INTACS (Intrastromal Corneal Ring Segments) For Corneal Ectasia (INTACS)
Primary Purpose
Keratoconus
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
INTACS
Sponsored by
About this trial
This is an interventional treatment trial for Keratoconus
Eligibility Criteria
Inclusion Criteria:
- 21 years of age, or older
- have experienced a progressive deterioration in their vision, such that they can no longer achieve adequate functional vision on a daily basis with contact lenses, or spectacles.
- have clear central corneas
- have a corneal thickness of 450 microns or greater at the proposed incision site
- have corneal transplantation as the only remaining option to improve their visual function
Exclusion Criteria:
- under 21 years of age
- have not experienced a progressive deterioration in their vision, such that they can no longer achieve adequate functional vision on a daily basis with contact lenses, or spectacles.
- do not have clear central corneas
- do not have a corneal thickness of 450 microns or greater at the proposed incision site
- do not have corneal transplantation as the only remaining option to improve their visual function
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Keratoconus
Arm Description
Outcomes
Primary Outcome Measures
Corneal mapping to measure corneal thickness and steepening
Corneal Topography
Secondary Outcome Measures
Full Information
NCT ID
NCT02512432
First Posted
July 29, 2015
Last Updated
June 2, 2023
Sponsor
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT02512432
Brief Title
INTACS (Intrastromal Corneal Ring Segments) For Corneal Ectasia
Acronym
INTACS
Official Title
INTACS (Intrastromal Corneal Ring Segments) For Corneal Ectasia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
June 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To join established study put on by Addition Technologies, Inc. in the surgical implantation of asymmetrical INTACS segments to treat myopia and astigmatism in patients with keratoconus.
Detailed Description
Use of asymmetrical corneal inserts to reduce or eliminate myopia and astigmatism in patients with keratoconus, who are no longer able to achieve adequate vision with their contact lenses or spectacles, so that their functional vision may be restored and the need for corneal transplantation may potentially be deferred.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Keratoconus
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
INTACS
Intervention Description
asymmetrical corneal inserts to reduce, or eliminate myopia and astigmatism in patients with keratoconus to decrease dependence on contact lenses and spectacle correction, while potentially deferring need for corneal transplantation.
Primary Outcome Measure Information:
Title
Corneal mapping to measure corneal thickness and steepening
Description
Corneal Topography
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
21 years of age, or older
have experienced a progressive deterioration in their vision, such that they can no longer achieve adequate functional vision on a daily basis with contact lenses, or spectacles.
have clear central corneas
have a corneal thickness of 450 microns or greater at the proposed incision site
have corneal transplantation as the only remaining option to improve their visual function
Exclusion Criteria:
under 21 years of age
have not experienced a progressive deterioration in their vision, such that they can no longer achieve adequate functional vision on a daily basis with contact lenses, or spectacles.
do not have clear central corneas
do not have a corneal thickness of 450 microns or greater at the proposed incision site
do not have corneal transplantation as the only remaining option to improve their visual function
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Onnie Parker
Phone
8588224848
Email
oparker@ucsd.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Heichel, MD
Organizational Affiliation
University of California, San Diego, Shiley Eye Institute
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
INTACS (Intrastromal Corneal Ring Segments) For Corneal Ectasia
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