Artificial Iris Implant for Aniridia

Recruiting at 3 trial locations

Overseen By Barbara Fant

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Clinical Research Consultants, Inc.

Must not be taking: Fluoroquinolones, Steroids

Disqualifiers: Uveitis, Glaucoma, Diabetes, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 month

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the long-term safety and effectiveness of an artificial iris implant for individuals with missing or defective irises, which can cause light sensitivity and glare. The CustomFlex Artificial Iris Prosthesis aims to improve vision and reduce discomfort from bright lights. It is open to individuals experiencing symptoms like light sensitivity or glare due to a partial or full iris defect. Participants should have conditions such as cataracts but must not have uncontrolled eye inflammation or certain other eye conditions. As an unphased trial, this study offers participants a unique opportunity to potentially improve their vision and quality of life.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have a known sensitivity to the required postoperative medications and no alternative is available, you may be excluded from the study.

What prior data suggests that the CustomFlex Artificial Iris Prosthesis is safe for treating iris defects?

Research has shown that the CustomFlex Artificial Iris Prosthesis is safe for use. Studies have found it effective in treating issues caused by missing or damaged irises. The U.S. Food and Drug Administration (FDA) has approved it for this purpose.

In earlier studies, patients with iris defects from injury or disease received the implant and reported no major safety issues. Common side effects, if any, were mild and manageable.

Overall, the treatment has been well-received, and the FDA's approval confirms its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The CustomFlex Artificial Iris Prosthesis is unique because it offers a customizable solution for individuals with aniridia, a condition where the iris is missing or incomplete. Unlike traditional treatments that primarily focus on cosmetic lenses or surgical reconstruction, this prosthesis is surgically implanted to closely mimic the appearance and function of a natural iris. Researchers are excited about this treatment because it not only improves the aesthetic appearance of the eye but also enhances light regulation and visual comfort, potentially leading to better overall vision quality for patients.

What evidence suggests that the CustomFlex Artificial Iris Prosthesis is effective for treating iris defects?

Research has shown that the CustomFlex Artificial Iris Prosthesis effectively treats symptoms of iris defects, such as aniridia. Studies have found that this device addresses both practical issues, like sensitivity to light, and appearance concerns. Testing has confirmed its safety and effectiveness for people of all ages, including children and adults. The FDA has confirmed its benefits, noting that it enhances patients' quality of life by giving the eye a more natural look. This artificial iris offers a reliable option for those with congenital or acquired iris problems. Participants in this trial may enroll in one of various treatment arms, including the Compassionate Use Cohort, PMA Cohort, or Continued Access Cohort, depending on their eligibility. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for adults and children with congenital or acquired iris defects causing light sensitivity, photophobia, or glare. Candidates must be over 22 years old, pseudophakic, aphakic or need cataract extraction. Previous participants of the AI-001 IDE study are also eligible. Exclusions include uncontrolled eye inflammation, severe eye conditions like chronic uveitis or glaucoma, pregnant/lactating women, and those sensitive to post-op medications.

Exclusion Criteria

I do not have any eye conditions or health issues that would interfere with the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

The artificial iris is implanted in the eye with an iris defect. The fellow eye can be treated 1 month after the primary eye.

1 month

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of vision quality and participant satisfaction.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• CustomFlex Artificial Iris Prosthesis

Trial Overview The CustomFlex Artificial Iris prosthesis is being tested for long-term safety and effectiveness in treating iris defects. The study includes individuals who have previously participated in a related trial as well as new pediatric cases between the ages of 3 and under 22.

How Is the Trial Designed?

Group I: PMA Cohort Experimental Treatment 1 Intervention

Study participants that meet the inclusion/exclusion criteria for the study may be enrolled in the compassionate use treatment arm. The artificial iris will be implanted in the eye with an iris defect. The fellow eye can be treated 1 month after the primary eye.

Group II: Continued Access Cohort Experimental Treatment 1 Intervention

Study participants that meet the inclusion/exclusion criteria for the study may be enrolled in the Continued Access cohort, after enrollment in the PMA cohort is complete.The fellow eye can be treated 1 month after the primary eye.

Group III: Compassionate Use Cohort Experimental Treatment 1 Intervention

Study participants that do not meet the inclusion/exclusion criteria for the study may be enrolled in the compassionate use treatment arm. The artificial iris will be implanted in the eye with an iris defect. The fellow eye can be treated 1 month after the primary eye.

CustomFlex Artificial Iris Prosthesis is already approved in United States, European Union for the following indications:

Approved in United States as CustomFlex Artificial Iris Prosthesis for:

• Full or partial aniridia resulting from congenital aniridia, acquired defects, or other conditions associated with full or partial aniridia

Approved in European Union as CustomFlex Artificial Iris for:

• Full or partial aniridia resulting from congenital aniridia, acquired defects, or other conditions associated with full or partial aniridia

Who Is Running the Clinical Trial?

Clinical Research Consultants, Inc.

Lead Sponsor

Trials

7

Recruited

1,400+

HumanOptics AG

Industry Sponsor

Trials

1

Recruited

500+

Published Research Related to This Trial

In a study involving nine patients with various types of iris deficiencies, 90% of the eyes showed improved best-corrected visual acuity after surgical implantation of prosthetic iris devices, indicating high efficacy.

The procedure was found to be safe, with only mild postoperative complications such as anterior uveitis in four eyes, and no cases of secondary glaucoma reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical management of iris defects with prosthetic iris devices. Mavrikakis, I., Mavrikakis, E., Syam, PP., et al.[2019]

The CustomFlex Artificial Iris significantly reduced light sensitivity and glare in patients with iris defects, with a 59.7% reduction in daytime light sensitivity and a 53.1% reduction in daytime glare after 12 months, indicating its efficacy in improving visual comfort.

The device demonstrated a high safety profile, with no significant loss of corrected distance visual acuity and only a median endothelial cell density loss of 7.2% at 12 months, while 93.8% of patients reported improved cosmetic appearance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of the United States Food and Drug Administration Clinical Trial of the CustomFlex Artificial Iris. Ayres, BD., Fant, BS., Landis, ZC., et al.[2022]

The first case of a sutureless artificial iris prosthesis was successfully used in a 15-year-old girl with congenital aniridia and cataracts, leading to significant improvements in visual comfort and cosmetic appearance after surgery.

At the 1-year follow-up, the patient reported reduced glare and photophobia, with no postoperative complications, highlighting the safety and efficacy of the ArtificialIris device in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sutureless artificial iris after phacoemulsification in congenital aniridia. Fernández-López, E., Pascual, FP., Pérez-López, M., et al.[2018]

The customized silicone flexible artificial iris significantly improved subjective photophobia and cosmetic appearance in patients with iris deficiencies, with scores improving by 5.2 and 4.7 points respectively on a 0 to 10 scale after three months.

While the artificial iris showed promising cosmetic results, it is not recommended for patients with pre-existing glaucoma due to a 35.7% incidence of elevated intraocular pressure and potential complications like chronic inflammation that may require removal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flexible silicone artificial iris in cases of aniridia and iris deficiencies. Roman, S., Baudouin, C.[2021]

In a study of 50 patients with congenital aniridia, 96 eyes received a custom-made iris prosthetic device, resulting in a significant reduction of photophobia in 95.7% of cases and glare in 95.2% of cases, demonstrating its effectiveness.

The custom iris prosthesis was found to be safe, with a low incidence of aniridia fibrosis syndrome (3.1%), indicating that it does not increase the risk of this complication compared to previous studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term follow-up of a custom-made prosthetic iris device in patients with congenital aniridia. Figueiredo, GB., Snyder, ME.[2021]

In a study of 34 patients with aniridia who received a custom-made artificial iris, the prosthesis demonstrated long-term stability and improved visual function, with no need for repositioning after implantation.

Complications such as glaucoma and darkening of iris tissue were more common in patients with the embedded fiber mesh in their implants, suggesting that using artificial irises without this mesh may reduce these risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term results after artificial iris implantation in patients with aniridia. Rickmann, A., Szurman, P., Januschowski, K., et al.[2022]

Prosthetic iris devices can effectively treat aniridia while also addressing related issues like aphakia or cataracts, but none are currently approved for use in the USA.

The CustomFlex iris prosthesis from HumanOptics shows promising cosmetic results and is being evaluated in a multicenter clinical trial, highlighting the importance of surgical planning for safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of aniridia and iris defects: an update on iris prosthesis options. Weissbart, SB., Ayres, BD.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35131359/

Results of the United States Food and Drug Administration ... The device is safe and effective for the treatment of symptoms and an unacceptable cosmetic appearance created by congenital or acquired iris defects.

2. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf17/P170039d.pdf

CustomFlex™ Artificial Iris Professional Use Information Results for the key safety and effectiveness endpoints and other study outcomes were similar in the pediatric eyes, adult eyes, and the overall study population ...

3. humanoptics.com humanoptics.com/en/physicians/artificialiris/

The ARTIFICIALIRIS for your patients with aniridia The CUSTOMFLEX® ARTIFICIALIRIS is a unique treatment option of its kind for patients with aniridia. The aesthetic rehabilitation with the custom-made iris ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT01860612

Safety and Effectiveness of the CustomFlex Artificial Iris ... The purpose of this study is to study the long term safety and effectiveness of an artificial iris prosthesis for the treatment of iris ...

5. provider.healthybluenc.com provider.healthybluenc.com/medpolicies/healthybluenc/active/mp_pw_e000641.html

SURG.00156 Implanted Artificial Iris Devices Figueiredo and Snyder (2020) evaluated the effectiveness and safety of the CustomFlex device when used to treat photic symptoms in individuals with congenital ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf17/P170039b.pdf

summary of safety and effectiveness data (ssed) Seventeen (17) eyes of 17 patients received the CustomFlex™ Artificial Iris device for acquired iris defects resulting from trauma (N=15), HSV ...