Keratoconus Clinical Trial
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.
Participants will be allocated in one of the following groups:
1. 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).
2. 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
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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