Intacs Inserts for Keratoconus

Overseen By Asha Varghese, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Must not be taking: Accutane, Cordarone

Disqualifiers: Thin corneas, Autoimmune disease, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 9

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Intacs, a small device placed in the eye to assist individuals with keratoconus, a condition causing the cornea to bulge into a cone shape. The goal is to improve vision and potentially avoid a corneal transplant. Suitable candidates have worsening vision not corrected by glasses or contacts and have been advised that a corneal transplant is their only option. Participants should have a clear central cornea and a minimum corneal thickness at the surgical site. As an unphased trial, this study provides a unique opportunity for patients to explore an alternative to corneal transplant surgery.

Will I have to stop taking my current medications?

If you are taking isotretinoin (Accutane) or amiodarone HCL (Cordarone), you will need to stop these medications to participate in the trial.

What prior data suggests that the Intacs device is safe for treating keratoconus?

Research has shown that Intacs inserts, used to treat keratoconus, are generally safe for patients. The FDA first approved these inserts to correct mild nearsightedness and later for keratoconus. Studies indicate that most patients experience improved vision after the procedure. For instance, one study found that 72% of treated eyes improved by two or more lines on an eye chart, indicating a clear improvement in vision.

Although some patients might not notice changes, serious side effects are rare. Overall, Intacs is considered a safe and effective option for improving vision in people with keratoconus. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Intacs Inserts are unique because they offer a non-invasive option for managing keratoconus, potentially delaying the need for a corneal transplant. Unlike standard treatments like rigid gas permeable lenses or corneal cross-linking, Intacs are tiny plastic inserts placed into the cornea to reshape it, reducing myopia and astigmatism. Researchers are excited because this approach can restore functional vision without the more invasive surgical procedures often required in advanced cases.

What evidence suggests that Intacs inserts are effective for keratoconus?

Research has shown that Intacs inserts, which participants in this trial will receive, effectively treat keratoconus, a condition affecting the eye. These inserts can improve vision and maintain the cornea, the clear front part of the eye, in a stable shape. One study found that Intacs enhanced vision clarity and reduced corneal irregularities over five years. Other data indicate that many patients notice improved vision within one to two years after receiving Intacs. Overall, Intacs inserts offer a promising option for managing keratoconus and may help delay the need for a corneal transplant. ^{1 3 4 6 7}

Who Is on the Research Team?

Steven M Verity, MD

Principal Investigator

UTSW Medical Center at Dallas

Are You a Good Fit for This Trial?

This trial is for adults over 21 with keratoconus, a condition that distorts the cornea. It's for those whose vision isn't helped enough by glasses or contacts and who have thick enough corneas (450 microns or more) at the incision site. People with very thin corneas, autoimmune diseases, pregnancy, certain eye conditions, or taking specific medications can't join.

Inclusion Criteria

My vision has worsened to the point where glasses or contacts no longer help me see well enough for daily tasks.

My only option to see better is through corneal transplantation.

My cornea is thick enough for the surgery.

Exclusion Criteria

My cornea is thinner than usual, measuring 449 microns or less.

Pregnant or nursing patients

Patients with collagen vascular, autoimmune or immunodeficiency disease

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-Operative Assessment

Pre-OR visit includes Visual Acuity, Refraction, Topography, Keratometry, Glare Test, Mesopic Pupil Size, Pachymetry, Tonometry, Slit Lamp Exam, and Contrast Sensitivity

1.5 hours

1 visit (in-person)

Surgery

INTACS inserts are surgically placed into the cornea

30 minutes

1 visit (in-person)

Post-Operative Follow-up

Post-OR visits at Day 1, 1 week, 1 month, 3 months, 6 months, and 12 months to monitor Visual Acuity, Refraction, Topography, Tonometry, and Slit Lamp Exam

12 months

6 visits (in-person)

Long-term Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Intacs

Trial Overview

The trial tests INTACS prescription inserts made of PMMA material to treat keratoconus. These clear segments are implanted into the eye in varying thicknesses based on individual needs to improve vision without needing a full corneal transplant.

How Is the Trial Designed?

Group I: Intacs Device Experimental Treatment 1 Intervention

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.

Intacs is already approved in United States for the following indications:

Approved in United States as Intacs for:

• Keratoconus
• Low levels of nearsightedness (-1.00 to -3.00 diopters)

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Published Research Related to This Trial

The modified intracorneal ring segment (INTACS) implantation significantly improved uncorrected visual acuity (UCVA) and best spectacle corrected visual acuity (BSCVA) in patients with moderate to advanced keratoconus, with improvements noted at both 6 and 12 months post-surgery.

Despite the efficacy in vision improvement, the procedure had notable safety concerns, with 30% of eyes experiencing complications such as ring exposure due to corneal thinning and one case of anterior chamber perforation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modified intracorneal ring segment implantations (INTACS) for the management of moderate to advanced keratoconus: efficacy and complications. Kanellopoulos, AJ., Pe, LH., Perry, HD., et al.[2022]

The implantation of Intacs SK corneal ring segments in 24 eyes of patients with moderate to severe keratoconus resulted in significant improvements in uncorrected and corrected distance visual acuity after 6 months, indicating its efficacy as a treatment option.

The procedure was found to be safe, with no complications reported, and it led to a notable reduction in myopia and astigmatism, particularly in eyes with steeper preoperative corneal curvature.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intrastromal corneal ring segment SK for moderate to severe keratoconus: a case series. Fahd, DC., Jabbur, NS., Awwad, ST.[2012]

In a study of 37 eyes from 36 patients with moderate to severe keratoconus, the Intacs SK corneal ring segment implant significantly improved both uncorrected and best-corrected distance visual acuity after surgery, indicating its efficacy as a treatment option.

The procedure was found to be safe, with no significant changes in central corneal thickness post-operation, and a notable reduction in average keratometry measurements, suggesting improved corneal shape.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of moderate to severe keratoconus with 6-mm Intacs SK. Niknam, S., Shamshiri, M., Shahrzad, SS., et al.[2022]

In a study of 10 patients with keratoconus, INTACS micro-thin inserts significantly improved uncorrected visual acuity from a preoperative average of approximately 20/200 to about 20/50 after 12 months, indicating effective treatment for contact lens intolerant patients.

The procedure was safe, with no intraoperative complications, and it successfully reduced corneal steepening and astigmatism, improving the overall corneal shape and visual acuity in nearly all participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

INTACS inserts for treating keratoconus: one-year results. Colin, J., Cochener, B., Savary, G., et al.[2022]

In a study involving 14 eyes with advanced keratoconus, INTACS implantation significantly improved uncorrected visual acuity and best spectacle-corrected visual acuity after 6 months, indicating its efficacy as a treatment option.

The procedure demonstrated 100% safety with no major complications, and over 60% of patients were able to tolerate contact lenses post-surgery, suggesting it is a reliable intervention for managing advanced keratoconus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intacs in advanced keratoconus. Shetty, R., Kurian, M., Anand, D., et al.[2022]

In a study of 306 keratoconic eyes, Intacs implantation significantly improved best corrected visual acuity (BCVA) in 71.6% of cases and uncorrected visual acuity (UCVA) in 75.7% after an average follow-up of about 10 months.

The treatment was effective across all stages of keratoconus, although patients with more severe keratoconus (stage IV) experienced less improvement in UCVA compared to those with moderate keratoconus (stage II).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intacs implantation using a femtosecond laser for management of keratoconus: Comparison of 306 cases in different stages. Ertan, A., Kamburoğlu, G.[2022]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3959038/

Intrastromal Corneal Ring Segments: How Successful is the ...

This review evaluates the outcomes of intrastromal corneal ring segment (ICRS) implantation for the treatment of keratoconus considering a new grading system.

2.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf4/h040002b.pdf

Intrastromal Corneal Ring Segments (ICRS®)

INTACS® prescription inserts are intended for the reduction or elimination of myopia and astigmatism in patients with keratoconus, who are no longer able to ...

3.

nature.com

nature.com/articles/s41598-018-36668-7

Long-term outcome of intrastromal corneal ring segments ...

ICRS has advantages in improving CDVA with topographic stabilization and decreasing coma in keratoconus for five years.

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0161642001006467

INTACS inserts for treating keratoconus: One-year results

INTACS micro-thin prescription inserts seem to provide a viable method for treating clear corneal keratoconus for patients who are contact lens intolerant. The ...

5.

employer.myhealthtoolkitbsa.com

employer.myhealthtoolkitbsa.com/web/public/brands/medicalpolicyhb/external-policies/implantation-of-intrastromal-corneal-ring-segments/

Implantation of Intrastromal Corneal Ring Segments

These series have generally reported that a substantial proportion of patients with keratoconus treated with this device have improved vision at 1 to 2 years of ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12446827/

Intrastromal corneal ring segments for keratoconus

We reviewed clinical studies, case reports, and long-term follow-ups to compare visual outcomes, corneal stability, and safety profiles of these ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8221670/

Clinical outcomes after intracorneal ring segment implantation ...

The implantation of intracorneal ring segments represents an effective and safe therapeutic option for visual improvement in patients with keratoconus.