Intacs Prescription Inserts for Keratoconus Patients (NCT02138669)
INTACS® Prescription Inserts Used to Treat Patients With Keratoconus as a Humanitarian Use Device
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: UTSW Medical Center at Dallas — Dallas, Texas
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- UTSW Medical Center at Dallas — Dallas, Texas
📞 Contact the Study Coordinator
Phone: (214) 648-3837
Email: Peter.Chen@UTSouthwestern.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Keratoconus
- Initial Correction Keratoconus — Chicago, Illinois
- McNeel Eye Center Corneal Crosslinking Study — Boise, Idaho
- Assessing Patient Engagement in Keratoconus Clinical Research — San Francisco, California
- Outcomes of CTAK Surgery — Palo Alto, California
- A Randomized Clinical Trial of Ex Vivo Corneal Cross-Linking of Donor Keratoplasty Tissue for Keratoconus Used for Keratoplasty in Keratoconus Patients — Boston, Massachusetts
- OCT in Diagnosis of Irregular Corneas — Portland, Oregon
Explore by condition: All Keratoconus clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.