Intacs Inserts for Keratoconus
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
If you are taking isotretinoin (Accutane) or amiodarone HCL (Cordarone), you will need to stop these medications to participate in the trial.
What data supports the effectiveness of the treatment Intacs for keratoconus?
Research shows that Intacs, which are tiny ring segments placed in the cornea (the clear front part of the eye), can help improve vision in people with moderate to severe keratoconus, a condition where the cornea becomes cone-shaped and thin. Studies have found that Intacs can be effective in managing keratoconus by flattening the cornea and improving its shape, leading to better vision.12345
How is the Intacs treatment different from other treatments for keratoconus?
Intacs inserts are unique because they are small, crescent-shaped devices implanted in the cornea (the clear front part of the eye) to reshape it and improve vision in people with keratoconus, especially those who cannot tolerate contact lenses. Unlike other treatments, Intacs do not involve removing any corneal tissue, making them a less invasive option.12456
Research Team
Steven M Verity, MD
Principal Investigator
UTSW Medical Center at Dallas
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Pre-Operative Assessment
Pre-OR visit includes Visual Acuity, Refraction, Topography, Keratometry, Glare Test, Mesopic Pupil Size, Pachymetry, Tonometry, Slit Lamp Exam, and Contrast Sensitivity
Surgery
INTACS inserts are surgically placed into the cornea
Post-Operative Follow-up
Post-OR visits at Day 1, 1 week, 1 month, 3 months, 6 months, and 12 months to monitor Visual Acuity, Refraction, Topography, Tonometry, and Slit Lamp Exam
Long-term Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Intacs
Intacs is already approved in United States for the following indications:
- Keratoconus
- Low levels of nearsightedness (-1.00 to -3.00 diopters)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Texas Southwestern Medical Center
Lead Sponsor