Treatment for Keratoconus with INTACS Inserts
INTACS® Prescription Inserts Used to Treat Patients With Keratoconus as a Humanitarian Use Device
NA · University of Texas Southwestern Medical Center · NCT02138669
This study is testing whether using special inserts in the eyes can help people with keratoconus see better by reshaping their corneas.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center (other) |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT02138669 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the use of INTACS prescription inserts for patients with keratoconus, a condition that causes progressive vision deterioration. The procedure involves surgically placing two clear INTACS inserts into the cornea to improve vision by reshaping the cornea. Patients will undergo a series of pre-operative and post-operative assessments to monitor visual acuity and corneal health over a 12-month period. The inserts are made from a biomedical material and are designed to be minimally invasive, allowing for outpatient treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and older with progressive keratoconus and clear central corneas who have not responded to other vision correction methods.
Not a fit: Patients with thin corneas, autoimmune diseases, or certain ocular conditions may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly improve vision and quality of life for patients with keratoconus who cannot achieve adequate vision with glasses or contact lenses.
How similar studies have performed: Previous studies have shown that INTACS inserts can be effective for treating keratoconus, indicating a promising approach for this condition.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Who have experienced a progressive deterioration in their vision, such thot they can no longer achieve adequate functional vision on a daily basis with their contact lenses or spectacles; Who are 21 years of age or older; Who have clear central corneas; Who have a corneal thickness of 450 microns or greater at the proposed incision site; Who have corneal transplantation as the only remaining option to improve their functional vision. Exclusion Criteria: Who have abnormally thin corneas or who have a corneal thickness of 449 microns or less at the proposed incision site; Patients with collagen vascular, autoimmune or immunodeficiency disease; Pregnant or nursing patients; Presence of ocular conditions, such as recurrent corneal erosion syndrome or corneal dystrophy, that my predispose the patient to future complications; Patients who are taking on or more of following medications: isotretinoin (Accutane); amiodarone HCL (Cordarone).
Where this trial is running
Dallas, Texas
- UTSW Medical Center at Dallas — Dallas, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Steven Verity, MD — UTSW Medical Center at Dallas
- Study coordinator: Peter Chen, PhD
- Email: Peter.Chen@UTSouthwestern.edu
- Phone: 214-648-3837
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Keratoconus, Cornea, Steep cornea