KeratoconusNCT04895514
Gamma-Irradiated Corneal Inlay for Keratoconus
A study testing Gamma-irradiated corneal tissue inlay in people with Keratoconus, run by Cornea and Laser Eye Institute at 1 site in United States.
Trial summary
Study objective is to evaluate the outcomes of placing gamma-irradiated corneal tissue (VisionGraft, CorneaGen, USA) within the cornea of patients with keratoconus, a procedure called Corneal Tissue Addition for Keratoconus (CTAK). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Keratoconus
- What is being tested?
- Gamma-irradiated corneal tissue inlay
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years of age, male or female, of any race
- Provide written consent and sign a HIPAA form
- Willingness and ability to follow all instructions and comply with schedule for follow-up visits
- For females: must not be pregnant
- Having topographic evidence of keratoconus which is graded as moderate or severe keratoconus defined as the following:
- Moderate Keratoconus: Axial topography consistent with keratoconus, Maximum keratometry on Pentacam greater than or equal to 51.01 D
Show all 10Show fewer
- Severe Keratoconus: Axial topography consistent with keratoconus with marked areas of steepening, Maximum keratometry on Pentacam greater than or equal to 56.01 D
- Presence of central or inferior steepening on the Pentacam map
- BSCVA less than or equal to 20/25
- Contact lens wearers only: remove contact lenses one week prior to the screening refraction
Who cannot join
- Contraindications, sensitivity or known allergy to the use of the test article(s) or their components
- If female, be pregnant
- Eyes classified as either normal, atypical normal, keratoconus suspect or mild keratoconus on the severity grading scheme
- Previous ocular condition (other than refractive error) in the eye to be treated that may predispose the eye for future complications. For example:
- History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, corneal melt, corneal dystrophy, etc.)
- A history of delayed epithelial healing in the eye to be treated
- Have used an investigational drug or device within 30 days of the study or be concurrently enrolled in another investigational drug or device study within 30 days of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Cornea and Laser Eye Institute, Hersh Vision Group
Teaneck, New Jersey, 07666
About this study
Official title: Use of Gamma-Irradiated Preserved Corneal Tissue to Treat Keratoconus
Study objective is to evaluate the outcomes of placing gamma-irradiated corneal tissue (VisionGraft, CorneaGen, USA) within the cornea of patients with keratoconus, a procedure called Corneal Tissue Addition for Keratoconus (CTAK).
Read the detailed description
Using E gamma irradiated sterilized preserved corneal tissue, shaped corneal tissue inlays are placed in a keratoconic cornea. Preserved corneal tissue is currently available commercially from CorneaGen (VisionGraft,1200 6th Ave., STe.300, Seattle, WA 98101). Such tissue is currently used in a number of eye surgical procedures. It is considered suitable for corneal surgical procedures that do not require viable corneal endothelium, as is the case for a tissue enhancement procedure in keratoconus. The goal of the current protocol to evaluate the outcomes of placing gamma-irradiated preserved tissue within the keratoconic cornea in order to enhance corneal thickness, stability, and optical conformation.
- Conditions
- Keratoconus
- Being tested
- Gamma-irradiated corneal tissue inlay
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamma-irradiated corneal tissue inlayProcedure or surgery
A mid-stomal pocket will be made into the cornea with a femtosecond laser (Intralase). A small disc of gamma-irradiated preserved corneal tissue will then be placed into the pocket
| Study group | Role | What they receive |
|---|---|---|
| Corneal tissue inlay | Experimental | The treated cornea will be implanted with a thin disc of gamma-irradiated preserved corneal tissue Receives: Procedure: Gamma-irradiated corneal tissue inlay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gamma-Irradiated Preserved Corneal Tissue Inlay
Change in mean keratometry on corneal topography
Measured: 6 months
Secondary outcomes (4)
Gamma Irradiated Preserved Corneal Tissue Inlay
Inferior-Superior (I-S) ratio
Measured: 6 months
Gamma Irradiated Preserved Corneal Tissue Inlay
Manifest refraction
Measured: 6 months
Gamma Irradiated Preserved Corneal Tissue Inlay
Uncorrected distance visual acuity
Measured: 6 months
Gamma Irradiated Preserved Corneal Tissue Inlay
Best spectacle corrected distance visual acuity
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start1 Feb 2021
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Nov 2023 (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.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cornea and Laser Eye Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter S Hersh, MD, Principal investigator, Cornea and Laser Eye InstituteSteven A Greenstein, MD, Principal investigator, Cornea and Laser Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04895514
- Sponsor's protocol ID
- GAMMA TISSUE INLAY
- Status last verified
- Nov 2022
- First submitted
- 17 May 2021
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Gamma-Irradiated Preserved Corneal Tissue to Treat Keratoconus
- ClinicalTrials.gov ID
- NCT04895514
- Acronym / sponsor ID
- GAMMA TISSUE INLAY
- Conditions
- Keratoconus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cornea and Laser Eye InstituteUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 20 May 2021 (actual)
- 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.
Study objective is to evaluate the outcomes of placing gamma-irradiated corneal tissue (VisionGraft, CorneaGen, USA) within the cornea of patients with keratoconus, a procedure called Corneal Tissue Addition for Keratoconus (CTAK).
Detailed description
Using E gamma irradiated sterilized preserved corneal tissue, shaped corneal tissue inlays are placed in a keratoconic cornea. Preserved corneal tissue is currently available commercially from CorneaGen (VisionGraft,1200 6th Ave., STe.300, Seattle, WA 98101). Such tissue is currently used in a number of eye surgical procedures. It is considered suitable for corneal surgical procedures that do not require viable corneal endothelium, as is the case for a tissue enhancement procedure in keratoconus. The goal of the current protocol to evaluate the outcomes of placing gamma-irradiated preserved tissue within the keratoconic cornea in order to enhance corneal thickness, stability, and optical conformation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Corneal tissue inlay | Experimental | Procedure: Gamma-irradiated corneal tissue inlayThe treated cornea will be implanted with a thin disc of gamma-irradiated preserved corneal tissue |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- At least 18 years of age, male or female, of any race
- Provide written consent and sign a HIPAA form
- Willingness and ability to follow all instructions and comply with schedule for follow-up visits
- For females: must not be pregnant
- Having topographic evidence of keratoconus which is graded as moderate or severe keratoconus defined as the following:
Key exclusion criteria (7 listed)
- Contraindications, sensitivity or known allergy to the use of the test article(s) or their components
- If female, be pregnant
- Eyes classified as either normal, atypical normal, keratoconus suspect or mild keratoconus on the severity grading scheme
- Previous ocular condition (other than refractive error) in the eye to be treated that may predispose the eye for future complications. For example:
- A history of delayed epithelial healing in the eye to be treated
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 |
|---|---|---|
| Gamma-irradiated corneal tissue inlayA mid-stomal pocket will be made into the cornea with a femtosecond laser (Intralase). A small disc of gamma-irradiated preserved corneal tissue will then be placed into the pocket | Procedure or surgery | Corneal tissue inlay |
Primary outcome
Gamma-Irradiated Preserved Corneal Tissue Inlay
Time frame: 6 months
Change in mean keratometry on corneal topography
4 secondary outcomes
Gamma Irradiated Preserved Corneal Tissue Inlay
Time frame: 6 months
Gamma Irradiated Preserved Corneal Tissue Inlay
Time frame: 6 months
Gamma Irradiated Preserved Corneal Tissue Inlay
Time frame: 6 months
Gamma Irradiated Preserved Corneal Tissue Inlay
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
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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. This study is not recruiting at the moment.
Peter S Hersh, MD principal investigator
Cornea and Laser Eye Institute
Steven A Greenstein, MD principal investigator
Cornea and Laser Eye Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gamma-irradiated corneal tissue inlay in people with Keratoconus, run by Cornea and Laser Eye Institute 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 10 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 14 Nov 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gamma-Irradiated Preserved Corneal Tissue Inlay (time frame: 6 months). 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 14 Nov 2022.