Efficiency of Intraoperative Optical Coherence Tomography (iOCT)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Glaucoma; Epiretinal Membrane; Cornea
• Intervention / Treatment: Device: Intraoperative Optical Coherence Tomography (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)

• Study Type: Interventional
• Enrollment (Anticipated): 2
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tomas Benda, MD, FEBO; Phone Number: 00420777618993; Email: tomas.benda@post.cz
• Study Contact Backup: Name: Pavel Studeny, MD, PD, PhD; Phone Number: 00420775555342; Email: studenypavel@seznam.cz

Study Locations

• Czechia
  • Karlovy Vary, Czechia, 36006
    • Recruiting
    • Somich
    • Principal Investigator: Tomas Benda, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Active Comparator: 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.	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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	6 months postoperatively
Density of the transplanted endothelium cells.	The investigators will evaluate the density of the transplanted endothelium cells using the endothelial microscope.	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.	1 month postoperatively
Density of the transplanted endothelium cells.	The investigators will evaluate the density of the transplanted endothelium cells using the endothelial microscope.	3 months postoperatively
Density of the transplanted endothelium cells.	The investigators will evaluate the density of the transplanted endothelium cells using the endothelial microscope.	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.	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.	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.	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.	6 months postoperatively
Frequency of epiretinal membrane residues.	The investigators will evaluate the frequency of epiretinal membrane residues using stationary OCT.	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.	At the first week postoperatively.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammation reaction	The investigators will evaluate intraocular postoperative inflammation reaction using the SUN - standardization of uveitis nomenclature	At the first week postoperatively.
Inflammation reaction	The investigators will evaluate intraocular postoperative inflammation reaction using the SUN - standardization of uveitis nomenclature	1 month postoperatively
Inflammation reaction	The investigators will evaluate intraocular postoperative inflammation reaction using the SUN - standardization of uveitis nomenclature	3 months postoperatively
Inflammation reaction	The investigators will evaluate intraocular postoperative inflammation reaction using the SUN - standardization of uveitis nomenclature	6 months postoperatively
Visual acuity	The investigators will evaluate corrected and uncorrected visual acuity on LogMAR chart.	At the first week postoperatively.
Visual acuity	The investigators will evaluate corrected and uncorrected visual acuity on LogMAR chart.	1 month postoperatively
Visual acuity	The investigators will evaluate corrected and uncorrected visual acuity on LogMAR chart.	3 months postoperatively
Visual acuity	The investigators will evaluate corrected and uncorrected visual acuity on LogMAR chart.	6 months postoperatively
Intraocular pressure	The investigators will evaluate intraocular pressure using non-contact tonometry in mmHg.	At the first week postoperatively.
Intraocular pressure	The investigators will evaluate intraocular pressure using non-contact tonometry in mmHg.	1 month postoperatively
Intraocular pressure	The investigators will evaluate intraocular pressure using non-contact tonometry in mmHg.	3 months postoperatively
Intraocular pressure	The investigators will evaluate intraocular pressure using non-contact tonometry in mmHg.	6 months postoperatively

Collaborators and Investigators

• Sponsor: Somich, s.r.o.
• Collaborators: Vascular surgery, University hospital Královské Vinohrady, Prague

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: January 15, 2022
• First Submitted That Met QC Criteria: January 30, 2022
• First Posted (Actual): February 10, 2022

Study Record Updates

• Last Update Posted (Actual): May 9, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Intraoperative OCT
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Epiretinal Membrane
• Other Study ID Numbers: IOCT2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No