Corneal Transplantation Guided by OCT RESCAN
Primary Purpose
Cornea, Keratoconus, Bullous Keratopathy
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lumera Microscope with OCT RESCAN
Conventional Microscope
Sponsored by
About this trial
This is an interventional treatment trial for Cornea focused on measuring keratoconus, bullous keratopathy, corneal dystrophy
Eligibility Criteria
Inclusion Criteria:
- Visual acuity less than 20/60 in the affected eye
- 18 years at least
Diagnostic of the following diseases:
- keratoconus
- Keratopathy Bullosa
- Corneal dystrophy
Exclusion Criteria:
- Better visual acuity than or equal to 20/60
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lumera Microscope with OCT RESCAN
Conventional Microscope
Arm Description
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
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
Outcomes
Primary Outcome Measures
Assess optimal maneuvers in corneal transplantation (separation layers)
assessed by a questionnaire responded by surgeons (no difficulty, some difficulty, very difficulty)
Secondary Outcome Measures
Compare the time of surgery between groups
by a questionnaire responded by surgeons (until 30 minutes, between 30-60 minutes, more than 60 minutes)
To describe the surgical difficulty for corneal transplantation
by a questionnaire responded by surgeons (no difficulty, some difficulty, very difficulty)
Change of Day 1 Ocular inflammation at 1 month (Day 30)
ocular inflammation scored as mild, moderate or severe
Change from Baseline Intraocular Pressure at 6 months (Day180)
intraocular pressure assessed by goldmann tonometer
Change from Baseline Visual Acuity at 6 months (Day 180)
visual acuity tested by ETDRS chart
Full Information
NCT ID
NCT02736877
First Posted
March 22, 2016
Last Updated
April 8, 2016
Sponsor
Federal University of São Paulo
Collaborators
Eye Clinic Day Hospital, São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT02736877
Brief Title
Corneal Transplantation Guided by OCT RESCAN
Official Title
Corneal Transplantation Guided by OCT RESCAN: Pre-op, Intra-op and Post-op Evaluation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
March 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
Collaborators
Eye Clinic Day Hospital, São Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cornea, Keratoconus, Bullous Keratopathy, Corneal Dystrophy
Keywords
keratoconus, bullous keratopathy, corneal dystrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lumera Microscope with OCT RESCAN
Arm Type
Experimental
Arm Description
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
Arm Title
Conventional Microscope
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Lumera Microscope with OCT RESCAN
Intervention Description
corneal transplantation guided by Lumera Microscope with OCT RESCAN
Intervention Type
Procedure
Intervention Name(s)
Conventional Microscope
Intervention Description
corneal transplantation guided by Conventional Microscope
Primary Outcome Measure Information:
Title
Assess optimal maneuvers in corneal transplantation (separation layers)
Description
assessed by a questionnaire responded by surgeons (no difficulty, some difficulty, very difficulty)
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Compare the time of surgery between groups
Description
by a questionnaire responded by surgeons (until 30 minutes, between 30-60 minutes, more than 60 minutes)
Time Frame
Day 0
Title
To describe the surgical difficulty for corneal transplantation
Description
by a questionnaire responded by surgeons (no difficulty, some difficulty, very difficulty)
Time Frame
Day 0
Title
Change of Day 1 Ocular inflammation at 1 month (Day 30)
Description
ocular inflammation scored as mild, moderate or severe
Time Frame
from Day1 to Day30
Title
Change from Baseline Intraocular Pressure at 6 months (Day180)
Description
intraocular pressure assessed by goldmann tonometer
Time Frame
from Baseline to Day 180
Title
Change from Baseline Visual Acuity at 6 months (Day 180)
Description
visual acuity tested by ETDRS chart
Time Frame
from Baseline to Day 180
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Visual acuity less than 20/60 in the affected eye
18 years at least
Diagnostic of the following diseases:
keratoconus
Keratopathy Bullosa
Corneal dystrophy
Exclusion Criteria:
Better visual acuity than or equal to 20/60
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ricardo Nose, MD
Phone
5511 984471694
Email
ricnose@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Luci Silva, PhD
Phone
+551155726443
Email
luci.silva@unifesp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walton Nose, MD, PhD
Organizational Affiliation
Federal University of São Paulo UNIFESP
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
scientific publication
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Corneal Transplantation Guided by OCT RESCAN
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