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

Vision Improvement for Patients With Presbyopia

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

Study Overview

• Status: Not yet recruiting
• Conditions: Presbyopia; Hyperopia
• Intervention / Treatment: Device: Vision improvement

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Berry, PhD; Phone Number: 8318691384; Email: mberry177@gmail.com
• Study Contact Backup: Name: Harry Glen, MD; Phone Number: 561-252-0946; Email: oceans11@bellsouth.net

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, L4K 0J4
      • Clarity eye Institute
      • Contact: Arvind Kattar; Phone Number: 416-278-3202; Email: akattar@clarityeye.ca
      • Principal Investigator: :Paul Sanghera, MD
• United States
  • Texas
    • Austin, Texas, United States, 78731
      • VIS, Inc.
      • Contact: Michael Berry, PhD; Phone Number: 831-869-1384; Email: mberry177@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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: -

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vision improvement	Device: Vision improvement; Vision improvement for patients with refractive disorders (hyperopia and presbyopia)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uncorrected Distance Visual Acuity (UDVA)	Uncorrected distance visual acuity (UDVA) is to be measured and reported using standard ETDRS visual acuity charts. UDVA change from baseline is also to be reported.	Up to 24 months post-treatment
Uncorrected Near Visual Acuity (UNVA)	Uncorrected near visual acuity (UNVA) is to be measured and reported using standard near visual acuity charts. UNVA change from baseline is also to be reported.	Up to 24 months post-treatment

Collaborators and Investigators

• Sponsor: VIS, Inc.
• Investigators: Study Director: Michael Berry, PhD, VIS, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): September 16, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: August 30, 2024
• First Submitted That Met QC Criteria: September 11, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): September 25, 2024
• Last Update Submitted That Met QC Criteria: September 23, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Vision improvement
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia; Hyperopia
• Other Study ID Numbers: VIS Opti-K-Presbyopia #001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes