Intacs Prescription Inserts for Keratoconus Patients

NCT02138669 | Recruiting

• 2 other identifiers: STU 012011-115Intacs_Prospective
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Keywords

Cornea; Keratoconus; Steep cornea

Outcome Measures

Primary Outcomes (5)

• Efficacy of INTACS prescription inserts to reduce astigmatism due to Keratoconus as determined by refraction assessment.

  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.

  12 Months

• Efficacy of INTACS prescription inserts to reduce astigmatism due to Keratoconus as determined by visual acuity examination.

  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 Visual Acuity to assess the effectiveness of INTACS surgery in regards decreasing level of astigmatism.

  12 Months

• Efficacy of INTACS prescription inserts to reduce other corneal aberrations due to Keratoconus as determined by corneal topography assessment.

  Corneal Topography evaluation to assess post-operative vs. pre-operative corneal surface curvature differences will be used to measure efficacy of this INTACS prescription inserts, and an evaluation whether there is a need for further interventions, including corneal transplant.

  12 Months

• Efficacy of INTACS prescription inserts to reduce other corneal aberrations due to Keratoconus as determined by tonometry assessment.

  Tonometry will be used to measure efficacy of this INTACS prescription inserts, and an evaluation whether there is a need for further interventions, including corneal transplant.

  12 Months

• Efficacy of INTACS prescription inserts to reduce other corneal aberrations due to Keratoconus as determined by slit lamp corneal examination.

  Slit Lamp corneal examination will be used to measure efficacy of this INTACS prescription, and an evaluation whether there is a need for further interventions, including corneal transplant.

  12 Months

Study Arms (1)

Intacs Device

OTHER

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.

Device: Intacs

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.

Intacs Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UTSW Medical Center at Dallas

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Keratoconus; Corneal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Steven Verity, MD

  UTSW Medical Center at Dallas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Chen, PhD

CONTACT

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

Asha Varghese, MS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: May 5, 2014
• First Posted: May 14, 2014
• Study Start: January 1, 2011
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): July 31, 2030
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

US (1)