Bullous Keratopathy, Cornea, Corneal Dystrophy, Keratoconus
Conditions
Keywords
keratoconus, bullous keratopathy, corneal dystrophy
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: 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
Interventions
PROCEDURELumera Microscope with OCT RESCAN
corneal transplantation guided by Lumera Microscope with OCT RESCAN
PROCEDUREConventional Microscope
corneal transplantation guided by Conventional Microscope
Sponsors
Eye Clinic Day Hospital, São Paulo
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess optimal maneuvers in corneal transplantation (separation layers) | Day 0 | assessed by a questionnaire responded by surgeons (no difficulty, some difficulty, very difficulty) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare the time of surgery between groups | Day 0 | 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 | Day 0 | by a questionnaire responded by surgeons (no difficulty, some difficulty, very difficulty) |
| Change of Day 1 Ocular inflammation at 1 month (Day 30) | from Day1 to Day30 | ocular inflammation scored as mild, moderate or severe |
| Change from Baseline Intraocular Pressure at 6 months (Day180) | from Baseline to Day 180 | intraocular pressure assessed by goldmann tonometer |
| Change from Baseline Visual Acuity at 6 months (Day 180) | from Baseline to Day 180 | visual acuity tested by ETDRS chart |
Contacts
Primary ContactRicardo Nose, MD
Backup ContactLuci Silva, PhD
Outcome results
None listed