- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05518344
Study of Viziatek ISL™ Refractive Phakic Intra Sulcus Lens for Refraction Adjustment in Blind Volunteers
August 25, 2022 updated by: Hanita Lenses
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
4
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Riga, Latvia
- Drsolomatinisilmakeskus
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: single arm
|
Viziatek ISL™ (hereinafter referred to as the "ISL") implanted in blind eye.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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%.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ultrasound Biomicroscopy (UBM)
Time Frame: 6 months
|
All patients will undergo measurement of the central distance between implanted lens and anterior capsule to be greater than 50 microns (µm)
|
6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Slit Lamp Examination
Time Frame: 6 months
|
This includes measurement of aqueous cell and flare by a standard grading system and an evaluation for presence of corneal abnormalities; pupillary irregularities; iris atrophy and pigment dispersion
|
6 months
|
Pupillometry
Time Frame: 6 months
|
Pupil diameter in bright light (photopic condition): 2-4 mm Pupil diameter in the dark (mesopic/scotopic conditions): 4-8 mm The pupils are generally equal in size.
Pupil diameter is measured by digital pupilometer that measures distance between the center of each pupil.
|
6 months
|
Keratometry
Time Frame: 6 months
|
Measurement of the power of the cornea
|
6 months
|
Best corrected Visual Acuity
Time Frame: 6 months
|
Measurement by looking at ETDRS Chart with glasses
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 4, 2020
Primary Completion (Actual)
March 16, 2022
Study Completion (Actual)
March 16, 2022
Study Registration Dates
First Submitted
March 9, 2021
First Submitted That Met QC Criteria
August 25, 2022
First Posted (Actual)
August 26, 2022
Study Record Updates
Last Update Posted (Actual)
August 26, 2022
Last Update Submitted That Met QC Criteria
August 25, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VZT-19-002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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