The VIS Opti-K Low Vision Aid Device Provides Vision Improvement.

NCT ID: NCT06597292

Last Updated: 2024-09-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-16
• Study Completion Date: 2026-12-30

Brief Summary

The VIS Opti-K Low Vision Aid device will be used to provide vision improvement to patients with refractive disorders (hyperopia and presbyopia).

Conditions

Hyperopia; Presbyopia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vision improvement

Group Type: EXPERIMENTAL

Vision improvement

Intervention Type: DEVICE

Vision improvement for patients with refractive disorders (hyperopia and presbyopia)

Interventions

Vision improvement

Vision improvement for patients with refractive disorders (hyperopia and presbyopia)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Subjects who meet all of the following criteria are candidates for this study:

1. Male or Female

2. Any race

3. Patient is at least 40 years old.

4. Patient is pseudophakic or is phakic with no clinically significant cataract in eye(s) to be treated.

5. Patient has manifest refraction, spherical equivalent (MRSE) between -0.50 D to 2.50 D, with no more than 1.0 D of refractive cylinder, in eye(s) to be treated.

6. Patient has uncorrected distance visual acuity (UDVA) of 20/100 or better (i.e., LogMAR ≤ 0.70) in both eyes.

7. Patient has best corrected distance visual acuity (CDVA) of 20/20 or better (i.e., LogMAR ≤ 0.00) in both eyes.

8. Patient has uncorrected near visual acuity (UNVA) between 20/50 (LogMAR 0.40) and better than 20/100 (LogMAR < 0.70) in eye(s) to be treated.

9. Patient has best corrected near visual acuity (CNVA) of at least 20/20 (LogMAR ≤ 0.00) in eye(s) to be treated.

10. Patient requires reading adds of +1.0 to +3.0 D in eye(s) to be treated.

11. Patient is not a contact lens (CL) wearer.

12. Patient has normal corneal topography.

13. Patient is willing and able to comply with all examinations.

14. Patient must be competent to sign an informed consent form before study entry.

Exclusion Criteria

Subjects who meet any of the following criteria are to be excluded from this study:

1. Corneal disease or corneal disorder in either eye.

2. Any active ocular surface disease of any severity.

3. Increased IOP (above 20 mm Hg), glaucoma or history of glaucoma.

4. Previous corneal surgery in the eye to be treated.

5. Conjunctivochalasis

6. Nystagnus

7. Diabetes

8. Pregnancy

9. Presence or history of any other condition or finding that, in the opinion of the investigator, makes the patient unsuitable as a candidate for study participation or that may confound the outcome of the study.

nclusion Criteria: -

-

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VIS, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Berry, PhD

Role: STUDY_DIRECTOR

VIS, Inc.

Locations

VIS, Inc.

Austin, Texas, United States

Clarity Eye Institute

Toronto, Ontario, Canada

Countries

United States; Canada

Central Contacts

Michael Berry, PhD

Role: CONTACT

mberry177@gmail.com

8318691384

Harry Glen, MD

Role: CONTACT

oceans11@bellsouth.net

561-252-0946

Facility Contacts

Michael Berry, PhD

Role: primary

mberry177@gmail.com

831-869-1384

Arvind Kattar

Role: primary

akattar@clarityeye.ca

416-278-3202

Other Identifiers

VIS Opti-K-Presbyopia #001

Identifier Type: -

Identifier Source: org_study_id