CorneaNCT02736877
Corneal Transplantation Guided by OCT RESCAN
A study testing Lumera Microscope with OCT RESCAN and Conventional Microscope in people with Cornea and Keratoconus, run by Federal University of São Paulo.
Trial summary
The investigators will evaluate 30 patients with surgical indication for corneal transplantation. Participants will be divided according to the following diseases diseases: keratoconus, bullous keratopathy, corneal dystrophies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cornea, Keratoconus, Bullous Keratopathy
- What is being tested?
- Lumera Microscope with OCT RESCAN and Conventional Microscope
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Mar 2017
- 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
- Visual acuity less than 20/60 in the affected eye
- 18 years at least
- Diagnostic of the following diseases:
- keratoconus
- Keratopathy Bullosa
- Corneal dystrophy
Who cannot join
- Better visual acuity than or equal to 20/60
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Corneal Transplantation Guided by OCT RESCAN: Pre-op, Intra-op and Post-op Evaluation
The investigators will evaluate 30 patients with surgical indication for corneal transplantation. Participants will be divided according to the following diseases diseases: keratoconus, bullous keratopathy, corneal dystrophies. Participants will be informed about the risks and benefits of the study and sign an informed consent form. In the preoperative evaluation will be submitted to a complete ophthalmologic examination with complementary tests, such as optical coherence tomography.
One group of participants will undergo corneal surgery using the OCT Lumera microscope RESCAN - ZEISS and another group with a conventional microscope. Everyone will have their filmed and documented surgery. The team of surgeons will answer the questionnaire on the surgical difficulty about the ease of assessing corneal transplantation. After surgery, participants will be assessed on days 1, 7,15, 30, 60, 90 and 180 after surgery.
Surgeries and study procedures will be performed by the same team of surgeons and performed by IPEPO - Paulista Institute of Studies and Research in Ophthalmology / Vision Institute.
Read the detailed description
Participants will be allocated in one of the following groups:
- Control Group The control group will undergo corneal transplant with conventional microscope without coupled OCT. The team of surgeons will answer the questionnaire on the surgical difficulty regarding corneal transplantation (ANNEX 1).
- Group OCT RESCAN In the group microscope coupled to OCT, patients will undergo retinal surgery using the Lumera Microscope WITH RESCAN OCT - ZEISS. The team of surgeons will answer the questionnaire on the surgical difficulty regarding corneal transplantation (ANNEX 1).
The investigators will evaluate intraoperative conditions, complications, operative time and postoperative results in both groups.
All patients will be monitored and evaluated with full ophthalmological examination in all postoperative visits (day 1, 7,15,30, 60, 90, 180) and will be subjected to the following tests:
- Measurement of visual acuity with best correction
- Previous Biomicroscopy
- Corneal Topography
- tonometry
- Optical coherence tomography (OCT)
- Microscopy speculate
- Conditions
- Cornea, Keratoconus, Bullous Keratopathy, Corneal Dystrophy
- Being tested
- Lumera Microscope with OCT RESCAN, Conventional Microscope
- Keywords
- keratoconus, bullous keratopathy, corneal dystrophy
- Medical subject headings
- Corneal Diseases, Keratoconus, Corneal Dystrophies, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumera Microscope with OCT RESCANProcedure or surgery
corneal transplantation guided by Lumera Microscope with OCT RESCAN
Conventional MicroscopeProcedure or surgery
corneal transplantation guided by Conventional Microscope
| Study group | Role | What they receive |
|---|---|---|
| Lumera Microscope with OCT RESCAN | Experimental | In the group microscope coupled to OCT, patients will undergo corneal surgery using the Lumera Microscope WITH RESCAN OCT - ZEISS. The team of surgeons will answer the questionnaire on the surgical difficulty regarding corneal transplantation Receives: Procedure: Lumera Microscope with OCT RESCAN |
| Conventional Microscope | Active comparator | The control group will undergo corneal transplant with conventional microscope without coupled OCT. The team of surgeons will answer the questionnaire on the surgical difficulty regarding corneal transplantation Receives: Procedure: Conventional Microscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess optimal maneuvers in corneal transplantation (separation layers)
assessed by a questionnaire responded by surgeons (no difficulty, some difficulty, very difficulty)
Measured: Day 0
Secondary outcomes (5)
Compare the time of surgery between groups
by a questionnaire responded by surgeons (until 30 minutes, between 30-60 minutes, more than 60 minutes)
Measured: Day 0
To describe the surgical difficulty for corneal transplantation
by a questionnaire responded by surgeons (no difficulty, some difficulty, very difficulty)
Measured: Day 0
Change of Day 1 Ocular inflammation at 1 month (Day 30)
ocular inflammation scored as mild, moderate or severe
Measured: from Day1 to Day30
Change from Baseline Intraocular Pressure at 6 months (Day180)
intraocular pressure assessed by goldmann tonometer
Measured: from Baseline to Day 180
Change from Baseline Visual Acuity at 6 months (Day 180)
visual acuity tested by ETDRS chart
Measured: from Baseline to Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2016 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CorneaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Eye Clinic Day Hospital, São Paulo
- Responsible party
- Principal investigator, Walton Nose, Federal University of São Paulo
- Investigators
- Walton Nose, MD, PhD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02736877
- Sponsor's protocol ID
- RESCAN2016
- Status last verified
- Apr 2016
- First submitted
- 22 Mar 2016
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: scientific publication
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corneal Transplantation Guided by OCT RESCAN: Pre-op, Intra-op and Post-op Evaluation
- ClinicalTrials.gov ID
- NCT02736877
- Acronym / sponsor ID
- RESCAN2016
- Conditions
- Cornea, Keratoconus, Bullous Keratopathy, Corneal Dystrophy
- Keywords
- keratoconus, bullous keratopathy, corneal dystrophy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Eye Clinic Day Hospital, São Paulo
- Study start
- Apr 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 13 Apr 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.
The investigators will evaluate 30 patients with surgical indication for corneal transplantation. Participants will be divided according to the following diseases diseases: keratoconus, bullous keratopathy, corneal dystrophies. Participants will be informed about the risks and benefits of the study and sign an informed consent form. In the preoperative evaluation will be submitted to a complete ophthalmologic examination with complementary tests, such as optical coherence tomography.
One group of participants will undergo corneal surgery using the OCT Lumera microscope RESCAN - ZEISS and another group with a conventional microscope. Everyone will have their filmed and documented surgery. The team of surgeons will answer the questionnaire on the surgical difficulty about the ease of assessing corneal transplantation. After surgery, participants will be assessed on days 1, 7,15, 30, 60, 90 and 180 after surgery.
Surgeries and study procedures will be performed by the same team of surgeons and performed by IPEPO - Paulista Institute of Studies and Research in Ophthalmology / Vision Institute.
Detailed description
Participants will be allocated in one of the following groups:
- Control Group The control group will undergo corneal transplant with conventional microscope without coupled OCT. The team of surgeons will answer the questionnaire on the surgical difficulty regarding corneal transplantation (ANNEX 1).
- Group OCT RESCAN In the group microscope coupled to OCT, patients will undergo retinal surgery using the Lumera Microscope WITH RESCAN OCT - ZEISS. The team of surgeons will answer the questionnaire on the surgical difficulty regarding corneal transplantation (ANNEX 1).
The investigators will evaluate intraoperative conditions, complications, operative time and postoperative results in both groups.
All patients will be monitored and evaluated with full ophthalmological examination in all postoperative visits (day 1, 7,15,30, 60, 90, 180) and will be subjected to the following tests:
- Measurement of visual acuity with best correction
- Previous Biomicroscopy
- Corneal Topography
- tonometry
- Optical coherence tomography (OCT)
- Microscopy speculate
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumera Microscope with OCT RESCAN | Experimental | Procedure: Lumera Microscope with OCT RESCANIn the group microscope coupled to OCT, patients will undergo corneal surgery using the Lumera Microscope WITH RESCAN OCT - ZEISS. The team of surgeons will answer the questionnaire on the surgical difficulty regarding corneal transplantation |
| Conventional Microscope | Active comparator | Procedure: Conventional MicroscopeThe control group will undergo corneal transplant with conventional microscope without coupled OCT. The team of surgeons will answer the questionnaire on the surgical difficulty regarding corneal transplantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Visual acuity less than 20/60 in the affected eye
- 18 years at least
- Diagnostic of the following diseases:
Key exclusion criteria (1 listed)
- Better visual acuity than or equal to 20/60
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 |
|---|---|---|
| Lumera Microscope with OCT RESCANcorneal transplantation guided by Lumera Microscope with OCT RESCAN | Procedure or surgery | Lumera Microscope with OCT RESCAN |
| Conventional Microscopecorneal transplantation guided by Conventional Microscope | Procedure or surgery | Conventional Microscope |
Primary outcome
Assess optimal maneuvers in corneal transplantation (separation layers)
Time frame: Day 0
assessed by a questionnaire responded by surgeons (no difficulty, some difficulty, very difficulty)
5 secondary outcomes
Compare the time of surgery between groups
Time frame: Day 0
To describe the surgical difficulty for corneal transplantation
Time frame: Day 0
Change of Day 1 Ocular inflammation at 1 month (Day 30)
Time frame: from Day1 to Day30
Change from Baseline Intraocular Pressure at 6 months (Day180)
Time frame: from Baseline to Day 180
Change from Baseline Visual Acuity at 6 months (Day 180)
Time frame: from Baseline to Day 180
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2016.
- Individual participant dataSharing planned: Yes. scientific publication
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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.
Walton Nose, MD, PhD principal investigator
Federal University of São Paulo
Questions about this trial
What is this clinical trial studying?
A study testing Lumera Microscope with OCT RESCAN and Conventional Microscope in people with Cornea and Keratoconus, run by Federal University of São Paulo.
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 1 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 13 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Ricardo Nose, MD (5511 984471694, ricnose@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess optimal maneuvers in corneal transplantation (separation layers) (time frame: Day 0). 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 13 Apr 2016.