Recruiting

Intacs

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT02138669

Conditions

Keratoconus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intacs

Study Details

Brief 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

Keratoconus

Study ID

NCT02138669

Start date

Jan, 2011

Status verified date

Apr, 2026

Completion date

Jul 31, 2030

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Who have experienced a progressive deterioration in their vision, such thot they can no longer achieve adequate functional vision on a daily basis with their contact lenses or spectacles; Who are 21 years of age or older; Who have clear central corneas; Who have a corneal thickness of 450 microns or greater at the proposed incision site; Who have corneal transplantation as the only remaining option to improve their functional vision.

Exclusion Criteria:

Who have abnormally thin corneas or who have a corneal thickness of 449 microns or less at the proposed incision site;

Patients with collagen vascular, autoimmune or immunodeficiency disease;

Pregnant or nursing patients;

Presence of ocular conditions, such as recurrent corneal erosion syndrome or corneal dystrophy, that my predispose the patient to future complications;

Patients who are taking on or more of following medications: isotretinoin (Accutane); amiodarone HCL (Cordarone).

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Intacs

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 ]
  • Efficacy of INTACS prescription inserts to reduce astigmatism due to Keratoconus as determined by visual acuity examination. [ Time Frame: 12 Months ]
  • Efficacy of INTACS prescription inserts to reduce other corneal aberrations due to Keratoconus as determined by corneal topography assessment. [ Time Frame: 12 Months ]
  • Efficacy of INTACS prescription inserts to reduce other corneal aberrations due to Keratoconus as determined by tonometry assessment. [ Time Frame: 12 Months ]
  • Efficacy of INTACS prescription inserts to reduce other corneal aberrations due to Keratoconus as determined by slit lamp corneal examination. [ Time Frame: 12 Months ]

Central Contacts and Locations

Central contacts

Peter Chen, PhD

214-648-3837Peter.Chen@UTSouthwestern.edu

Asha Varghese, MS

214-648-3087Asha.Varghese@UTSouthwestern.edu

Locations

UTSW Medical Center at Dallas

Recruiting

Dallas, Texas, United States, 75390

Contacts

Boris Patlis, MS

214-645-2015Boris.Patlis@UTSouthwestern.edu

Principal Investigator:

Steven Verity, MD

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Apr 9, 2026

Last verified

Apr, 2026

Keywords

  • Cornea
  • Keratoconus
  • Steep cornea

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-04-09.