KeratoconusNCT02649738
Corneal Tissue Inlay for Keratoconus
A study testing Corneal tissue inlay in people with Keratoconus, run by Cornea and Laser Eye Institute at 1 site in United States.
Trial summary
This study will evaluate the outcomes of placing preserved corneal tissue within the keratoconic cornea in order to enhance thickness, stability, and optical conformation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratoconus
- What is being tested?
- Corneal tissue inlay
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Dec 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be at least 18 years of age, male or female, of any race
- Provide written informed 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.
Who cannot join
- Contraindications, sensitivity or known allergy to the use of the test article(s) or their components
- If female, 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 corneal disease (e.g., herpes simplex, herpes zoster keratitis, corneal melt, corneal dystrophy, etc.)
- A history of delayed corneal healing in the eye to be treated
- Have used an investigational drug or device within 30 days of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Cornea and Laser Eye Institue - Hersh Vision Group
Teaneck, New Jersey, 07666
About this study
Official title: Use of Preserved Corneal Tissue Inlay to Treat Keratoconus
This study will evaluate the outcomes of placing preserved corneal tissue within the keratoconic cornea in order to enhance thickness, stability, and optical conformation.
Read the detailed description
The objective of this study is to evaluate the outcomes of placing preserved corneal tissue within the corneal stroma in keratoconus patients as a means of enhancing thickness, stability, and optical conformation.
- Conditions
- Keratoconus
- Being tested
- Corneal tissue inlay
- Keywords
- keratoconus, 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.
Corneal tissue inlayProcedure or surgery
A mid-stomal pocket will be made into the cornea with a femtosecond laser (Intralase). A small disc of 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 preserved corneal tissue Receives: Procedure: Corneal tissue inlay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal tissue inlay for keratoconus
Change in maximum keratometry on corneal topography
Measured: 6 months
Corneal tissue inlay for keratoconus
Uncorrected visual acuity
Measured: 6 months
Corneal tissue inlay for keratoconus
Best spectacle corrected 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 posted7 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cornea and Laser Eye Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Hersh, MD, Principal investigator, Cornea and Laser Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02649738
- Sponsor's protocol ID
- CLEI-Tissue-Inlay
- Status last verified
- Dec 2022
- First submitted
- 6 Jan 2016
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Greenstein SA, Yu AS, Gelles JD, Eshraghi H, Hersh PS. Corneal tissue addition keratoplasty: new intrastromal inlay procedure for keratoconus using femtosecond laser-shaped preserved corneal tissue. J Cataract Refract Surg. 2023 Jul 1;49(7):740-746. doi: 10.1097/j.jcrs.0000000000001187.
PubMed 36943309
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Preserved Corneal Tissue Inlay to Treat Keratoconus
- ClinicalTrials.gov ID
- NCT02649738
- Acronym / sponsor ID
- CLEI-Tissue-Inlay
- Conditions
- Keratoconus
- Keywords
- keratoconus, corneal tissue inlay
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cornea and Laser Eye InstituteUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 7 Jan 2016 (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.
This study will evaluate the outcomes of placing preserved corneal tissue within the keratoconic cornea in order to enhance thickness, stability, and optical conformation.
Detailed description
The objective of this study is to evaluate the outcomes of placing preserved corneal tissue within the corneal stroma in keratoconus patients as a means of enhancing 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: Corneal tissue inlayThe treated cornea will be implanted with a thin disc of preserved corneal tissue |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be at least 18 years of age, male or female, of any race
- Provide written informed 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.
Key exclusion criteria (6 listed)
- Contraindications, sensitivity or known allergy to the use of the test article(s) or their components
- If female, 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 corneal disease (e.g., herpes simplex, herpes zoster keratitis, corneal melt, corneal dystrophy, etc.)
- A history of delayed corneal 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 |
|---|---|---|
| Corneal tissue inlayA mid-stomal pocket will be made into the cornea with a femtosecond laser (Intralase). A small disc of preserved corneal tissue will then be placed into the pocket | Procedure or surgery | Corneal tissue inlay |
Primary outcome
Corneal tissue inlay for keratoconus
Time frame: 6 months
Change in maximum keratometry on corneal topography
Corneal tissue inlay for keratoconus
Time frame: 6 months
Uncorrected visual acuity
Corneal tissue inlay for keratoconus
Time frame: 6 months
Best spectacle corrected visual acuity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Derived from this study: PubMed 36943309Greenstein SA, Yu AS, Gelles JD, Eshraghi H, Hersh PS. Corneal tissue addition keratoplasty: new intrastromal inlay procedure for keratoconus using femtosecond laser-shaped preserved corneal tissue. J Cataract Refract Surg. 2023 Jul 1;49(7):740-746. doi: 10.1097/j.jcrs.0000000000001187.
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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 Hersh, 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 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 5 inclusion and 6 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 8 Feb 2023. 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?
Corneal tissue inlay for keratoconus (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02649738, which also lists 1 linked publication.
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 8 Feb 2023.