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Intacs Prescription Inserts for Keratoconus Patients

Primary Purpose

Keratoconus

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intacs
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus focused on measuring Cornea, Keratoconus, Steep cornea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • UTSW Medical Center at DallasRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Intacs Device

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 5, 2014
Last Updated
April 21, 2023
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02138669
Brief Title
Intacs Prescription Inserts for Keratoconus Patients
Official Title
INTACS® Prescription Inserts Used to Treat Patients With Keratoconus as a Humanitarian Use Device
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus
Keywords
Cornea, Keratoconus, Steep cornea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intacs Device
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Intacs
Intervention Description
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 Information:
Title
Efficacy of INTACS prescription inserts to reduce astigmatism due to Keratoconus as determined by refraction assessment.
Description
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.
Time Frame
12 Months
Title
Efficacy of INTACS prescription inserts to reduce astigmatism due to Keratoconus as determined by visual acuity examination.
Description
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.
Time Frame
12 Months
Title
Efficacy of INTACS prescription inserts to reduce other corneal aberrations due to Keratoconus as determined by corneal topography assessment.
Description
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.
Time Frame
12 Months
Title
Efficacy of INTACS prescription inserts to reduce other corneal aberrations due to Keratoconus as determined by tonometry assessment.
Description
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.
Time Frame
12 Months
Title
Efficacy of INTACS prescription inserts to reduce other corneal aberrations due to Keratoconus as determined by slit lamp corneal examination.
Description
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.
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Chen, PhD
Phone
214-648-3837
Email
Peter.Chen@UTSouthwestern.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Bonnie Miller, PhD
Phone
214-648-3826
Email
Bonnie.Miller@UTSouthwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Verity, MD
Organizational Affiliation
UTSW Medical Center at Dallas
Official's Role
Principal Investigator
Facility Information:
Facility Name
UTSW Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boris Patlis, BS
Phone
214-645-2015
Email
Boris.Patlis@UTSouthwestern.edu
First Name & Middle Initial & Last Name & Degree
Yesenia Leach, BA
Phone
214-645-2014
Email
Yesenia.Leach@UTSouthwestern.edu
First Name & Middle Initial & Last Name & Degree
Steven Verity, MD

12. IPD Sharing Statement

Learn more about this trial

Intacs Prescription Inserts for Keratoconus Patients

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