Corneal Transplantation Guided by OCT RESCAN

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Corneal Transplantation Guided by OCT RESCAN: Pre-op, Intra-op and Post-op Evaluation

Conditions
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Cornea, Keratoconus, Bullous Keratopathy, Corneal Dystrophy

Intervention / Treatment
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* Procedure: Lumera Microscope with OCT RESCAN
* Procedure: Conventional Microscope


Participation Criteria
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Eligibility Criteria
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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: keratoconus Keratopathy Bullosa Corneal dystrophy Exclusion Criteria: Better visual acuity than or equal to 20/60

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lumera Microscope with OCT RESCAN<br>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 | Procedure: Lumera Microscope with OCT RESCAN<br>* corneal transplantation guided by Lumera Microscope with OCT RESCAN<br>|
| Active Comparator: Conventional Microscope<br>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 | Procedure: Conventional Microscope<br>* corneal transplantation guided by Conventional Microscope<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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keratoconus, bullous keratopathy, corneal dystrophy