind eye. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial cell loss
Endothelial cell loss in operated eye measured at months 6, and change in cell count from baseline less than 10%.
Measured: 6 months
Secondary outcomes (1)
Ultrasound Biomicroscopy (UBM)
All patients will undergo measurement of the central distance between implanted lens and anterior capsule to be greater than 50 microns (µm)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start4 Jun 2020
- Primary completion16 Mar 2022
- Study completion16 Mar 2022
Why it stopped: Sponsor decision to terminate the study
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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanita Lenses
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05518344
- Sponsor's protocol ID
- VZT-19-002
- Status last verified
- Aug 2022
- First submitted
- 9 Mar 2021
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of "Viziatek ISL™ Refractive Phakic Intra Sulcus Lens" for Refraction Adjustment in Blind Volunteers
- ClinicalTrials.gov ID
- NCT05518344
- Acronym / sponsor ID
- VZT-19-002
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision to terminate the study
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Hanita LensesIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2020 (actual)
- Primary completion
- 16 Mar 2022 (actual)
- Study completion
- 16 Mar 2022 (actual)
- First posted
- 26 Aug 2022 (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 is a clinical investigation. A total of up to 5 subjects, but not less than 3 at one investigational site will undergo insertion of the ISL in one eye and will be followed through 6 months postoperative.
Subjects from the United States will not be enrolled in this study.
Detailed description
The Viziatek ISL is intended to improve myopic vision and decrease dependence on glasses in myopic adults who don't have an irregular astigmatic cornea (as evaluated by topography), who require correction of -3.50 D to -23 D, who have BCVA - Distance between 20/20 to 20/30 and with no more than 5 D of the refractive cylinder, and who have stable MRSE within 0.50 D over the past 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Device: Viziatek ISL™ (hereinafter referred to as the "ISL") implanted in blind eye.* Release ISL from Inserter * Remove Inserter. * Tack the haptics under the iris in 4 locations * Verify that ISL is centered * Remove lid speculum and drape from subject's eye and face. * Move the subject to a slit lamp and verify ISL centration. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects must sign and be given a copy of the signed Informed Consent Form (ICF).
- Subjects must be legally blind.
- Subjects must have best-corrected distance visual acuity of 20/400 or worse.
- Subjects must have an endothelial cell count ≥ 1800 cells/mm2 in the eye to be implanted.
- Subjects must have a photopic pupil size of > 2 mm in the eye to be implanted.
Key exclusion criteria (15 listed)
- Subjects who have best-corrected visual acuity of better than 20/400
- Subjects with clinically significant anterior segment pathology, including cataracts, in either eye.
- Subjects with residual, recurrent, active ocular or uncontrolled eyelid disease or any progressive corneal abnormalities (including endothelial dystrophy, guttate in the central cornea, etc.) in the eye to be treated.
- Subjects with a history of the chronic dry eye not controlled on therapy or with superficial punctuate keratitis (SPK) grade > II (i.e., greater than mild) based on Oxford Grading Scale12 in the eye to be treated.
- Subjects who have undergone previous intraocular or corneal surgery including cataract and refractive surgery (e.g., LASIK surgery) in either eye.
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 |
|---|---|---|
| Viziatek ISL™ (hereinafter referred to as the "ISL") implanted in blind eye.Viziatek ISL™ (hereinafter referred to as the "ISL") implanted in blind eye. | Device | single arm |
Primary outcome
Endothelial cell loss
Time frame: 6 months
Endothelial cell loss in operated eye measured at months 6, and change in cell count from baseline less than 10%.
1 secondary outcome
Ultrasound Biomicroscopy (UBM)
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Sponsor decision to terminate the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
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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 Viziatek ISL™ (hereinafter referred to as the "ISL") implanted in blind eye. in people with Myopia, run by Hanita Lenses at 1 site in Latvia.
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 15 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: stopped early, as of the sponsor's last update on 26 Aug 2022. 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 Latvia. 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 was stopped early (reason given: Sponsor decision to terminate the study). Results are not available in the source record.
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?
Endothelial cell loss (time frame: 6 months). 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 26 Aug 2022.