Actively Recruiting
Intacs Prescription Inserts for Keratoconus Patients
Led by University of Texas Southwestern Medical Center · Updated on 2026-04-09
25
Participants Needed
1
Research Sites
1021 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The US food and Drug Administration (FDA) originally approved INTACS prescription inserts in April 1999 for the correction of low levels of nearsightedness (-1.00 to -3.00 diopters). Additional clinical data have shown that INTACS are safe for the treatment of keratoconus, in July 2004, FDA approved INTACS inserts for the treatment of keratoconus as a Humanitarian Use Device (FDA approval letter attached). The statute and the implementing regulation of FDA (21 CFR 814.124 (aj) require IRB review and approval before a HUD is used.INTACS prescription inserts are composed of two clear segments, each having an arc length of 150°, they are manufactured form a biomedical material called polymethylmethacrylate (PMMA) and are available in three thicknesses. Two INTACS inserts ranging from 0.250mm to 0.350mm may be implanted depending on the orientation of the cone and the amount of myopia and astigmatism to be reduced.
CONDITIONS
Official Title
Intacs Prescription Inserts for Keratoconus Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Experienced progressive vision deterioration making contact lenses or glasses inadequate for daily functional vision
- 21 years of age or older
- Clear central corneas
- Corneal thickness of 450 microns or greater at the proposed incision site
- Corneal transplantation is currently the only option to improve functional vision
You will not qualify if you...
- Corneal thickness of 449 microns or less at the proposed incision site
- Presence of collagen vascular, autoimmune, or immunodeficiency diseases
- Pregnant or nursing
- Ocular conditions like recurrent corneal erosion syndrome or corneal dystrophy that increase risk of complications
- Use of medications such as isotretinoin (Accutane) or amiodarone HCL (Cordarone)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UTSW Medical Center at Dallas
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
P
Peter Chen, PhD
CONTACT
A
Asha Varghese, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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