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Intacs Inserts for Keratoconus
Study Summary
This trial is for a device that corrects nearsightedness and keratoconus. The device is made of two clear segments from a biomedical material called polymethylmethacrylate, and is available in three thicknesses. Two INTACS inserts may be implanted depending on the orientation of the cone and the amount of myopia and astigmatism to be reduced.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- My cornea is thinner than usual, measuring 449 microns or less.My vision has worsened to the point where glasses or contacts no longer help me see well enough for daily tasks.I have eye conditions like corneal erosion or dystrophy that could cause future issues.My only option to see better is through corneal transplantation.I am currently taking isotretinoin or amiodarone.My cornea is thick enough for the surgery.My corneas are clear.I am 21 years old or older.
- Group 1: Intacs Device
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many individuals are being monitored in this scientific experiment?
"Affirmative. Per the information found on clinicaltrials.gov, this medical trial is presently looking for volunteers. It was first advertised in January 2011 and most recently updated in September 2022. The study requires 25 patients from a single location to participate.."
Is this research accepting new participants?
"Per information displayed on clinicaltrials.gov, this medical study is actively seeking enrolment from volunteers. This trial was first made public on January 1st 2011 and the most recent amendment to its details happened on September 30th 2022."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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