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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

No Placebo-Only Group

Pivotal Trial

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 7Eligibility criteria met