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New treatment option for Keratoconus
Official title Intacs Prescription Inserts for Keratoconus Patients
ClinicalTrials.gov ID: NCT02138669
What this study is testing
- What it's testing
- 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).
- Time commitment: about 12 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Who have experienced a progressive deterioration in their vision, such thot they can no longer achieve adequate functional vision on a daily basis...
You likely can't join if
- 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...
- Patients who are taking on or more of following medications: isotretinoin (Accutane); amiodarone HCL (Cordarone).
The study team makes the final eligibility decision.
Where it's taking place
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dallas, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.