Intacs Inserts for Keratoconus
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests Intacs, a small device placed in the eye to assist individuals with keratoconus, a condition causing the cornea to bulge into a cone shape. The goal is to improve vision and potentially avoid a corneal transplant. Suitable candidates have worsening vision not corrected by glasses or contacts and have been advised that a corneal transplant is their only option. Participants should have a clear central cornea and a minimum corneal thickness at the surgical site. As an unphased trial, this study provides a unique opportunity for patients to explore an alternative to corneal transplant surgery.
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 prior data suggests that the Intacs device is safe for treating keratoconus?
Research has shown that Intacs inserts, used to treat keratoconus, are generally safe for patients. The FDA first approved these inserts to correct mild nearsightedness and later for keratoconus. Studies indicate that most patients experience improved vision after the procedure. For instance, one study found that 72% of treated eyes improved by two or more lines on an eye chart, indicating a clear improvement in vision.
Although some patients might not notice changes, serious side effects are rare. Overall, Intacs is considered a safe and effective option for improving vision in people with keratoconus.12345Why are researchers excited about this trial?
Intacs Inserts are unique because they offer a non-invasive option for managing keratoconus, potentially delaying the need for a corneal transplant. Unlike standard treatments like rigid gas permeable lenses or corneal cross-linking, Intacs are tiny plastic inserts placed into the cornea to reshape it, reducing myopia and astigmatism. Researchers are excited because this approach can restore functional vision without the more invasive surgical procedures often required in advanced cases.
What evidence suggests that Intacs inserts are effective for keratoconus?
Research has shown that Intacs inserts, which participants in this trial will receive, effectively treat keratoconus, a condition affecting the eye. These inserts can improve vision and maintain the cornea, the clear front part of the eye, in a stable shape. One study found that Intacs enhanced vision clarity and reduced corneal irregularities over five years. Other data indicate that many patients notice improved vision within one to two years after receiving Intacs. Overall, Intacs inserts offer a promising option for managing keratoconus and may help delay the need for a corneal transplant.13467
Who Is on the Research Team?
Steven M Verity, MD
Principal Investigator
UTSW Medical Center at Dallas
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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