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NCT02138669 · ClinicalTrials.gov registry record · NA
Intacs Prescription Inserts for Keratoconus Patients
A NA study of Keratoconus, sponsored by University of Texas Southwestern Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT02138669 is a NA study of Keratoconus that is actively recruiting participants, run by University of Texas Southwestern Medical Center. The registered enrollment target is 25 participants, below the 1,179-participant average among 21 other Keratoconus trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02138669, a NA study of Keratoconus, is actively recruiting participants, sponsored by University of Texas Southwestern Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
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). The statute and the implementing regulation of FDA (21 CFR 814.124 (aj) require IRB review and approval before a HUD is used.INTACS prescription inserts are composed of two clear segments, each having an arc length of 150°, they are manufactured form a biomedical material called polymethylmethacrylate (PMMA) and are available in three thicknesses. Two INTACS inserts ranging from 0.250mm to 0.350mm may be implanted depending on the orientation of the cone and the amount of myopia and astigmatism to be reduced.
Conditions Studied
Interventions
- DEVICE Intacs
Study Locations (1)
Texas
- UTSW Medical Center at Dallas - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2011-01 |
| Est. Completion | 2030-07-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02138669
The ClinicalTrials.gov registry entry for NCT02138669 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,179-participant average among 21 other Keratoconus trials with a reported enrollment target (98% lower). The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Keratoconus appearing as the primary indexed condition, and to 1 intervention - of which Intacs is the first listed.
NCT02138669 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT02138669 about?
NCT02138669 is a clinical study titled "Intacs Prescription Inserts for Keratoconus Patients". 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...
What is the current status of trial NCT02138669?
This trial is currently recruiting. It is a NA study. The enrollment target is 25 participants. The study started on 2011-01. Estimated completion is 2030-07-31.
What conditions does trial NCT02138669 study?
This clinical trial studies the following conditions: Keratoconus.
What interventions are being tested in trial NCT02138669?
The interventions under investigation include: Intacs (DEVICE).
Who is sponsoring clinical trial NCT02138669?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02138669 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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