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Corneal Implant

Intacs Inserts for Keratoconus

N/A

Recruiting

Led By Steven Verity, MD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients who have experienced a progressive deterioration in their vision, such that they can no longer achieve adequate functional vision on a daily basis with their contact lenses or spectacles

Patients who have corneal transplantation as the only remaining option to improve their functional vision

Must not have

Patients who have abnormally thin corneas or who have a corneal thickness of 449 microns or less at the proposed incision site

Patients who are taking one or more of the following medications: isotretinoin (Accutane); amiodarone HCL (Cordarone)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is for a device that corrects nearsightedness and keratoconus. The device is made of two clear segments from a biomedical material called polymethylmethacrylate, and is available in three thicknesses. Two INTACS inserts may be implanted depending on the orientation of the cone and the amount of myopia and astigmatism to be reduced.

Who is the study for?

This trial is for adults over 21 with keratoconus, a condition that distorts the cornea. It's for those whose vision isn't helped enough by glasses or contacts and who have thick enough corneas (450 microns or more) at the incision site. People with very thin corneas, autoimmune diseases, pregnancy, certain eye conditions, or taking specific medications can't join.

What is being tested?

The trial tests INTACS prescription inserts made of PMMA material to treat keratoconus. These clear segments are implanted into the eye in varying thicknesses based on individual needs to improve vision without needing a full corneal transplant.

What are the potential side effects?

Potential side effects may include visual disturbances like glare and halos, discomfort or foreign body sensation in the eye, infection risk at the insertion site, and potential need for removal if complications arise.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My vision has worsened to the point where glasses or contacts no longer help me see well enough for daily tasks.

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My only option to see better is through corneal transplantation.

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My cornea is thick enough for the surgery.

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My corneas are clear.

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I am 21 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cornea is thinner than usual, measuring 449 microns or less.

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I am currently taking isotretinoin or amiodarone.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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

Astigmatism

Efficacy of INTACS prescription inserts to reduce astigmatism due to Keratoconus as determined by visual acuity examination.

Efficacy of INTACS prescription inserts to reduce other corneal aberrations due to Keratoconus as determined by corneal topography assessment.

+2 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Intacs DeviceExperimental Treatment1 Intervention

INTACS® prescription inserts are an ophthalmic medical device designed for the reduction or elimination of myopia and astigmatism in patients with keratoconus so that their functional vision may be restored and the need for a corneal transplant procedure can potentially be deferred.

0 / 7Eligibility criteria met

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Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,083 Previous Clinical Trials

1,058,164 Total Patients Enrolled

Steven Verity, MD4.06 ReviewsPrincipal Investigator - UTSW Medical Center at Dallas

University of Texas Southwestern Medical Center

5Patient Review

Dr. Verity was my Miracle Worker. I was functionally blind before my cataract surgery, but now everything is so colorful and beautiful. I'm grateful to God for him.