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

Primary Purpose

Myopia

Status

Terminated

Phase

Not Applicable

Locations

Latvia

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Drsolomatinisilmakeskus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

single arm

Arm Description

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.

Outcomes

Primary Outcome Measures

Endothelial cell loss

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

Secondary Outcome Measures

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)

Full Information

NCT ID

NCT05518344

First Posted

March 9, 2021

Last Updated

August 25, 2022

Sponsor

Hanita Lenses

1. Study Identification

Unique Protocol Identification Number

NCT05518344

Brief Title

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

Official Title

Clinical Investigation of "Viziatek ISL™ Refractive Phakic Intra Sulcus Lens" for Refraction Adjustment in Blind Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Terminated

Why Stopped

Sponsor decision to terminate the study

Study Start Date

June 4, 2020 (Actual)

Primary Completion Date

March 16, 2022 (Actual)

Study Completion Date

March 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hanita Lenses

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myopia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

single arm

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

Endothelial cell loss

Description

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

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Ultrasound Biomicroscopy (UBM)

Description

All patients will undergo measurement of the central distance between implanted lens and anterior capsule to be greater than 50 microns (µm)

Time Frame

6 months

Other Pre-specified Outcome Measures:

Title

Slit Lamp Examination

Description

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

Time Frame

6 months

Title

Pupillometry

Description

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.

Time Frame

6 months

Title

Keratometry

Description

Measurement of the power of the cornea

Time Frame

6 months

Title

Best corrected Visual Acuity

Description

Measurement by looking at ETDRS Chart with glasses

Time Frame

6 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Drsolomatinisilmakeskus

City

Riga

Country

Latvia

12. IPD Sharing Statement

Learn more about this trial

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

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