KeratoconusPhase 2NCT00409955
Lamellar Transplant With Lyophilized Corneas
A Phase 2 study testing Lamellar transplant with lyophilized corneas in people with Keratoconus, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The goals of this study are to develop a lyophilization method for anterior lamellar transplants in Brasil and to make a comparative analysis among patients transplanted with lyophilized and optisol corneas Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratoconus
- What is being tested?
- Lamellar transplant with lyophilized corneas
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2005to Dec 2006
- Phase
- Phase 2
- 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
- Keratoconus patient
- BCVA < 20/60
- No systemic diseases
- Who signed the inform consent
Who cannot join
- BCVA > 20/60
- Presence of deep opacities
- Systemic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial for Lamellar Transplants Using Lyophilized and Optisol Corneas
- The goals of this study are to develop a lyophilization method for anterior lamellar transplants in Brasil and to make a comparative analysis among patients transplanted with lyophilized and optisol corneas
Read the detailed description
- After the development of a techinique to lyophilize corneas, we randomly assingned 20 patients with keratoconus and visual acuity of < 20/60, who signed the consent term and divided them into 2 groups. One group was transplanted with lyophilized corneas and the other group with optisol corneas.
- Patients are being followed for 6 months with visual acuity, refraction, topography, orbscan, pachmetry, ultrasound biomicroscopy and confocal microscopy.
- Results are going to be statistically analysed by SPSS program.
- Conditions
- Keratoconus
- Being tested
- Lamellar transplant with lyophilized corneas
- Keywords
- Lamellar transplant, Lyophilization, Corneas storage, Keratoconus patients, Best corrected visual acuity < 20/60, Signed the consent inform
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lamellar transplant with lyophilized corneasProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Topography
Orbscan
Pachmetry
Ultrasound Biomicroscopy
Confocal Microscopy
Masked Examiner to evaluate transparency and quality of the transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2006 (estimated)
- Study startDec 2005
- Study completionDec 2006
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo, Sorocaba Eye Bank
- Investigators
- Roberta JM Farias, MD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00409955
- Sponsor's protocol ID
- CEP 1536/05
- Status last verified
- Dec 2006
- First submitted
- 11 Dec 2006
- Last updated
- 12 Dec 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial for Lamellar Transplants Using Lyophilized and Optisol Corneas
- ClinicalTrials.gov ID
- NCT00409955
- Acronym / sponsor ID
- CEP 1536/05
- Conditions
- Keratoconus
- Keywords
- Lamellar transplant, Lyophilization, Corneas storage, Keratoconus patients, Best corrected visual acuity < 20/60, Signed the consent inform
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- University of Sao Paulo, Sorocaba Eye Bank
- Study start
- Dec 2005
- Study completion
- Dec 2006
- First posted
- 12 Dec 2006 (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.
- The goals of this study are to develop a lyophilization method for anterior lamellar transplants in Brasil and to make a comparative analysis among patients transplanted with lyophilized and optisol corneas
Detailed description
- After the development of a techinique to lyophilize corneas, we randomly assingned 20 patients with keratoconus and visual acuity of < 20/60, who signed the consent term and divided them into 2 groups. One group was transplanted with lyophilized corneas and the other group with optisol corneas.
- Patients are being followed for 6 months with visual acuity, refraction, topography, orbscan, pachmetry, ultrasound biomicroscopy and confocal microscopy.
- Results are going to be statistically analysed by SPSS program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Keratoconus patient
- BCVA < 20/60
- No systemic diseases
- Who signed the inform consent
Key exclusion criteria (3 listed)
- BCVA > 20/60
- Presence of deep opacities
- Systemic diseases
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 |
|---|---|---|
| Lamellar transplant with lyophilized corneas | Procedure or surgery | – |
Primary outcome
Topography
Orbscan
Pachmetry
Ultrasound Biomicroscopy
Confocal Microscopy
Masked Examiner to evaluate transparency and quality of the transplant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2006.
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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.
Roberta JM Farias, MD principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lamellar transplant with lyophilized corneas in people with Keratoconus, run by Federal University of São Paulo at 1 site in Brazil.
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 4 inclusion and 3 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 12 Dec 2006. 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 Brazil. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Topography. The study lists 6 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 12 Dec 2006.