Efficiency of Intraoperative Optical Coherence Tomography (iOCT)
NCT ID: NCT05232539
Last Updated: 2022-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
2 participants
INTERVENTIONAL
2022-05-31
2023-12-31
Brief Summary
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Hypothesis:
The use of iOCT during surgery offers the advantage of a new view of the operating field, theoretically allows more precise performance and can also change decision-making mechanisms during surgery with more precise visual control of some surgical steps (incision adaptation, differentiation of healthy and pathological tissue, placement of the implant, graft, etc.) The disadvantage is the prolongation of the operation and thus the theoretical increase in possible complications related to the operation (bleeding, infection, patient subjective problems - pain, restlessness, poorer cooperation and the resulting other possible risks, such as unexpected patient movement).
Aim:
Determining the effectiveness of iOCT use in different types of eye surgery. Evaluation of advantages and disadvantages of using iOCT.
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Detailed Description
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The effectiveness of iOCT use will be monitored in three types of microsurgical eye surgery:
1. Lamellar corneal transplantation type DMEK
2. Antiglaucoma surgery - Deep sclerectomy with implantation of subchoroidal implant Esnoper Clip
3. Pars plana vitrectomy with epiretinal membrane peeling
For each type of the surgery, the investigators expect to perform about 50 surgeries, individual procedures will be randomly divided into 2 subgroups of 25 patients with and without the use of iOCT during the operation.
Perioperatively, the surgeon will record the number of complications, the net time of the operation and impressions using a questionnaire. The patient will evaluate the subjective perception of the operation using a questionnaire (pain, pressure, subjectively perceived duration of the operation).
The investigators will evaluate the clinical outcome of the operation postoperatively at intervals of 1 week, 1, 3 and 6 months - corrected and uncorrected visual acuity, intraocular pressure, inflammation reaction (SUN - standardization of uveitis nomenclature) and possible postoperative complications in all groups.
In each group the investigators will also specifically evaluate the achievement of the planned surgical goal in the group:
1. attachment of the lamella (respectively% area of lamella ablation) on the slit lamp, number of necessary reoperations - rebubbling, and density of the transplanted endothelium using the endothelial microscope
2. correct localization of the Esnoper Clip implant and confirmation of its functionality (decentration of the implant in millimeters, functionality expressed by the size of filtration into the subcleral and suprachoroidal space (using stationary OCT), the amount of postoperative antiglaucoma therapy required).
3. Frequency of epiretinal membrane residues (using stationary OCT)
4. Histological verification of tissues identified on the basis of iOCT during surgery (in Deep sclerectomy and Pars plana vitrectomy patients)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DEVICE_FEASIBILITY
NONE
Study Groups
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Lamellar corneal transplantation type DMEK
50 operations, procedure will be randomly divided into 2 subgroups of 25 patients with and without the use of iOCT during the operation.
Intraoperative Optical Coherence Tomography (iOCT)
The use of iOCT during surgery offers the advantage of a new view of the operating field, theoretically allows more precise performance and can also change decision-making mechanisms during surgery with more precise visual control of some surgical steps.
Deep sclerectomy with implantation of subchoroidal implant Esnoper Clip
50 operations, procedure will be randomly divided into 2 subgroups of 25 patients with and without the use of iOCT during the operation.
Intraoperative Optical Coherence Tomography (iOCT)
The use of iOCT during surgery offers the advantage of a new view of the operating field, theoretically allows more precise performance and can also change decision-making mechanisms during surgery with more precise visual control of some surgical steps.
Pars plana vitrectomy with epiretinal membrane peeling
50 operations, procedure will be randomly divided into 2 subgroups of 25 patients with and without the use of iOCT during the operation.
Intraoperative Optical Coherence Tomography (iOCT)
The use of iOCT during surgery offers the advantage of a new view of the operating field, theoretically allows more precise performance and can also change decision-making mechanisms during surgery with more precise visual control of some surgical steps.
Interventions
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Intraoperative Optical Coherence Tomography (iOCT)
The use of iOCT during surgery offers the advantage of a new view of the operating field, theoretically allows more precise performance and can also change decision-making mechanisms during surgery with more precise visual control of some surgical steps.
Eligibility Criteria
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Inclusion Criteria
2. Clinical diagnosis of Primary open angle glaucoma and Normotension glaucoma indicated for surgical treatment Deep sclerectomy with implantation of subchoroidal implant Esnoper Clip
3. Clinical diagnosis of Epiretinal membrane indicated for surgical treatment Pars plana vitrectomy with epiretinal membrane peeling
Exclusion Criteria
2. Uveitis in anamnestic history
3. Other ocular diagnosis deteriorating visual acuity (eg. age related macular degeneration, diabetic macular edema, macular scars)
18 Years
ALL
No
Sponsors
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Vascular surgery, University hospital Královské Vinohrady, Prague
OTHER
Somich, s.r.o.
OTHER
Responsible Party
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Tomas Benda, MD, FEBO
Principal Investigator
Locations
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Somich
Karlovy Vary, , Czechia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IOCT2022
Identifier Type: -
Identifier Source: org_study_id
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