NCT05232539

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 9, 2022

Status Verified

May 1, 2022

Enrollment Period

1.6 years

First QC Date

January 15, 2022

Last Update Submit

May 3, 2022

Conditions

Epiretinal MembraneGlaucomaCornea

Keywords

Intraoperative OCT

Outcome Measures

Primary Outcomes (14)

  • 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 Outcomes (12)

  • Inflammation reaction

    At the first week postoperatively.

  • Inflammation reaction

    1 month postoperatively

  • Inflammation reaction

    3 months postoperatively

  • Inflammation reaction

    6 months postoperatively

  • Visual acuity

    At the first week postoperatively.

  • +7 more secondary outcomes

Study Arms (3)

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.

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.

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.

Device: Intraoperative Optical Coherence Tomography (iOCT)

Interventions

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.

Deep sclerectomy with implantation of subchoroidal implant Esnoper ClipLamellar corneal transplantation type DMEKPars plana vitrectomy with epiretinal membrane peeling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Somich

Karlovy Vary, 36006, Czechia

RECRUITING

MeSH Terms

Conditions

Epiretinal MembraneGlaucomaCorneal Diseases

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesOcular Hypertension

Central Study Contacts

Tomas Benda, MD, FEBO

CONTACT

00420777618993tomas.benda@post.cz

Pavel Studeny, MD, PD, PhD

CONTACT

00420775555342studenypavel@seznam.cz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Model Details: 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)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 15, 2022

First Posted

February 10, 2022

Study Start

May 1, 2022

Primary Completion

December 1, 2023

Study Completion

December 31, 2023

Last Updated

May 9, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)