Intacs Inserts for Keratoconus Patients
This study is looking at how well INTACS® prescription inserts work for people with keratoconus, a condition where the cornea (the clear front part of your eye) thins and bulges. The goal is to see if these inserts can reduce astigmatism (blurry vision due to an imperfectly curved eye) and other vision problems caused by keratoconus. Researchers will measure changes in your vision and the shape of your cornea over 12 months. You might be able to join if you are at least 21 years old, have clear central corneas, and your vision has gotten worse even with glasses or contact lenses. The study aims to enroll 25 participants, but its current status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 25 participants. It is not specified if it is randomized or blinded.
- What's involved
- You would have a pre-surgery visit, the surgery itself (about 30 minutes), and follow-up appointments for up to 12 months. These appointments include various eye exams like visual acuity, refraction, and corneal topography.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 12 months after surgery, with primary endpoints measured at 12 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Intacs Prescription Inserts for Keratoconus Patients
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Steven Verity, MD · PRINCIPAL_INVESTIGATOR · UTSW Medical Center at Dallas
Who to contact
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What this trial measures
- Efficacy of INTACS prescription inserts to reduce astigmatism due to Keratoconus as determined by refraction assessment.12 Months
INTACS® prescription inserts are used to treat patients with Keratoconus as a Humanitarian Use Device. Efficacy of the INTACS inserts to reduce the effects of Keratoconus will be assessed using Refraction (pre-op refraction will be evaluated post-operatively) to assess the effectiveness of INTACS surgery in regards decreasing level of astigmatism.
- Efficacy of INTACS prescription inserts to reduce astigmatism due to Keratoconus as determined by visual acuity examination.12 Months
INTACS® prescription inserts are used to treat patients with Keratoconus as a Humanitarian Use Device. Efficacy of the INTACS inserts to reduce the effects of Keratoconus will be assessed using Visual Acuity to assess the effectiveness of INTACS surgery in regards decreasing level of astigmatism.
- Efficacy of INTACS prescription inserts to reduce other corneal aberrations due to Keratoconus as determined by corneal topography assessment.12 Months
Corneal Topography evaluation to assess post-operative vs. pre-operative corneal surface curvature differences will be used to measure efficacy of this INTACS prescription inserts, and an evaluation whether there is a need for further interventions, including corneal transplant.
- Efficacy of INTACS prescription inserts to reduce other corneal aberrations due to Keratoconus as determined by tonometry assessment.12 Months
Tonometry will be used to measure efficacy of this INTACS prescription inserts, and an evaluation whether there is a need for further interventions, including corneal transplant.
- Efficacy of INTACS prescription inserts to reduce other corneal aberrations due to Keratoconus as determined by slit lamp corneal examination.12 Months
Slit Lamp corneal examination will be used to measure efficacy of this INTACS prescription, and an evaluation whether there is a need for further interventions, including corneal transplant.