Epiretinal MembraneNCT05232539
Efficiency of Intraoperative Optical Coherence Tomography (iOCT)
A study testing Intraoperative Optical Coherence Tomography (iOCT) in people with Epiretinal Membrane and Glaucoma, run by Somich, s.r.o. at 1 site in Czechia.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epiretinal Membrane, Glaucoma, Cornea
- What is being tested?
- Intraoperative Optical Coherence Tomography (iOCT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteCzechia
- Study dates
- May 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Somich
Karlovy Vary, 36006
Pavel Studeny, MD, 00420775555342, studenypavel@seznam.cz
Tomas Benda, MD
About this study
Official title: Efficiency of Intraoperative Optical Coherence Tomography (iOCT) in Eye Surgery
Efficiency of Intraoperative Optical Coherence Tomography (iOCT)
Hypothesis:
Read more
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.
Read the 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)
- Conditions
- Epiretinal Membrane, Glaucoma, Cornea
- Being tested
- Intraoperative Optical Coherence Tomography (iOCT)
- Keywords
- Intraoperative OCT
- Medical subject headings
- Epiretinal Membrane, Glaucoma, Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative Optical Coherence Tomography (iOCT)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Lamellar corneal transplantation type DMEK | Active comparator | 50 operations, procedure will be randomly divided into 2 subgroups of 25 patients with and without the use of iOCT during the operation. Receives: Device: Intraoperative Optical Coherence Tomography (iOCT) |
| Deep sclerectomy with implantation of subchoroidal implant Esnoper Clip | Active comparator | 50 operations, procedure will be randomly divided into 2 subgroups of 25 patients with and without the use of iOCT during the operation. Receives: Device: Intraoperative Optical Coherence Tomography (iOCT) |
| Pars plana vitrectomy with epiretinal membrane peeling | Active comparator | 50 operations, procedure will be randomly divided into 2 subgroups of 25 patients with and without the use of iOCT during the operation. Receives: Device: Intraoperative Optical Coherence Tomography (iOCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months postoperatively
Density of the transplanted endothelium cells.
The investigators will evaluate the density of the transplanted endothelium cells using the endothelial microscope.
Measured: 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.
Measured: 1 month postoperatively
Density of the transplanted endothelium cells.
The investigators will evaluate the density of the transplanted endothelium cells using the endothelial microscope.
Measured: 3 months postoperatively
Density of the transplanted endothelium cells.
The investigators will evaluate the density of the transplanted endothelium cells using the endothelial microscope.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months postoperatively
Frequency of epiretinal membrane residues.
The investigators will evaluate the frequency of epiretinal membrane residues using stationary OCT.
Measured: 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.
Measured: At the first week postoperatively.
Secondary outcomes (12)
Inflammation reaction
The investigators will evaluate intraocular postoperative inflammation reaction using the SUN - standardization of uveitis nomenclature
Measured: At the first week postoperatively.
Inflammation reaction
The investigators will evaluate intraocular postoperative inflammation reaction using the SUN - standardization of uveitis nomenclature
Measured: 1 month postoperatively
Inflammation reaction
The investigators will evaluate intraocular postoperative inflammation reaction using the SUN - standardization of uveitis nomenclature
Measured: 3 months postoperatively
Inflammation reaction
The investigators will evaluate intraocular postoperative inflammation reaction using the SUN - standardization of uveitis nomenclature
Measured: 6 months postoperatively
Visual acuity
The investigators will evaluate corrected and uncorrected visual acuity on LogMAR chart.
Measured: At the first week postoperatively.
Visual acuity
The investigators will evaluate corrected and uncorrected visual acuity on LogMAR chart.
Measured: 1 month postoperatively
Visual acuity
The investigators will evaluate corrected and uncorrected visual acuity on LogMAR chart.
Measured: 3 months postoperatively
Visual acuity
The investigators will evaluate corrected and uncorrected visual acuity on LogMAR chart.
Measured: 6 months postoperatively
Intraocular pressure
The investigators will evaluate intraocular pressure using non-contact tonometry in mmHg.
Measured: At the first week postoperatively.
Intraocular pressure
The investigators will evaluate intraocular pressure using non-contact tonometry in mmHg.
Measured: 1 month postoperatively
Intraocular pressure
The investigators will evaluate intraocular pressure using non-contact tonometry in mmHg.
Measured: 3 months postoperatively
Intraocular pressure
The investigators will evaluate intraocular pressure using non-contact tonometry in mmHg.
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study startMay 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epiretinal MembraneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Somich, s.r.o.
- Sponsor type
- University, hospital or other
- Collaborators
- Vascular surgery, University hospital Královské Vinohrady, Prague
- Responsible party
- Principal investigator, Tomas Benda, MD, FEBO, Somich, s.r.o.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05232539
- Sponsor's protocol ID
- IOCT2022
- Status last verified
- May 2022
- First submitted
- 15 Jan 2022
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Intraoperative Optical Coherence Tomography (iOCT) in Eye Surgery
- ClinicalTrials.gov ID
- NCT05232539
- Acronym / sponsor ID
- IOCT2022
- Conditions
- Epiretinal Membrane, Glaucoma, Cornea
- Keywords
- Intraoperative OCT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Somich, s.r.o.University, hospital or other
- Collaborators
- Vascular surgery, University hospital Královské Vinohrady, Prague
- Study start
- May 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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)
| Arm | Type | Receives |
|---|---|---|
| Lamellar corneal transplantation type DMEK | Active comparator | Device: Intraoperative Optical Coherence Tomography (iOCT)50 operations, procedure will be randomly divided into 2 subgroups of 25 patients with and without the use of iOCT during the operation. |
| Deep sclerectomy with implantation of subchoroidal implant Esnoper Clip | Active comparator | Device: Intraoperative Optical Coherence Tomography (iOCT)50 operations, procedure will be randomly divided into 2 subgroups of 25 patients with and without the use of iOCT during the operation. |
| Pars plana vitrectomy with epiretinal membrane peeling | Active comparator | Device: Intraoperative Optical Coherence Tomography (iOCT)50 operations, procedure will be randomly divided into 2 subgroups of 25 patients with and without the use of iOCT during the operation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Deep sclerectomy with implantation of subchoroidal implant Esnoper Clip, Lamellar corneal transplantation type DMEK, Pars plana vitrectomy with epiretinal membrane peeling |
Primary outcome
Attachment of the transplanted DMEK lamella.
Time frame: At the first week postoperatively.
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.
Time frame: 1 month postoperatively
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.
Time frame: 3 months postoperatively
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.
Time frame: 6 months postoperatively
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.
Time frame: At the first week postoperatively.
The investigators will evaluate the density of the transplanted endothelium cells using the endothelial microscope.
Density of the transplanted endothelium cells.
Time frame: 1 month postoperatively
The investigators will evaluate the density of the transplanted endothelium cells using the endothelial microscope.
Density of the transplanted endothelium cells.
Time frame: 3 months postoperatively
The investigators will evaluate the density of the transplanted endothelium cells using the endothelial microscope.
Density of the transplanted endothelium cells.
Time frame: 6 months postoperatively
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.
Time frame: At the first week postoperatively.
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.
Time frame: 1 month postoperatively
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.
Time frame: 3 months postoperatively
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.
Time frame: 6 months postoperatively
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.
Time frame: At the first week postoperatively.
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.
Time frame: At the first week postoperatively.
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.
12 secondary outcomes
Inflammation reaction
Time frame: At the first week postoperatively.
Inflammation reaction
Time frame: 1 month postoperatively
Inflammation reaction
Time frame: 3 months postoperatively
Inflammation reaction
Time frame: 6 months postoperatively
Visual acuity
Time frame: At the first week postoperatively.
Visual acuity
Time frame: 1 month postoperatively
Visual acuity
Time frame: 3 months postoperatively
Visual acuity
Time frame: 6 months postoperatively
Intraocular pressure
Time frame: At the first week postoperatively.
Intraocular pressure
Time frame: 1 month postoperatively
Intraocular pressure
Time frame: 3 months postoperatively
Intraocular pressure
Time frame: 6 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative Optical Coherence Tomography (iOCT) in people with Epiretinal Membrane and Glaucoma, run by Somich, s.r.o. at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tomas Benda, MD, FEBO (00420777618993, tomas.benda@post.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attachment of the transplanted DMEK lamella. (time frame: At the first week postoperatively.). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2022.