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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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

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.

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,055 Previous Clinical Trials
1,054,884 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.

Media Library

Intacs (Corneal Implant) Clinical Trial Eligibility Overview. Trial Name: NCT02138669 — N/A
Keratoconus Research Study Groups: Intacs Device
Keratoconus Clinical Trial 2023: Intacs Highlights & Side Effects. Trial Name: NCT02138669 — N/A
Intacs (Corneal Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02138669 — N/A
~1 spots leftby Dec 2024
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