Clinical trial NCT05232539: Efficiency of Intraoperative Optical Coherence Tomography (iOCT)
Official title: Efficiency of Intraoperative Optical Coherence Tomography (iOCT) in Eye Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Epiretinal Membrane
Glaucoma
Cornea
Keywords: Intraoperative OCT
Lead sponsor: Somich, s.r.o.
Sponsor class: OTHER
Collaborators: name: Vascular surgery, University hospital Královské Vinohrady, Prague
First posted: 2022-02-10
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, randomized, comparative study conducted at the SOMICH Eye Center s.r.o. in Karlovy Vary, comparing the effectiveness and safety of the use of Intraoperative Optical Coherence Tomography (iOCT)
Primary purpose: DEVICE_FEASIBILITY

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:

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)

Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of Bullous keratopathy and Fuchs dystrophy of the cornea indicated for surgical treatment DMEK
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:

1. If it is not possible to take an iOCT image
2. Uveitis in anamnestic history
3. Other ocular diagnosis deteriorating visual acuity (eg. age related macular degeneration, diabetic macular edema, macular scars)

Primary outcomes:
measure: Attachment of the transplanted DMEK lamella.
timeFrame: At the first week postoperatively.
measure: Attachment of the transplanted DMEK lamella.
timeFrame: 1 month postoperatively
measure: Attachment of the transplanted DMEK lamella.
timeFrame: 3 months postoperatively
measure: Attachment of the transplanted DMEK lamella.
timeFrame: 6 months postoperatively
measure: Density of the transplanted endothelium cells.
timeFrame: At the first week postoperatively.
measure: Density of the transplanted endothelium cells.
timeFrame: 1 month postoperatively
measure: Density of the transplanted endothelium cells.
timeFrame: 3 months postoperatively
measure: Density of the transplanted endothelium cells.
timeFrame: 6 months postoperatively
measure: Correct localization of the Esnoper Clip implant and confirmation of its functionality.
timeFrame: At the first week postoperatively.
measure: Correct localization of the Esnoper Clip implant and confirmation of its functionality.
timeFrame: 1 month postoperatively
measure: Correct localization of the Esnoper Clip implant and confirmation of its functionality.
timeFrame: 3 months postoperatively
measure: Correct localization of the Esnoper Clip implant and confirmation of its functionality.
timeFrame: 6 months postoperatively
measure: Frequency of epiretinal membrane residues.
timeFrame: At the first week postoperatively.
measure: Histological verification of tissues identified on the basis of iOCT during surgery.
timeFrame: At the first week postoperatively.
Secondary outcomes:
measure: Inflammation reaction
timeFrame: At the first week postoperatively.
measure: Inflammation reaction
timeFrame: 1 month postoperatively
measure: Inflammation reaction
timeFrame: 3 months postoperatively
measure: Inflammation reaction
timeFrame: 6 months postoperatively
measure: Visual acuity
timeFrame: At the first week postoperatively.
measure: Visual acuity
timeFrame: 1 month postoperatively
measure: Visual acuity
timeFrame: 3 months postoperatively
measure: Visual acuity
timeFrame: 6 months postoperatively
measure: Intraocular pressure
timeFrame: At the first week postoperatively.
measure: Intraocular pressure
timeFrame: 1 month postoperatively
measure: Intraocular pressure
timeFrame: 3 months postoperatively
measure: Intraocular pressure
timeFrame: 6 months postoperatively
Other outcomes:
Locations:
city: Karlovy Vary
country: Czechia
facility: Somich
Study officials:
References: