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Procedure

Laser Keratoplasty for Presbyopia (Opti-K™ Trial)

Phase 3
Recruiting
Research Sponsored by VIS, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject age is equal to or greater than 40 years old
Be older than 18 years old
Must not have
Previous intraocular or corneal surgery of any kind in either eye
Nystagmus
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Summary

"This trial aims to test a new system called VIS Opti-K to help improve near vision in one eye for people with certain vision problems. The main focus is to see how well it works in improving

Who is the study for?
This trial is for people with presbyopia, which is difficulty in reading or seeing at close range as they age. Participants should be slightly nearsighted, have normal vision (emmetropic), or be slightly farsighted. The treatment will focus on the non-dominant eye to improve near vision temporarily.
What is being tested?
The VIS Opti-K System is being tested for its ability to correct presbyopia by treating the non-dominant eye. This Phase III trial measures how well subjects can see up close without glasses after treatment and checks their satisfaction through a questionnaire.
What are the potential side effects?
Potential side effects may include discomfort in the treated eye, changes in vision that could affect depth perception or cause glare and halos, especially at night, and possibly a need for retreatment if initial results fade over time.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 40 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had eye surgery before.
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I experience involuntary eye movements.
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My eyes have a condition where the outer layer is loose or redundant.
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I have an eye condition affecting the surface of my eye.
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I have a condition that makes my cornea cloudy.
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I have used eye drops with preservatives or cytotoxic drugs within the last week.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Uncorrected near visual acuity 2 or more lines or better
Secondary study objectives
Binocular uncorrected near visual acuity
Other study objectives
Percentage of eyes that achieve UNVA
Subjective improvement in vision

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single arm treatment with the VIS Optimal Keratoplasty (Opti-K™) SystemExperimental Treatment1 Intervention
Subjects who accept monovision will receive Opti-K™ treatment in the non-dominant eye. The fellow eye will not receive Opti-K™ treatment in this Pivotal Study. Eligible subjects will undergo a single retreatment

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Who is running the clinical trial?

VIS, Inc.Lead Sponsor
1 Previous Clinical Trials
200 Total Patients Enrolled
Total Diversity Clinical Trial ManagementUNKNOWN
Harry Glen, M.D.Study Director
~50 spots leftby Dec 2026
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