NCT06702020

Brief Summary

The VIS Opti-K device and procedure were used to provide vision improvement to patients with presbyopia.

Trial Health

53
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2007

Longer than P75 for all trials

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 13, 2007

Completed
17.7 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 22, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

November 22, 2024

Status Verified

November 1, 2024

Enrollment Period

18.1 years

First QC Date

November 19, 2024

Last Update Submit

November 19, 2024

Conditions

Presbyopia Correction

Outcome Measures

Primary Outcomes (1)

  • Uncorrected distance and near visual acuities

    Uncorrected distance and near visual acuities are measured using ETDRS or similar charts.

    Up to 24 months post-treatment

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients had documented presbyopia and a need for near vision improvement

You may qualify if:

  • Female or male Any race 40 years of age or older Presbyopia

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

Study Officials

  • Michael J Berry, PhD

    VIS, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2024

First Posted

November 22, 2024

Study Start

March 13, 2007

Primary Completion

March 31, 2025

Study Completion

July 31, 2025

Last Updated

November 22, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

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