Corneal Dystrophy, Epithelial Basement MembraneNCT02766907
Optimizing the Ocular Surface Prior to Cataract Surgery
A study testing cryopreserved amniotic membrane in people with Corneal Dystrophy, Epithelial Basement Membrane, run by BioTissue Holdings, Inc at 1 site in United States.
Trial summary
Prospective study to evaluate the efficacy of using self-retained cryopreserved amniotic membrane after debridement in treating Epithelial Base Membrane Dystrophy (EBMD) to optimize the ocular surface integrity and intraocular lens calculation before cataract surgery. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Corneal Dystrophy, Epithelial Basement Membrane
- What is being tested?
- cryopreserved amniotic membrane
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Apr 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with significant EBMD that are contemplating cataract surgery.
- Age range: 50 years and older.
- Both Genders and all ethnic groups comparable with the local community.
- Subjects able to understand and willing to sign a written informed consent.
- Subjects able and willing to cooperate with the investigational plan.
- Subjects able and willing to complete postoperative follow-up.
Who cannot join
- Subjects with known intolerance to PKS or known allergy to its preservative media.
- Subjects with symblepharon or lid abnormality preventing PKS placement.
- Ocular infection within 14 days prior to study entry.
- Previous ocular surgery or injury within 3 months before enrollment.
- Subjects with a history of non-healing epithelial defect or neurotrophic keratitis.
- Inability or unwillingness of subject to give written informed consent, follow investigational plan or complete postoperative follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Prospective study to evaluate the efficacy of using self-retained cryopreserved amniotic membrane after debridement in treating Epithelial Base Membrane Dystrophy (EBMD) to optimize the ocular surface integrity and intraocular lens calculation before cataract surgery.
- Being tested
- cryopreserved amniotic membrane
- Medical subject headings
- Corneal dystrophy, epithelial basement membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryopreserved amniotic membraneDevice
Also called Prokera Slim (PKS)
placement of cryopreserved amniotic membrane after routine debridement procedure for EBMD
| Study group | Role | What they receive |
|---|---|---|
| Study | Active comparator | prospective arm receiving cryopreserved amniotic membrane Receives: Device: cryopreserved amniotic membrane |
| Control | No intervention | Retrospective review of debridement without cryopreserved amniotic membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Intraocular Lens Calculation
Assessed by corneal topography
Measured: Change from Baseline to 1 month
Change in Intraocular Lens Power Calculation
Assessed using biometry and calculated using Holladay I formula
Measured: Change from Baseline to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2016 (estimated)
- Study startMar 2016
- Primary completionJan 2017
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Corneal Dystrophy, Epithelial Basement MembraneStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioTissue Holdings, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elizabeth Yeu, MD, Principal investigator, Virginia Eye Consultants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02766907
- Sponsor's protocol ID
- P015-2
- Status last verified
- Mar 2019
- First submitted
- 25 Apr 2016
- Last updated
- 19 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing the Ocular Surface Prior to Cataract Surgery
- ClinicalTrials.gov ID
- NCT02766907
- Acronym / sponsor ID
- P015-2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- BioTissue Holdings, IncIndustry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 10 May 2016 (estimated)
- Results
- Posted 5 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective study to evaluate the efficacy of using self-retained cryopreserved amniotic membrane after debridement in treating Epithelial Base Membrane Dystrophy (EBMD) to optimize the ocular surface integrity and intraocular lens calculation before cataract surgery.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study | Active comparator | Device: cryopreserved amniotic membraneprospective arm receiving cryopreserved amniotic membrane |
| Control | No intervention | –Retrospective review of debridement without cryopreserved amniotic membrane |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects with significant EBMD that are contemplating cataract surgery.
- Age range: 50 years and older.
- Both Genders and all ethnic groups comparable with the local community.
- Subjects able to understand and willing to sign a written informed consent.
- Subjects able and willing to cooperate with the investigational plan.
Key exclusion criteria (6 listed)
- Subjects with known intolerance to PKS or known allergy to its preservative media.
- Subjects with symblepharon or lid abnormality preventing PKS placement.
- Ocular infection within 14 days prior to study entry.
- Previous ocular surgery or injury within 3 months before enrollment.
- Subjects with a history of non-healing epithelial defect or neurotrophic keratitis.
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 |
|---|---|---|
| cryopreserved amniotic membraneAlso: Prokera Slim (PKS)placement of cryopreserved amniotic membrane after routine debridement procedure for EBMD | Device | Study |
Primary outcome
Change in Intraocular Lens Calculation
Time frame: Change from Baseline to 1 month
Assessed by corneal topography
Change in Intraocular Lens Power Calculation
Time frame: Change from Baseline to 1 month
Assessed using biometry and calculated using Holladay I formula
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Brillouin Microscopy Used to Evaluate Corneal Mechanical Properties
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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.
Elizabeth Yeu, MD principal investigator
Virginia Eye Consultants
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cryopreserved amniotic membrane in people with Corneal Dystrophy, Epithelial Basement Membrane, run by BioTissue Holdings, Inc 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 6 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: finished, as of the sponsor's last update on 19 Mar 2019. 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?
Yes. Results are posted in the registry (first posted 5 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Intraocular Lens Calculation (time frame: Change from Baseline to 1 month). The study lists 2 primary outcomes in all. 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 19 Mar 2019.