Corneal Transplantation Guided by OCT RESCAN
NCT02736877 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2016-04-13
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.
Conditions
- Cornea
- Keratoconus
- Bullous Keratopathy
- Corneal Dystrophy
Interventions
- PROCEDURE
-
Lumera Microscope with OCT RESCAN
corneal transplantation guided by Lumera Microscope with OCT RESCAN
- PROCEDURE
-
Conventional Microscope
corneal transplantation guided by Conventional Microscope
Sponsors & Collaborators
-
Eye Clinic Day Hospital, São Paulo
collaborator OTHER -
Federal University of São Paulo
lead OTHER
Principal Investigators
-
Walton Nose, MD, PhD · Federal University of São Paulo UNIFESP
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-04-30
- Primary Completion
- 2016-12-31
- Completion
- 2017-03-31
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