KeratoconusINTACSNCT02512432
INTACS (Intrastromal Corneal Ring Segments) For Corneal Ectasia
A study testing INTACS in people with Keratoconus, run by University of California, San Diego.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Keratoconus
- What is being tested?
- INTACS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Dec 2025to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Keratoconus
- Being tested
- INTACS
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INTACSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Keratoconus | Other | Not described Receives: Device: INTACS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal mapping to measure corneal thickness and steepening
Corneal Topography
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Study startDec 2025 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Heichel, MD, University of California, San Diego
- Investigators
- Christopher Heichel, MD, Principal investigator, University of California, San Diego, Shiley Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02512432
- Sponsor's protocol ID
- 150826
- Acronym
- INTACS
- Status last verified
- May 2024
- First submitted
- 29 Jul 2015
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INTACS (Intrastromal Corneal Ring Segments) For Corneal Ectasia
- ClinicalTrials.gov ID
- NCT02512432
- Acronym / sponsor ID
- INTACS / 150826
- Conditions
- Keratoconus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 30 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Keratoconus | Other | Device: INTACS |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INTACSasymmetrical 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. | Device | Keratoconus |
Primary outcome
Corneal mapping to measure corneal thickness and steepening
Time frame: 1 year
Corneal Topography
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher Heichel, MD principal investigator
University of California, San Diego, Shiley Eye Institute
Questions about this trial
What is this clinical trial studying?
A study testing INTACS in people with Keratoconus, run by University of California, San Diego.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Onnie Parker (8588224848, oparker@ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal mapping to measure corneal thickness and steepening (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.