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Efficiency of Intraoperative Optical Coherence Tomography (iOCT)

Primary Purpose

Epiretinal Membrane, Glaucoma, Cornea

Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Intraoperative Optical Coherence Tomography (iOCT)
Sponsored by
Somich, s.r.o.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Epiretinal Membrane focused on measuring Intraoperative OCT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • SomichRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Lamellar corneal transplantation type DMEK

Deep sclerectomy with implantation of subchoroidal implant Esnoper Clip

Pars plana vitrectomy with epiretinal membrane peeling

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
Density of the transplanted endothelium cells.
The investigators will evaluate the density of the transplanted endothelium cells using the endothelial microscope.
Density of the transplanted endothelium cells.
The investigators will evaluate the density of the transplanted endothelium cells using the endothelial microscope.
Density of the transplanted endothelium cells.
The investigators will evaluate the density of the transplanted endothelium cells using the endothelial microscope.
Density of the transplanted endothelium cells.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Inflammation reaction
The investigators will evaluate intraocular postoperative inflammation reaction using the SUN - standardization of uveitis nomenclature
Inflammation reaction
The investigators will evaluate intraocular postoperative inflammation reaction using the SUN - standardization of uveitis nomenclature
Inflammation reaction
The investigators will evaluate intraocular postoperative inflammation reaction using the SUN - standardization of uveitis nomenclature
Inflammation reaction
The investigators will evaluate intraocular postoperative inflammation reaction using the SUN - standardization of uveitis nomenclature
Visual acuity
The investigators will evaluate corrected and uncorrected visual acuity on LogMAR chart.
Visual acuity
The investigators will evaluate corrected and uncorrected visual acuity on LogMAR chart.
Visual acuity
The investigators will evaluate corrected and uncorrected visual acuity on LogMAR chart.
Visual acuity
The investigators will evaluate corrected and uncorrected visual acuity on LogMAR chart.
Intraocular pressure
The investigators will evaluate intraocular pressure using non-contact tonometry in mmHg.
Intraocular pressure
The investigators will evaluate intraocular pressure using non-contact tonometry in mmHg.
Intraocular pressure
The investigators will evaluate intraocular pressure using non-contact tonometry in mmHg.
Intraocular pressure
The investigators will evaluate intraocular pressure using non-contact tonometry in mmHg.

Full Information

First Posted
January 15, 2022
Last Updated
May 3, 2022
Sponsor
Somich, s.r.o.
Collaborators
Vascular surgery, University hospital Královské Vinohrady, Prague
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1. Study Identification

Unique Protocol Identification Number
NCT05232539
Brief Title
Efficiency of Intraoperative Optical Coherence Tomography (iOCT)
Official Title
Efficiency of Intraoperative Optical Coherence Tomography (iOCT) in Eye Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 2022 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Somich, s.r.o.
Collaborators
Vascular surgery, University hospital Královské Vinohrady, Prague

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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). 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: 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 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). Frequency of epiretinal membrane residues (using stationary OCT) Histological verification of tissues identified on the basis of iOCT during surgery (in Deep sclerectomy and Pars plana vitrectomy patients)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epiretinal Membrane, Glaucoma, Cornea
Keywords
Intraoperative OCT

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lamellar corneal transplantation type DMEK
Arm Type
Active Comparator
Arm Description
50 operations, procedure will be randomly divided into 2 subgroups of 25 patients with and without the use of iOCT during the operation.
Arm Title
Deep sclerectomy with implantation of subchoroidal implant Esnoper Clip
Arm Type
Active Comparator
Arm Description
50 operations, procedure will be randomly divided into 2 subgroups of 25 patients with and without the use of iOCT during the operation.
Arm Title
Pars plana vitrectomy with epiretinal membrane peeling
Arm Type
Active Comparator
Arm Description
50 operations, procedure will be randomly divided into 2 subgroups of 25 patients with and without the use of iOCT during the operation.
Intervention Type
Device
Intervention Name(s)
Intraoperative Optical Coherence Tomography (iOCT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Attachment of the transplanted DMEK lamella.
Description
The investigators will evaluate the attachment of the transplanted DMEK lamella (respectively % area of lamella ablation) on the slit lamp.
Time Frame
At the first week postoperatively.
Title
Attachment of the transplanted DMEK lamella.
Description
The investigators will evaluate the attachment of the transplanted DMEK lamella (respectively % area of lamella ablation) on the slit lamp.
Time Frame
1 month postoperatively
Title
Attachment of the transplanted DMEK lamella.
Description
The investigators will evaluate the attachment of the transplanted DMEK lamella (respectively % area of lamella ablation) on the slit lamp.
Time Frame
3 months postoperatively
Title
Attachment of the transplanted DMEK lamella.
Description
The investigators will evaluate the attachment of the transplanted DMEK lamella (respectively % area of lamella ablation) on the slit lamp.
Time Frame
6 months postoperatively
Title
Density of the transplanted endothelium cells.
Description
The investigators will evaluate the density of the transplanted endothelium cells using the endothelial microscope.
Time Frame
At the first week postoperatively.
Title
Density of the transplanted endothelium cells.
Description
The investigators will evaluate the density of the transplanted endothelium cells using the endothelial microscope.
Time Frame
1 month postoperatively
Title
Density of the transplanted endothelium cells.
Description
The investigators will evaluate the density of the transplanted endothelium cells using the endothelial microscope.
Time Frame
3 months postoperatively
Title
Density of the transplanted endothelium cells.
Description
The investigators will evaluate the density of the transplanted endothelium cells using the endothelial microscope.
Time Frame
6 months postoperatively
Title
Correct localization of the Esnoper Clip implant and confirmation of its functionality.
Description
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.
Time Frame
At the first week postoperatively.
Title
Correct localization of the Esnoper Clip implant and confirmation of its functionality.
Description
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.
Time Frame
1 month postoperatively
Title
Correct localization of the Esnoper Clip implant and confirmation of its functionality.
Description
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.
Time Frame
3 months postoperatively
Title
Correct localization of the Esnoper Clip implant and confirmation of its functionality.
Description
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.
Time Frame
6 months postoperatively
Title
Frequency of epiretinal membrane residues.
Description
The investigators will evaluate the frequency of epiretinal membrane residues using stationary OCT.
Time Frame
At the first week postoperatively.
Title
Histological verification of tissues identified on the basis of iOCT during surgery.
Description
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.
Time Frame
At the first week postoperatively.
Secondary Outcome Measure Information:
Title
Inflammation reaction
Description
The investigators will evaluate intraocular postoperative inflammation reaction using the SUN - standardization of uveitis nomenclature
Time Frame
At the first week postoperatively.
Title
Inflammation reaction
Description
The investigators will evaluate intraocular postoperative inflammation reaction using the SUN - standardization of uveitis nomenclature
Time Frame
1 month postoperatively
Title
Inflammation reaction
Description
The investigators will evaluate intraocular postoperative inflammation reaction using the SUN - standardization of uveitis nomenclature
Time Frame
3 months postoperatively
Title
Inflammation reaction
Description
The investigators will evaluate intraocular postoperative inflammation reaction using the SUN - standardization of uveitis nomenclature
Time Frame
6 months postoperatively
Title
Visual acuity
Description
The investigators will evaluate corrected and uncorrected visual acuity on LogMAR chart.
Time Frame
At the first week postoperatively.
Title
Visual acuity
Description
The investigators will evaluate corrected and uncorrected visual acuity on LogMAR chart.
Time Frame
1 month postoperatively
Title
Visual acuity
Description
The investigators will evaluate corrected and uncorrected visual acuity on LogMAR chart.
Time Frame
3 months postoperatively
Title
Visual acuity
Description
The investigators will evaluate corrected and uncorrected visual acuity on LogMAR chart.
Time Frame
6 months postoperatively
Title
Intraocular pressure
Description
The investigators will evaluate intraocular pressure using non-contact tonometry in mmHg.
Time Frame
At the first week postoperatively.
Title
Intraocular pressure
Description
The investigators will evaluate intraocular pressure using non-contact tonometry in mmHg.
Time Frame
1 month postoperatively
Title
Intraocular pressure
Description
The investigators will evaluate intraocular pressure using non-contact tonometry in mmHg.
Time Frame
3 months postoperatively
Title
Intraocular pressure
Description
The investigators will evaluate intraocular pressure using non-contact tonometry in mmHg.
Time Frame
6 months postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tomas Benda, MD, FEBO
Phone
00420777618993
Email
tomas.benda@post.cz
First Name & Middle Initial & Last Name or Official Title & Degree
Pavel Studeny, MD, PD, PhD
Phone
00420775555342
Email
studenypavel@seznam.cz
Facility Information:
Facility Name
Somich
City
Karlovy Vary
ZIP/Postal Code
36006
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pavel Studeny, MD
Phone
00420775555342
Email
studenypavel@seznam.cz
First Name & Middle Initial & Last Name & Degree
Tomas Benda, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficiency of Intraoperative Optical Coherence Tomography (iOCT)

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