Efficiency of Intraoperative Optical Coherence Tomography (iOCT)

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05232539
• Other study ID #: IOCT2022
• Status: Recruiting
• Phase: N/A
• Start date: May 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2022
• Source: Somich, s.r.o.
• Contact: Tomas Benda, MD, FEBO
• Phone: 00420777618993
• Email: tomas.benda[@]post.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2
• Est. completion date: December 31, 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cornea
• Epiretinal Membrane
• Glaucoma

Intervention

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.

Locations

Country	Name	City	State
Czechia	Somich	Karlovy Vary

Sponsors (2)

Lead Sponsor	Collaborator
Somich, s.r.o.	Vascular surgery, University hospital Královské Vinohrady, Prague

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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
Primary	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
Primary	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
Primary	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.
Primary	Density of the transplanted endothelium cells.	The investigators will evaluate the density of the transplanted endothelium cells using the endothelial microscope.	1 month postoperatively
Primary	Density of the transplanted endothelium cells.	The investigators will evaluate the density of the transplanted endothelium cells using the endothelial microscope.	3 months postoperatively
Primary	Density of the transplanted endothelium cells.	The investigators will evaluate the density of the transplanted endothelium cells using the endothelial microscope.	6 months postoperatively
Primary	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.
Primary	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
Primary	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
Primary	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
Primary	Frequency of epiretinal membrane residues.	The investigators will evaluate the frequency of epiretinal membrane residues using stationary OCT.	At the first week postoperatively.
Primary	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	Inflammation reaction	The investigators will evaluate intraocular postoperative inflammation reaction using the SUN - standardization of uveitis nomenclature	At the first week postoperatively.
Secondary	Inflammation reaction	The investigators will evaluate intraocular postoperative inflammation reaction using the SUN - standardization of uveitis nomenclature	1 month postoperatively
Secondary	Inflammation reaction	The investigators will evaluate intraocular postoperative inflammation reaction using the SUN - standardization of uveitis nomenclature	3 months postoperatively
Secondary	Inflammation reaction	The investigators will evaluate intraocular postoperative inflammation reaction using the SUN - standardization of uveitis nomenclature	6 months postoperatively
Secondary	Visual acuity	The investigators will evaluate corrected and uncorrected visual acuity on LogMAR chart.	At the first week postoperatively.
Secondary	Visual acuity	The investigators will evaluate corrected and uncorrected visual acuity on LogMAR chart.	1 month postoperatively
Secondary	Visual acuity	The investigators will evaluate corrected and uncorrected visual acuity on LogMAR chart.	3 months postoperatively
Secondary	Visual acuity	The investigators will evaluate corrected and uncorrected visual acuity on LogMAR chart.	6 months postoperatively
Secondary	Intraocular pressure	The investigators will evaluate intraocular pressure using non-contact tonometry in mmHg.	At the first week postoperatively.
Secondary	Intraocular pressure	The investigators will evaluate intraocular pressure using non-contact tonometry in mmHg.	1 month postoperatively
Secondary	Intraocular pressure	The investigators will evaluate intraocular pressure using non-contact tonometry in mmHg.	3 months postoperatively
Secondary	Intraocular pressure	The investigators will evaluate intraocular pressure using non-contact tonometry in mmHg.	6 months postoperatively