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| Name | Class |
|---|---|
| Instituto Paulista de Estudos e Pesquisa em Oftalmologia | OTHER |
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In our study , the investigators will use the microscope with OCT ( Lumera with RESCAN OCT ) coupled to assess the extent , depth and change of retinal architecture in the perioperative period . Thus , they will evaluate what the optimal maneuvers of dissection of macular membranes to obtain a more satisfactory result of the rearrangement in the retinal layers . Furthermore , the use of OCT perioperative may dispense with the use of dyes , decreasing the concentration used or reduce the exposure time. Thus, they can get the potential decrease in retinal toxicity may be generated by them.
The investigators will use the microscope with OCT (Lumera with RESCAN OCT) coupled to assess the extent, depth and change of retinal architecture in the perioperative period. Thus, they will evaluate what the optimal maneuvers of dissection of macular membranes to obtain a more satisfactory result of the rearrangement in the retinal layers. Furthermore, the use of OCT perioperative may dispense with the use of dyes, decreasing the concentration used or reduce the exposure time.
Materials and methods The investigators will evaluate 30 patients with changes in macular membranes with surgical removal of indication from the Retina and Vitreous outpatient sector of Unifesp - Paulista School of Medicine. The patients will be classified according to the diseases in the following groups: Macular Hole, Epiretinal Membrane, Traction Syndrome vitreomacular, and proliferative vitreoretinopathy of Retinal Detachment. Everyone will be informed about the risks and benefits of the study and sign an informed consent form. In the preoperative evaluation a complete ophthalmologic examination with complementary tests such as angiography and optical coherence tomography will be done.
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 the identification and removal of macular membranes.
All patients will be assessed at 1, 7, 15, 30, 60 and 90 and 180 days after surgery, including the following tests:
For each type of retinal disease, there will be a control group and a group OCT as detailed below: 1 - GROUP CONTROL The control group will undergo retinal surgery with conventional microscope without coupled OCT. This group will have its filmed and documented surgery. The team of surgeons will answer the questionnaire on the surgical difficulty regarding the identification and removal of macular membranes.
2 -GROUP OCT / RESCAN In the group microscope coupled to OCT, patients will undergo retinal surgery using the Lumera Microscope WITH RESCAN OCT - ZEISS and have their filmed and documented surgery. The team of surgeons will answer the questionnaire on the surgical difficulty regarding the identification and removal of macular membranes.
Statistical methodology All information will be presented by mean and standard deviation for the quantitative variables and absolute frequency (n) and relative (%) for qualitative variables.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lumera Microscope with OCT RESCAN | Other | in the group microscope coupled to OCT, patients will undergo retinal surgery using the Lumera microscope with Rescan OCT Zeiss |
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| Conventional Microscope | Other | control group without OCT RESCAN |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumera Microscope with OCT RESCAN | Procedure | macular membrane dissection with OCT RESCAN |
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| Measure | Description | Time Frame |
|---|---|---|
| Assess optimal maneuvers in macular membrane dissection | by a questionnaire responded by surgeons (no difficulty, some difficulty, very difficulty) | Day 0 (surgical day) |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the time of surgery between groups | by a questionnaire responded by surgeons (until 1 hour, between 1-2 hours, more than 2 hours | Day 0 (surgical day) |
| describe the surgical difficulty for macular membrane dissection |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diego Verginassi, MD | Contact | 5511-985564262 | diegoverginassi@gmail.com | |
| Luci Silva | Contact | +551155726443 | luci.pesquisa@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Michel Farah, MD, PhD | Federal University of São Paulo | Principal Investigator |
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scientific publication
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| ID | Term |
|---|---|
| D012167 | Retinal Perforations |
| D019773 | Epiretinal Membrane |
| D018630 | Vitreoretinopathy, Proliferative |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| Conventional Microscope | Procedure | macular membrane dissection without OCT RESCAN |
|
by a questionnaire responded by surgeons (no difficulty, some difficulty, very difficulty)
| Day 0 |