Efficiency of Intraoperative Optical Coherence Tomography (iOCT) in Eye Surgery
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Somich, s.r.o.
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Attachment of the transplanted DMEK lamella.
Study Overview
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.
Detailed Description
Methods:
The effectiveness of iOCT use will be monitored in three types of microsurgical eye surgery:
- Lamellar corneal transplantation type DMEK
- Antiglaucoma surgery - Deep sclerectomy with implantation of subchoroidal implant Esnoper Clip
- 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinical diagnosis of Bullous keratopathy and Fuchs dystrophy of the cornea indicated for surgical treatment DMEK
- •Clinical diagnosis of Primary open angle glaucoma and Normotension glaucoma indicated for surgical treatment Deep sclerectomy with implantation of subchoroidal implant Esnoper Clip
- •Clinical diagnosis of Epiretinal membrane indicated for surgical treatment Pars plana vitrectomy with epiretinal membrane peeling
Exclusion Criteria
- •If it is not possible to take an iOCT image
- •Uveitis in anamnestic history
- •Other ocular diagnosis deteriorating visual acuity (eg. age related macular degeneration, diabetic macular edema, macular scars)
Arms & Interventions
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.
Intervention: Intraoperative Optical Coherence Tomography (iOCT) (Device)
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.
Intervention: Intraoperative Optical Coherence Tomography (iOCT) (Device)
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.
Intervention: Intraoperative Optical Coherence Tomography (iOCT) (Device)
Outcomes
Primary Outcomes
Attachment of the transplanted DMEK lamella.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Attachment of the transplanted DMEK lamella.
Time Frame: 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.
Time Frame: 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.
Time Frame: 3 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.
Time Frame: 3 months postoperatively
The investigators will evaluate the density of the transplanted endothelium cells using the endothelial microscope.
Density of the transplanted endothelium cells.
Time Frame: 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.
Time Frame: 1 month 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Secondary Outcomes
- Inflammation reaction(6 months postoperatively)
- Visual acuity(6 months postoperatively)
- Intraocular pressure(6 months postoperatively)
- Inflammation reaction(At the first week postoperatively.)
- Inflammation reaction(1 month postoperatively)
- Inflammation reaction(3 months postoperatively)
- Visual acuity(At the first week postoperatively.)
- Visual acuity(1 month postoperatively)
- Visual acuity(3 months postoperatively)
- Intraocular pressure(At the first week postoperatively.)
- Intraocular pressure(1 month postoperatively)
- Intraocular pressure(3 months postoperatively)
Investigators
Tomas Benda, MD, FEBO
Principal Investigator
Somich, s.r.o.