Corneal BlindnessNCT03126903
A Clinical Study to Evaluate the KeraKlear Keratoprosthesis in Patients With Corneal Opacity
A study testing KeraKlear Non-Penetrating Keratoprosthesis in people with Corneal Blindness, run by KeraMed, Inc. at 4 sites in United States.
Trial summary
To evaluate the safety and probable benefit of the KeraKlear Non-Penetrating Keratoprosthesis when implanted in an eye with corneal opacity that is at high risk of complications with PK. Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Corneal Blindness
- What is being tested?
- KeraKlear Non-Penetrating Keratoprosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 4 sitesUnited States
- Study dates
- 22 Mar 2018to 30 Nov 2019
- 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 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Corneal blindness where cornea transplantation is necessary but with a high risk of graft failure due to
- severe limbal stem cell deficiency (LSCD) associated with aniridia or
- one full-thickness graft failure and at high risk of a failed second graft; specifically, those who have either young recipient age (age less than 40 years), a history of anterior segment surgery (in addition to prior PKP), and/or pre-operative glaucoma or
- multiple (two or more) failed cornea transplantation surgeries and spontaneous visual improvement without surgical intervention is not expected or probable.
- Best Corrected Distance Visual Acuity (Snellen) which is equal or worse than 20/200 in the study eye (but at least light perception with projection)
- Estimated visual potential of the study eye is greater than or equal to at least two lines visual improvement of BCDVA of current vision in the study eye.
- Patient and/or caregiver willing and able to insert and remove bandage contact lens.
Who cannot join
- Visual Acuity of No Light Perception (NLP) in the study eye
- The patient is monocular or the non-study eye has Best Corrected Distance Visual Acuity (Snellen) of worse than 20/160 due to an ocular condition other than severe aniridic limbal stem cell deficiency or failed cornea transplantation surgery(ies).
- Suitable for standard PK with donor tissue in the study eye.
- History of severe dry eye syndrome or a Schirmer test with results of less than 3mm after 5 minutes of testing with the use of topical anesthetic in either eye.
- Active or history of an auto-immune disease (e.g. Rheumatoid Arthritis, Ocular Cicatricial Pemphigoid, Lupus, Steven's Johnson Syndrome, atopic keratoconjunctivitis, etc.).
- On medications that may affect wound healing, such as antimetabolites or other chemotherapeutic agents.
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- History of posterior segment eye disease in either eye (including macular degeneration, optic neuropathy, posterior uveitis) which is expected to limit the visual improvement to less than two lines of vision.
- History of retinal surgery in the fellow eye (including retinal detachment repair, intravitreal injection etc.).
- History of retinal surgery in the study eye (including retinal detachment repair, intravitreal injection, etc.) unless the vision is at least light perception with projection in four field quadrants and the macula is attached (if there is no view of the retina, an ultrasound must show the macula is attached).
- History of uncontrolled glaucoma in either eye (IOP has been measured above 25 mmHg at any time in the last 6 months).
- Current use of beta blocker eye drops (e.g. timolol, levobunolol, etc.).
- Vertical cup-to-disc (C:D) ratio greater than or equal to 0.8 in either eye (if able to visible through corneal opacity). If not visible, patient is not to be excluded.
- Limited visual potential (patient does not have the ability to improve a minimum of two lines of vision of BCDVA by history).
- History of amblyopia in the study eye limiting visual potential.
- If the patient has had a corneal transplant, corneal transplantation surgery was performed less than 2 years ago.
- Anticipated need for surgery on the study eye during the course of the study (including cataract surgery).
- Aphakia in the study eye.
- Active ocular infection in either eye.
- Hypotony in the study eye (IOP < 6mmHg).
- History of herpetic ocular infection in the study eye.
- Corneal thickness less than 400 microns in any region of the pachymetry map, i.e.
- lamellar resection depth would be <100 microns from corneal endothelium accounting for the optic height of the selected implant design (i.e. 300 microns for KeraKlear or 500 microns for KeraKlear XT model)..
- Inability to protect the operated eye from trauma.
- Females who are pregnant, lactating, or unwilling to use adequate birth control for t the duration of the study.
- Patient is currently taking Sumatriptan (Imitrex) and unable to discontinue during the study.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Massachussetts Eye and Ear Infirmary
Boston, Massachusetts, 02114
Duke University School of Medicine - Dept. of Ophthalmology
Durham, North Carolina, 27710
Cincinnati Eye Institute
Edgewood, Kentucky, 41017
University of California Irvine
Irvine, California, 92697
About this study
Official title: A Prospective, Multicenter Clinical Trial Designed to Evaluate the Safety and Probable Benefit of the KeraKlear Non-Penetrating Keratoprosthesis in Subjects With Corneal Opacity With Poor Prognosis for Corneal Transplant
To evaluate the safety and probable benefit of the KeraKlear Non-Penetrating Keratoprosthesis when implanted in an eye with corneal opacity that is at high risk of complications with PK.
Read the detailed description
To evaluate the safety and probable benefit of the KeraKlear Non-Penetrating Keratoprosthesis when implanted in an eye with corneal opacity that is at high risk of complications with PK. A prospective, multicenter, clinical trial, designed to demonstrate the safety and performance of the KeraKlear Non-Penetrating Keratoprosthesis.
- Conditions
- Corneal Blindness
- Being tested
- KeraKlear Non-Penetrating Keratoprosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KeraKlear Non-Penetrating KeratoprosthesisDevice
The KeraKlear is a flexible non-penetrating artificial cornea designed to be implanted through small corneal incisions in subjects with corneal opacity.
| Study group | Role | What they receive |
|---|---|---|
| Single-Arm | Experimental | KeraKlear Non-Penetrating Keratoprosthesis Receives: Device: KeraKlear Non-Penetrating Keratoprosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in BCDVA compared to baseline
Best Corrected Distance Visual Acuity (BCDVA) will be measured in the study eye. An ETDRS visual acuity chart will be used to measure BCDVA at baseline, Month 1, Month 2, Month 3, Month 4, Month 6, Month 9, and Month 12.
Measured: Baseline, Month 1, Month 2, Month 3, Month 4, Month 6, Month 9 and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start22 Mar 2018
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Why it stopped: KeraMed is being discontinued because it is no longer feasible due to the slow pace of recruitment and insufficient financial resources.
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 Corneal BlindnessStudies 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
- Model description
- Single arm, open-label clinical trial
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- KeraMed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Eye Institute (NEI), ClinReg Consulting Services, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03126903
- Sponsor's protocol ID
- KERA002
- Other IDs
- 1R44EY021664-01
- Status last verified
- Dec 2019
- First submitted
- 20 Apr 2017
- Last updated
- 10 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kilian R, Lammer J, Roberts P, Rizzo C, Pedrotti E, Marchini G, Schmidinger G. Nonpenetrating Foldable Intrastromal Keratoprosthesis: A Review of the Literature. Cornea. 2024 Jul 1;43(7):909-915. doi: 10.1097/ICO.0000000000003500. Epub 2024 Feb 21.
PubMed 38381061
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Clinical Trial Designed to Evaluate the Safety and Probable Benefit of the KeraKlear Non-Penetrating Keratoprosthesis in Subjects With Corneal Opacity With Poor Prognosis for Corneal Transplant
- ClinicalTrials.gov ID
- NCT03126903
- Acronym / sponsor ID
- KERA002
- Conditions
- Corneal Blindness
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: KeraMed is being discontinued because it is no longer feasible due to the slow pace of recruitment and insufficient financial resources.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- KeraMed, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Eye Institute (NEI), ClinReg Consulting Services, Inc.
- Study start
- 22 Mar 2018 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 25 Apr 2017 (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.
To evaluate the safety and probable benefit of the KeraKlear Non-Penetrating Keratoprosthesis when implanted in an eye with corneal opacity that is at high risk of complications with PK.
Detailed description
To evaluate the safety and probable benefit of the KeraKlear Non-Penetrating Keratoprosthesis when implanted in an eye with corneal opacity that is at high risk of complications with PK. A prospective, multicenter, clinical trial, designed to demonstrate the safety and performance of the KeraKlear Non-Penetrating Keratoprosthesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm, open-label clinical trial
| Arm | Type | Receives |
|---|---|---|
| Single-Arm | Experimental | Device: KeraKlear Non-Penetrating KeratoprosthesisKeraKlear Non-Penetrating Keratoprosthesis |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Corneal blindness where cornea transplantation is necessary but with a high risk of graft failure due to
- Best Corrected Distance Visual Acuity (Snellen) which is equal or worse than 20/200 in the study eye (but at least light perception with projection)
- Estimated visual potential of the study eye is greater than or equal to at least two lines visual improvement of BCDVA of current vision in the study eye.
- Patient and/or caregiver willing and able to insert and remove bandage contact lens.
Key exclusion criteria (25 listed)
- Visual Acuity of No Light Perception (NLP) in the study eye
- The patient is monocular or the non-study eye has Best Corrected Distance Visual Acuity (Snellen) of worse than 20/160 due to an ocular condition other than severe aniridic limbal stem cell deficiency or failed cornea transplantation surgery(ies).
- Suitable for standard PK with donor tissue in the study eye.
- History of severe dry eye syndrome or a Schirmer test with results of less than 3mm after 5 minutes of testing with the use of topical anesthetic in either eye.
- Active or history of an auto-immune disease (e.g. Rheumatoid Arthritis, Ocular Cicatricial Pemphigoid, Lupus, Steven's Johnson Syndrome, atopic keratoconjunctivitis, etc.).
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 |
|---|---|---|
| KeraKlear Non-Penetrating KeratoprosthesisThe KeraKlear is a flexible non-penetrating artificial cornea designed to be implanted through small corneal incisions in subjects with corneal opacity. | Device | Single-Arm |
Primary outcome
Improvement in BCDVA compared to baseline
Time frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 6, Month 9 and Month 12
Best Corrected Distance Visual Acuity (BCDVA) will be measured in the study eye. An ETDRS visual acuity chart will be used to measure BCDVA at baseline, Month 1, Month 2, Month 3, Month 4, Month 6, Month 9, and Month 12.
Results and safety
The study was stopped early (reason given: KeraMed is being discontinued because it is no longer feasible due to the slow pace of recruitment and insufficient financial resources.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2019.
- Derived from this study: PubMed 38381061Kilian R, Lammer J, Roberts P, Rizzo C, Pedrotti E, Marchini G, Schmidinger G. Nonpenetrating Foldable Intrastromal Keratoprosthesis: A Review of the Literature. Cornea. 2024 Jul 1;43(7):909-915. doi: 10.1097/ICO.0000000000003500. Epub 2024 Feb 21.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KeraKlear Non-Penetrating Keratoprosthesis in people with Corneal Blindness, run by KeraMed, Inc. at 4 sites 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 7 inclusion and 25 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: stopped early, as of the sponsor's last update on 10 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study was stopped early (reason given: KeraMed is being discontinued because it is no longer feasible due to the slow pace of recruitment and insufficient financial resources.). 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?
Improvement in BCDVA compared to baseline (time frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 6, Month 9 and Month 12). 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 NCT03126903, 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 10 Dec 2019.