CORNEAL OPACITY WITH POOR PROGNOSIS FOR CORNEAL TRANSPLANTNCT03812341
SINGLE PATIENT EXPANDED ACCESS OF 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
A study testing Experimental in people with CORNEAL OPACITY WITH POOR PROGNOSIS FOR CORNEAL TRANSPLANT, run by University of California, Irvine at 1 site in United States.
Trial summary
This is for a "Single Patient Expanded Access" of an on-going study (IRB#2017-3526). In the on-going study, the maximum number of subject will be 35 subjects (35 eyes) will be implanted with the KeraKlear device and will be followed for one year. Read more about this study
- Who is it for?
- Ages 88 to 88 years, women only
- Conditions the study is for
- CORNEAL OPACITY WITH POOR PROGNOSIS FOR CORNEAL TRANSPLANT
- What is being tested?
- Experimental
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2018to 9 Aug 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 88 to 88 years
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Corneal blindness where cornea transplantation is necessary but is expected to be unsuccessful due to severe limbal stem cell deficiency (LSCD) associated with aniridia or due to 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.
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 due to multiple (two or more) failed cornea transplantation surgeries.
- 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.
- 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.
- For this "Single Patient Expanded Access" the research procedures will be based on the Master Protocol Version #1.2 dated 18Dec2017, with one foreseen deviation. Section 7.1 Page 27 under Inclusion Criteria #1 Male or female from 22 years to 80 years of age at screening study visit. This patient is 88 years old.
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Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Irvine
Irvine, California, 92697
About this study
This is for a "Single Patient Expanded Access" of an on-going study (IRB#2017-3526). In the on-going study, the maximum number of subject will be 35 subjects (35 eyes) will be implanted with the KeraKlear device and will be followed for one year. However, this expanded access is for single patient use below is a description of patient condition and circumstances necessitating treatment:
88 year old female with 2 previous failed corneal transplants, had significant scarring and mild edema, surface well epithelialized, has potential for 10 letters of improvement in visual acuity. Patient is high risk for recurrent corneal rejection and failure and therefore would not be a candidate for standard corneal transplant. She would potentially do well with a partial thickness artificial cornea such as the KeraKlear.
Read the detailed description
For this "Single Patient Expanded Access" the research procedures will be based on the Master Protocol Version #1.2 dated 18Dec2017, with one foreseen deviation. Section 7.1 Page 27 under Inclusion Criteria #1 Male or female from 22 years to 80 years of age at screening study visit. This patient is 88 years old as of the submission of this Protocol Narrative to the IRB.
Postoperatively, subject will be examined at (with window size in parentheses):
- 1 Day (+2 days)
- 1 Week (7±2 days)
- 1 Month (30±5 days)
- 2 Months (60±7 days)
- 3 Months (90±7 days)
- 4 Months (120±10 days)
- 6 Months (180±10 days)
- 9 Months (270±20 days)
- 12 Months (360±20 days)
- Being tested
- Experimental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalOther
KeraKlear Non-Penetrating Keratoprosthesis The KeraKlear is a flexible non-penetrating artificial cornea designed to be implanted through small corneal incisions in subjects with corneal opacity
What is being measured
The primary outcome is the main question the study is designed to answer.
1.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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start10 Aug 2018
- Primary completion9 Aug 2019
- Study completion9 Aug 2019
Why it stopped: No enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CORNEAL OPACITY WITH POOR PROGNOSIS FOR CORNEAL TRANSPLANTStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03812341
- Sponsor's protocol ID
- 2018-4549
- Status last verified
- May 2020
- First submitted
- 18 Jan 2019
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SINGLE PATIENT EXPANDED ACCESS OF 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
- NCT03812341
- Acronym / sponsor ID
- 2018-4549
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 10 Aug 2018 (actual)
- Primary completion
- 9 Aug 2019 (actual)
- Study completion
- 9 Aug 2019 (actual)
- First posted
- 23 Jan 2019 (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.
This is for a "Single Patient Expanded Access" of an on-going study (IRB#2017-3526). In the on-going study, the maximum number of subject will be 35 subjects (35 eyes) will be implanted with the KeraKlear device and will be followed for one year. However, this expanded access is for single patient use below is a description of patient condition and circumstances necessitating treatment:
88 year old female with 2 previous failed corneal transplants, had significant scarring and mild edema, surface well epithelialized, has potential for 10 letters of improvement in visual acuity. Patient is high risk for recurrent corneal rejection and failure and therefore would not be a candidate for standard corneal transplant. She would potentially do well with a partial thickness artificial cornea such as the KeraKlear.
Detailed description
For this "Single Patient Expanded Access" the research procedures will be based on the Master Protocol Version #1.2 dated 18Dec2017, with one foreseen deviation. Section 7.1 Page 27 under Inclusion Criteria #1 Male or female from 22 years to 80 years of age at screening study visit. This patient is 88 years old as of the submission of this Protocol Narrative to the IRB.
Postoperatively, subject will be examined at (with window size in parentheses):
- 1 Day (+2 days)
- 1 Week (7±2 days)
- 1 Month (30±5 days)
- 2 Months (60±7 days)
- 3 Months (90±7 days)
- 4 Months (120±10 days)
- 6 Months (180±10 days)
- 9 Months (270±20 days)
- 12 Months (360±20 days)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 88 to 88 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Corneal blindness where cornea transplantation is necessary but is expected to be unsuccessful due to severe limbal stem cell deficiency (LSCD) associated with aniridia or due to 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.
Key exclusion criteria (26 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 due to multiple (two or more) failed cornea transplantation surgeries.
- 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 |
|---|---|---|
| ExperimentalKeraKlear Non-Penetrating Keratoprosthesis The KeraKlear is a flexible non-penetrating artificial cornea designed to be implanted through small corneal incisions in subjects with corneal opacity | Other | – |
Primary outcome
1.Improvement in BCDVA compared to baseline [ Time Frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 6, Month 9 and Month 12 ]
Time frame: 1 year
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 withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental in people with CORNEAL OPACITY WITH POOR PROGNOSIS FOR CORNEAL TRANSPLANT, run by University of California, Irvine 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 3 inclusion and 26 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: withdrawn, as of the sponsor's last update on 27 May 2020. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
1.Improvement in BCDVA compared to baseline [ Time Frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 6, Month 9 and Month 12 ] (time frame: 1 year). 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 27 May 2020.