Intacs for Keratoconus
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ClinicalTrials.gov Identifier: NCT02138669 |
Recruitment Status :
Recruiting
First Posted : May 14, 2014
Last Update Posted : October 4, 2022
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Condition or disease | Intervention/treatment | Phase |
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Keratoconus | Device: Intacs | Not Applicable |
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.
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 : | December 31, 2022 |
Estimated Study Completion Date : | January 31, 2023 |

Arm | Intervention/treatment |
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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.
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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. |
- 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.
- 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.
- 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.
- 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.
- 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 |
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).

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
Contact: Peter Chen, PhD | 214-648-3837 | Peter.Chen@UTSouthwestern.edu | |
Contact: Bonnie Miller, PhD | 214-648-3826 | Bonnie.Miller@UTSouthwestern.edu |
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 |
Principal Investigator: | Steven Verity, MD | UTSW Medical Center at Dallas |
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: | October 4, 2022 |
Last Verified: | September 2022 |
Cornea Keratoconus Steep cornea |
Keratoconus Corneal Diseases Eye Diseases |