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Intacs for Keratoconus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02138669
Recruitment Status : Recruiting
First Posted : May 14, 2014
Last Update Posted : January 14, 2021
Sponsor:
Information provided by (Responsible Party):
Steven Verity, University of Texas Southwestern Medical Center

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.

Condition or disease Intervention/treatment Phase
Keratoconus Device: Intacs Not Applicable

Detailed Description:

The INTACS procedure is typically performed in an outpatient setting. The two tiny INTACS inserts are surgically placed into the periphery of the cornea through a tiny cut that is made on the cornea after numbing drops have been applied. A specially designed instrument creates a tunnel by separating the tissue layers in the outside periphery of the cornea, the INTACS inserts are placed into this tunnel where they remain. One or two ophthalmic sutures will be placed to close the incision. A postoperative care information booklet will be given to the patients; patients will be followed by means of postoperative appointments for up to 12 months after the surgery. The visits/testing schedules are listed below:

Pre-OR visit (1.5 hours): Visual Acuity (VA), Refraction, Topography, Keratometry, Glare Test. Mesopic Pupil Size, Pachymetry, Tonometry, Slit Lamp Exam and Contrast Sensitivity.

Surgery (30min): At Laser Center for Vision Care which is part of Aston and department of Ophthalmology.

Post-OR Day 1(10min): VA, Slit Lamp Exam.

Post-OR 1week (20min): Visual Acuity, Refraction, Topography, Tonometry, Slit Lamp Exam.

Post-OR 1 month (20minj: Visual Acuity, Refraction, Topography, Tonometry, Slit Lamp Exam.

Post-OR 3 month (1.5 hours): Some as pre-op Visit.

Post-OR 6 month (20min): Visual Acuity, Refraction, Topography, Tonometry, Slit Lamp Exam.

Post-OR 12 month (1.5 hours): Same as pre-op.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: INTACS® Prescription Inserts Used to Treat Patients With Keratoconus as a Humanitarian Use Device
Study Start Date : January 2011
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Device: 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 Measures :
  1. Efficacy of INTACS prescription inserts to reduce astigmatism due to Keratoconus as determined by refraction assessment. [ Time Frame: 12 Months ]
    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.

  2. Efficacy of INTACS prescription inserts to reduce astigmatism due to Keratoconus as determined by visual acuity examination. [ Time Frame: 12 Months ]
    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.

  3. Efficacy of INTACS prescription inserts to reduce other corneal aberrations due to Keratoconus as determined by corneal topography assessment. [ Time Frame: 12 Months ]
    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.

  4. Efficacy of INTACS prescription inserts to reduce other corneal aberrations due to Keratoconus as determined by tonometry assessment. [ Time Frame: 12 Months ]
    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.

  5. Efficacy of INTACS prescription inserts to reduce other corneal aberrations due to Keratoconus as determined by slit lamp corneal examination. [ Time Frame: 12 Months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138669


Contacts
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Contact: Peter Chen, PhD 214-648-3837 Peter.Chen@UTSouthwestern.edu
Contact: Bonnie Miller, PhD 214-648-3826 Bonnie.Miller@UTSouthwestern.edu

Locations
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United States, Texas
UTSW Medical Center at Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Boris Patlis, BS    214-645-2015    Boris.Patlis@UTSouthwestern.edu   
Contact: Yesenia Leach, BA    214-645-2014    Yesenia.Leach@UTSouthwestern.edu   
Principal Investigator: Steven Verity, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Steven Verity, MD UTSW Medical Center at Dallas
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Responsible Party: Steven Verity, Professor of Medicine, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02138669    
Other Study ID Numbers: STU 012011-115
Intacs_Prospective ( Other Identifier: UTSW - Department of Ophthalmology )
First Posted: May 14, 2014    Key Record Dates
Last Update Posted: January 14, 2021
Last Verified: January 2021
Keywords provided by Steven Verity, University of Texas Southwestern Medical Center:
Cornea
Keratoconus
Steep cornea
Additional relevant MeSH terms:
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Keratoconus
Corneal Diseases
Eye Diseases