An interventional study of Intraoperative Optical Coherence Tomography (iOCT) in Epiretinal Membrane, Glaucoma and Cornea, sponsored by Somich, s.r.o.. Status unknown at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-09.
Sponsored by Somich, s.r.o. · Not applicable, Interventional, and Device feasibility
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.
Methods:
The effectiveness of iOCT use will be monitored in three types of microsurgical eye surgery:
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:
120 studies on the registry are indexed under Epiretinal Membrane; 14 are open to participants now.
This study's planned enrollment of 2 is below the median of 50 across 73 interventional studies indexed under Epiretinal Membrane.
Browse Epiretinal Membrane studies →This is the only study on the registry with Somich, s.r.o. as lead sponsor.
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Exclusion Criteria:
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)
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)
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.
Attachment of the transplanted DMEK lamella.
The investigators will evaluate the attachment of the transplanted DMEK lamella (respectively % area of lamella ablation) on the slit lamp.
Time frame: At the first week postoperatively.
Attachment of the transplanted DMEK lamella.
The investigators will evaluate the attachment of the transplanted DMEK lamella (respectively % area of lamella ablation) on the slit lamp.
Time frame: 1 month postoperatively
Attachment of the transplanted DMEK lamella.
The investigators will evaluate the attachment of the transplanted DMEK lamella (respectively % area of lamella ablation) on the slit lamp.
Time frame: 3 months postoperatively
Attachment of the transplanted DMEK lamella.
The investigators will evaluate the attachment of the transplanted DMEK lamella (respectively % area of lamella ablation) on the slit lamp.
Time frame: 6 months postoperatively
Density of the transplanted endothelium cells.
The investigators will evaluate the density of the transplanted endothelium cells using the endothelial microscope.
Time frame: At the first week postoperatively.
Density of the transplanted endothelium cells.
The investigators will evaluate the density of the transplanted endothelium cells using the endothelial microscope.
Time frame: 1 month postoperatively
Density of the transplanted endothelium cells.
The investigators will evaluate the density of the transplanted endothelium cells using the endothelial microscope.
Time frame: 3 months postoperatively
Density of the transplanted endothelium cells.
The investigators will evaluate the density of the transplanted endothelium cells using the endothelial microscope.
Time frame: 6 months postoperatively
Correct localization of the Esnoper Clip implant and confirmation of its functionality.
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.
Time frame: At the first week postoperatively.
Correct localization of the Esnoper Clip implant and confirmation of its functionality.
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.
Time frame: 1 month postoperatively
Correct localization of the Esnoper Clip implant and confirmation of its functionality.
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.
Time frame: 3 months postoperatively
Correct localization of the Esnoper Clip implant and confirmation of its functionality.
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.
Time frame: 6 months postoperatively
Frequency of epiretinal membrane residues.
The investigators will evaluate the frequency of epiretinal membrane residues using stationary OCT.
Time frame: At the first week postoperatively.
Histological verification of tissues identified on the basis of iOCT during surgery.
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.
Time frame: At the first week postoperatively.
Inflammation reaction
The investigators will evaluate intraocular postoperative inflammation reaction using the SUN - standardization of uveitis nomenclature
Time frame: At the first week postoperatively.
Inflammation reaction
The investigators will evaluate intraocular postoperative inflammation reaction using the SUN - standardization of uveitis nomenclature
Time frame: 1 month postoperatively
Inflammation reaction
The investigators will evaluate intraocular postoperative inflammation reaction using the SUN - standardization of uveitis nomenclature
Time frame: 3 months postoperatively
Inflammation reaction
The investigators will evaluate intraocular postoperative inflammation reaction using the SUN - standardization of uveitis nomenclature
Time frame: 6 months postoperatively
Visual acuity
The investigators will evaluate corrected and uncorrected visual acuity on LogMAR chart.
Time frame: At the first week postoperatively.
Visual acuity
The investigators will evaluate corrected and uncorrected visual acuity on LogMAR chart.
Time frame: 1 month postoperatively
Visual acuity
The investigators will evaluate corrected and uncorrected visual acuity on LogMAR chart.
Time frame: 3 months postoperatively
Visual acuity
The investigators will evaluate corrected and uncorrected visual acuity on LogMAR chart.
Time frame: 6 months postoperatively
Intraocular pressure
The investigators will evaluate intraocular pressure using non-contact tonometry in mmHg.
Time frame: At the first week postoperatively.
Intraocular pressure
The investigators will evaluate intraocular pressure using non-contact tonometry in mmHg.
Time frame: 1 month postoperatively
Intraocular pressure
The investigators will evaluate intraocular pressure using non-contact tonometry in mmHg.
Time frame: 3 months postoperatively
Intraocular pressure
The investigators will evaluate intraocular pressure using non-contact tonometry in mmHg.
Time frame: 6 months postoperatively
Plan to share: No
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