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| Name | Class |
|---|---|
| Eye Clinic Day Hospital, São Paulo | OTHER |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumera Microscope with OCT RESCAN | Procedure | corneal transplantation guided by Lumera Microscope with OCT RESCAN |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess optimal maneuvers in corneal transplantation (separation layers) | assessed by a questionnaire responded by surgeons (no difficulty, some difficulty, very difficulty) | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the time of surgery between groups | by a questionnaire responded by surgeons (until 30 minutes, between 30-60 minutes, more than 60 minutes) | Day 0 |
| To describe the surgical difficulty for corneal transplantation |
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Inclusion Criteria:
Visual acuity less than 20/60 in the affected eye
18 years at least
Diagnostic of the following diseases:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ricardo Nose, MD | Contact | 5511 984471694 | ricnose@gmail.com | |
| Luci Silva, PhD | Contact | +551155726443 | luci.silva@unifesp.br |
| Name | Affiliation | Role |
|---|---|---|
| Walton Nose, MD, PhD | Federal University of São Paulo | Principal Investigator |
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scientific publication
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| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D007640 | Keratoconus |
| D003317 | Corneal Dystrophies, Hereditary |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D015785 | Eye Diseases, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| Conventional Microscope | Procedure | corneal transplantation guided by Conventional Microscope |
|
by a questionnaire responded by surgeons (no difficulty, some difficulty, very difficulty)
| Day 0 |
| Change of Day 1 Ocular inflammation at 1 month (Day 30) | ocular inflammation scored as mild, moderate or severe | from Day1 to Day30 |
| Change from Baseline Intraocular Pressure at 6 months (Day180) | intraocular pressure assessed by goldmann tonometer | from Baseline to Day 180 |
| Change from Baseline Visual Acuity at 6 months (Day 180) | visual acuity tested by ETDRS chart | from Baseline to Day 180 |