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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: Recruiting NA study of Keratoconus, sponsored by University of Texas Southwestern Medical Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
What NCT02138669 shows while recruiting
NCT02138669 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 1,179-participant average among 21 other Keratoconus trials with a reported enrollment target (98% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Keratoconus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02138669's enrollment target sits among peer trials
25 22nd of 21 the lowest of 21 other Keratoconus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Keratoconus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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