KeratoconusNCT02138669
Intacs Prescription Inserts for Keratoconus Patients
A study testing Intacs in people with Keratoconus, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to 31 Jul 2030
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UTSW Medical Center at Dallas
Dallas, Texas, 75390
Boris Patlis, MS, 214-645-2015, Boris.Patlis@UTSouthwestern.edu
Steven Verity, MD
About this study
Official title: INTACS® Prescription Inserts Used to Treat Patients With Keratoconus as a Humanitarian Use Device
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.
Read the 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.
- Conditions
- Keratoconus
- Being tested
- Intacs
- Keywords
- Cornea, Keratoconus, Steep cornea
- Medical subject headings
- Keratoconus, Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntacsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intacs Device | Other | 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. Receives: Device: Intacs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 Months
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.
Measured: 12 Months
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.
Measured: 12 Months
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.
Measured: 12 Months
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.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2014 (estimated)
- Study startJan 2011
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Jul 2030 (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 Texas Southwestern Medical CenterThe 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Verity, University of Texas Southwestern Medical Center
- Investigators
- Steven Verity, MD, Principal investigator, UTSW Medical Center at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02138669
- Sponsor's protocol ID
- STU 012011-115
- Other IDs
- Intacs_Prospective
- Status last verified
- Apr 2026
- First submitted
- 5 May 2014
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INTACS® Prescription Inserts Used to Treat Patients With Keratoconus as a Humanitarian Use Device
- ClinicalTrials.gov ID
- NCT02138669
- Acronym / sponsor ID
- STU 012011-115
- Conditions
- Keratoconus
- Keywords
- Cornea, Keratoconus, Steep cornea
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 14 May 2014 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intacs Device | Other | Device: IntacsINTACS® 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
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 |
|---|---|---|
| IntacsINTACS® 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 Device |
Primary outcome
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.
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 9 Apr 2026.
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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.
Steven Verity, MD principal investigator
UTSW Medical Center at Dallas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intacs in people with Keratoconus, run by University of Texas Southwestern Medical Center at 1 site in United States.
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 1 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: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Peter Chen, PhD (214-648-3837, Peter.Chen@UTSouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of INTACS prescription inserts to reduce astigmatism due to Keratoconus as determined by refraction assessment. (time frame: 12 Months). The study lists 5 primary outcomes in all. 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 9 Apr 2026.