Efficiency of Intraoperative Optical Coherence Tomography (iOCT)
Study Details
Study Description
Brief Summary
Efficiency of Intraoperative Optical Coherence Tomography (iOCT)
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Methods:
The effectiveness of iOCT use will be monitored in three types of microsurgical eye surgery:
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Lamellar corneal transplantation type DMEK
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Antiglaucoma surgery - Deep sclerectomy with implantation of subchoroidal implant Esnoper Clip
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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:
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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
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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).
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Frequency of epiretinal membrane residues (using stationary OCT)
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Histological verification of tissues identified on the basis of iOCT during surgery (in Deep sclerectomy and Pars plana vitrectomy patients)
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 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. |
Device: 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.
|
| Active Comparator: 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. |
Device: 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.
|
| Active Comparator: 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. |
Device: 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.
|
Outcome Measures
Primary Outcome Measures
- Attachment of the transplanted DMEK lamella. [At the first week postoperatively.]
The investigators will evaluate the attachment of the transplanted DMEK lamella (respectively % area of lamella ablation) on the slit lamp.
- Attachment of the transplanted DMEK lamella. [1 month postoperatively]
The investigators will evaluate the attachment of the transplanted DMEK lamella (respectively % area of lamella ablation) on the slit lamp.
- Attachment of the transplanted DMEK lamella. [3 months postoperatively]
The investigators will evaluate the attachment of the transplanted DMEK lamella (respectively % area of lamella ablation) on the slit lamp.
- Attachment of the transplanted DMEK lamella. [6 months postoperatively]
The investigators will evaluate the attachment of the transplanted DMEK lamella (respectively % area of lamella ablation) on the slit lamp.
- Density of the transplanted endothelium cells. [At the first week postoperatively.]
The investigators will evaluate the density of the transplanted endothelium cells using the endothelial microscope.
- Density of the transplanted endothelium cells. [1 month postoperatively]
The investigators will evaluate the density of the transplanted endothelium cells using the endothelial microscope.
- Density of the transplanted endothelium cells. [3 months postoperatively]
The investigators will evaluate the density of the transplanted endothelium cells using the endothelial microscope.
- Density of the transplanted endothelium cells. [6 months postoperatively]
The investigators will evaluate the density of the transplanted endothelium cells using the endothelial microscope.
- Correct localization of the Esnoper Clip implant and confirmation of its functionality. [At the first week postoperatively.]
The investigators will evaluate 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.
- Correct localization of the Esnoper Clip implant and confirmation of its functionality. [1 month postoperatively]
The investigators will evaluate 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.
- Correct localization of the Esnoper Clip implant and confirmation of its functionality. [3 months postoperatively]
The investigators will evaluate 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.
- Correct localization of the Esnoper Clip implant and confirmation of its functionality. [6 months postoperatively]
The investigators will evaluate 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.
- Frequency of epiretinal membrane residues. [At the first week postoperatively.]
The investigators will evaluate the frequency of epiretinal membrane residues using stationary OCT.
- Histological verification of tissues identified on the basis of iOCT during surgery. [At the first week postoperatively.]
The investigators in cooperation with pathologist will histologicaly verificate tissues identified on the basis of iOCT during surgery in Deep sclerectomy and Pars plana vitrectomy patients.
Secondary Outcome Measures
- Inflammation reaction [At the first week postoperatively.]
The investigators will evaluate intraocular postoperative inflammation reaction using the SUN - standardization of uveitis nomenclature
- Inflammation reaction [1 month postoperatively]
The investigators will evaluate intraocular postoperative inflammation reaction using the SUN - standardization of uveitis nomenclature
- Inflammation reaction [3 months postoperatively]
The investigators will evaluate intraocular postoperative inflammation reaction using the SUN - standardization of uveitis nomenclature
- Inflammation reaction [6 months postoperatively]
The investigators will evaluate intraocular postoperative inflammation reaction using the SUN - standardization of uveitis nomenclature
- Visual acuity [At the first week postoperatively.]
The investigators will evaluate corrected and uncorrected visual acuity on LogMAR chart.
- Visual acuity [1 month postoperatively]
The investigators will evaluate corrected and uncorrected visual acuity on LogMAR chart.
- Visual acuity [3 months postoperatively]
The investigators will evaluate corrected and uncorrected visual acuity on LogMAR chart.
- Visual acuity [6 months postoperatively]
The investigators will evaluate corrected and uncorrected visual acuity on LogMAR chart.
- Intraocular pressure [At the first week postoperatively.]
The investigators will evaluate intraocular pressure using non-contact tonometry in mmHg.
- Intraocular pressure [1 month postoperatively]
The investigators will evaluate intraocular pressure using non-contact tonometry in mmHg.
- Intraocular pressure [3 months postoperatively]
The investigators will evaluate intraocular pressure using non-contact tonometry in mmHg.
- Intraocular pressure [6 months postoperatively]
The investigators will evaluate intraocular pressure using non-contact tonometry in mmHg.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Clinical diagnosis of Bullous keratopathy and Fuchs dystrophy of the cornea indicated for surgical treatment DMEK
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Clinical diagnosis of Primary open angle glaucoma and Normotension glaucoma indicated for surgical treatment Deep sclerectomy with implantation of subchoroidal implant Esnoper Clip
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Clinical diagnosis of Epiretinal membrane indicated for surgical treatment Pars plana vitrectomy with epiretinal membrane peeling
Exclusion Criteria:
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If it is not possible to take an iOCT image
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Uveitis in anamnestic history
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Other ocular diagnosis deteriorating visual acuity (eg. age related macular degeneration, diabetic macular edema, macular scars)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Somich | Karlovy Vary | Czechia | 36006 |
Sponsors and Collaborators
- Somich, s.r.o.
- Vascular surgery, University hospital Královské Vinohrady, Prague
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IOCT2022