Study of Viziatek ISL™ Refractive Phakic Intra Sulcus Lens for Refraction Adjustment in Blind Volunteers

NCT05518344 | Terminated

• 1 other identifier: VZT-19-002
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• Endothelial cell loss

  Endothelial cell loss in operated eye measured at months 6, and change in cell count from baseline less than 10%.

  6 months

Secondary Outcomes (1)

• Ultrasound Biomicroscopy (UBM)

  6 months

Other Outcomes (4)

• Slit Lamp Examination

  6 months

• Pupillometry

  6 months

• Keratometry

  6 months

Study Arms (1)

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.

Device: Viziatek ISL™ (hereinafter referred to as the "ISL") implanted in blind eye.

Interventions

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.

single arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hanita Lenses: lead

Study Sites (1)

Drsolomatinisilmakeskus

Riga, Latvia

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: August 26, 2022
• Study Start: June 4, 2020
• Primary Completion: March 16, 2022
• Study Completion: March 16, 2022
• Last Updated: August 26, 2022

Record last verified: 2022-08

Locations

LA (1)