Efficiency of Intraoperative Optical Coherence Tomography (iOCT)

Somich, s.r.o.

Status: Unknown

Conditions: Glaucoma; Epiretinal Membrane; Cornea

Treatments: Device: Intraoperative Optical Coherence Tomography (iOCT)

Study type: Interventional

Funder types: Other

Identifiers

NCT05232539

IOCT2022

Details and patient eligibility

About

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.

Full 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)

Enrollment: 2 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 3 patient groups

Lamellar corneal transplantation type DMEK

Active Comparator group

Description:

50 operations, procedure will be randomly divided into 2 subgroups of 25 patients with and without the use of iOCT during the operation.

Treatment:

Device: Intraoperative Optical Coherence Tomography (iOCT)

Deep sclerectomy with implantation of subchoroidal implant Esnoper Clip

Active Comparator group

Description:

50 operations, procedure will be randomly divided into 2 subgroups of 25 patients with and without the use of iOCT during the operation.

Treatment:

Device: Intraoperative Optical Coherence Tomography (iOCT)

Pars plana vitrectomy with epiretinal membrane peeling

Active Comparator group

Description:

50 operations, procedure will be randomly divided into 2 subgroups of 25 patients with and without the use of iOCT during the operation.

Treatment:

Device: Intraoperative Optical Coherence Tomography (iOCT)