The VIS Opti-K Low Vision Aid Device Provides Vision Impr... | NCT06597292

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

NCT06597292

Sponsor

VIS, Inc.

Status

Not yet recruiting

Last Update Posted

Sep 25, 2024Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Hyperopia
Presbyopia

Interventions

Vision improvement

Countries

United States
Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 16, 2024Estimated

Primary Completion Date

Sep 30, 2026Estimated

Completion Date

Dec 30, 2026Estimated

First Submitted Date

Aug 30, 2024

First Submission Date that Met QC Criteria

Sep 11, 2024

First Posted Date

Sep 19, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 23, 2024

Last Update Posted Date

Sep 25, 2024Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Label	Type	Description	Intervention Names
Vision improvement	Experimental		Device: Vision improvement

Name	Type	Description	Arm Group Labels	Other Names
Vision improvement	Device	Vision improvement for patients with refractive disorders (hyperopia and presbyopia)	Vision improvement

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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: -

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Michael Berry, PhD	Contact	8318691384		mberry177@gmail.com
Harry Glen, MD	Contact	561-252-0946		oceans11@bellsouth.net

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases

ID	Term
D006956	Hyperopia
D011305	Presbyopia