NCT05232539

Efficiency of Intraoperative Optical Coherence Tomography (iOCT)

Efficiency of Intraoperative Optical Coherence Tomography (iOCT) in Eye Surgery

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (estimated)
• Sponsor: Somich, s.r.o. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Epiretinal Membrane
• Glaucoma
• Cornea

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-05-01
• Primary completion: 2023-12-01
• Completion: 2023-12-31
• First posted: 2022-02-10
• Last updated: 2022-05-09

Locations

1 site across 1 country: Czechia

Regulatory

• FDA-regulated device study