Intacs Prescription Inserts for Keratoconus Patients

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT02138669
Status
Recruiting
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Conditions

  • Keratoconus

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intacs — DEVICE
    INTACS® prescription inserts are an ophthalmic medical device designed for the reduction or elimination of myopia and astigmatism in patients with keratoconus so that their functional vision may be restored and the need for a corneal transplant procedure can potentially be deferred.

Study Details

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.

Key Dates

Start date
Jan 31, 2011
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Jul 31, 2030

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Intacs Device
    INTACS® prescription inserts are an ophthalmic medical device designed for the reduction or elimination of myopia and astigmatism in patients with keratoconus so that their functional vision may be restored and the need for a corneal transplant procedure can potentially be deferred.

Primary Outcome Measure

Efficacy of INTACS prescription inserts to reduce astigmatism due to Keratoconus as determined by refraction assessment. [ Time Frame: 12 Months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UTSW Medical Center at DallasDallasTexas75390
Boris Patlis, MS
[email protected]
214-645-2015
Steven Verity, MD (PRINCIPAL_INVESTIGATOR)

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By research site
UTSW Medical Center at Dallas· Dallas, TX

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