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

NCT06597292 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: VIS Opti-K-Presbyopia #001
• Study Type: interventional
• Target: 200
• Locations: 2 countries
• Sites: 2

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

Keywords

Vision improvement

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Vision improvement

EXPERIMENTAL

Device: Vision improvement

Interventions

Vision improvement DEVICE

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

Vision improvement

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who meet all of the following criteria are candidates for this study:
• Male or Female
• Any race
• Patient is at least 40 years old.
• Patient is pseudophakic or is phakic with no clinically significant cataract in eye(s) to be treated.
• 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.
• Patient has uncorrected distance visual acuity (UDVA) of 20/100 or better (i.e., LogMAR ≤ 0.70) in both eyes.
• Patient has best corrected distance visual acuity (CDVA) of 20/20 or better (i.e., LogMAR ≤ 0.00) in both eyes.
• 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.
• Patient has best corrected near visual acuity (CNVA) of at least 20/20 (LogMAR ≤ 0.00) in eye(s) to be treated.
• Patient requires reading adds of +1.0 to +3.0 D in eye(s) to be treated.
• Patient is not a contact lens (CL) wearer.
• Patient has normal corneal topography.
• Patient is willing and able to comply with all examinations.
• Patient must be competent to sign an informed consent form before study entry.

You may not qualify if:

• Subjects who meet any of the following criteria are to be excluded from this study:
• Corneal disease or corneal disorder in either eye.
• Any active ocular surface disease of any severity.
• Increased IOP (above 20 mm Hg), glaucoma or history of glaucoma.
• Previous corneal surgery in the eye to be treated.
• Conjunctivochalasis
• Nystagnus
• Diabetes
• Pregnancy
• 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: -

Sponsors & Collaborators

• VIS, Inc.: lead

Study Sites (2)

VIS, Inc.

Austin, Texas, 78731, United States

Location

Clarity Eye Institute

Toronto, Ontario, L4K 0J4, Canada

Location

MeSH Terms

Conditions

Hyperopia; Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Michael Berry, PhD

  VIS, Inc.

  STUDY DIRECTOR

Central Study Contacts

Michael Berry, PhD

CONTACT

8318691384; mberry177@gmail.com

Harry Glen, MD

CONTACT

561-252-0946; oceans11@bellsouth.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Patient IDs will be assigned and used.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2024
• First Posted: September 19, 2024
• Study Start: September 16, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (1)