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Ultrahigh-resolution Optical Coherence Tomography Imaging of the Anterior Eye Segment Structures

Primary Purpose

Meibomian Gland Dysfunction, Cataract, Glaucoma

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Ultrahigh resolution Spectral Domain OCT
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Meibomian Gland Dysfunction

Eligibility Criteria

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

Inclusion Criteria:

  • For patients with meibomian gland dysfunction (MGD):

MGD as evidenced by clinical features and gland expression (MGD Grading Scheme, Appendix I (Opitz, Harthan et al. 2015))

  • For cataract patients:

Cataract as evidenced from slit lamp examination, stage range between NII-NIII, CII-CIV, PII-PIII according to The Lens Opacity Classification System II (LOCS II) (Chylack, Leske et al. 1989) (Appendix II)

  • For patients after minimally invasive glaucoma surgery (MIGS):

Patients with history of MIGS secondary to glaucoma

  • For patients with demodicosis:

Demodicosis as evidenced from slit lamp examination and presence of Demodex confirmed by microscopic examination of the eye lashes (Liu, Sheha et al. 2010)

  • For patients with conjunctival pathologies (cyst, naevus, pterygium):

Conjunctival pathologies with a clinical diagnosis of the respective

  • For patients with Acanthamoeba keratitis:

Acanthamoeba keratitis as evidenced from slit lamp examination and confirmed by polymerase chain reaction (PCR) analysis of corneal epithelial and tear samples and culture isolation (Lehmann, Green et al. 1998)

  • For aniridia patients:

Anirida as evidenced from slit lamp examination

Exclusion Criteria:

  • Presence of any abnormalities preventing reliable measurements as judged by the investigator
  • Pregnancy, planned pregnancy or lactating

Sites / Locations

  • Medical University Vienna, Department of Clnical Pharmacology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Other

Other

Other

Other

Other

Other

Other

Other

Arm Label

10 patients with meibomian gland dysfunction

10 patients with cataract

10 patients after minimally invasive glaucoma surgery (MIGS)

10 patients after partial corneal transplantation

5 patients with demodicosis

5 patients with conjunctival pathologies

5 patients with Acanthamoeba keratitis

5 patients with aniridia

Arm Description

Outcomes

Primary Outcome Measures

Measurement of corneal layers in ultrahigh-resolution OCT
Measurement of corneal layers in ultrahigh-resolution OCT of eyes with pathological changes in structures of the anterior eye segment.

Secondary Outcome Measures

Full Information

First Posted
January 2, 2018
Last Updated
April 6, 2022
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT03461978
Brief Title
Ultrahigh-resolution Optical Coherence Tomography Imaging of the Anterior Eye Segment Structures
Official Title
Ultrahigh-resolution Optical Coherence Tomography Imaging of the Anterior Eye Segment Structures - a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 12, 2017 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

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

5. Study Description

Brief Summary
The development of optical coherence tomography (OCT) and its application for in vivo imaging has opened entirely new opportunities in ophthalmology. The technology allows for both noninvasive visualization of the morphology and measurement of functional parameters within ocular tissues to a depth of a few millimetres even in nontransparent media. Until now the resolution of commercially available OCT systems is, however, much lower than that provided by light microscopy. Recently, an ultrahigh-resolution OCT system was developed by our group providing resolutions of 1.7 and 17 µm in axial and lateral direction, respectively. This axial resolution is about four times better than that provided by standard OCT systems. It allows to perform in vivo imaging with a resolution close to biopsy of tissue and to visualize structures of the anterior eye segment with a remarkable richness of detail. The prototype was applied for in vivo imaging of the cornea including the precorneal tear film. The goal of the planned pilot study is to apply this innovative imaging modality for visualization of the ultrastructure of the different parts of the anterior eye segment structures in diseased subjects, as well as in patients who underwent minimally invasive glaucoma surgery (MIGS). The obtained in vivo cross sectional images and three-dimensional data sets are hoped for contributing to the knowledge about the anatomy and physiology of the corresponding tissues. This could allow for a better interpretation of clinical features and findings obtained in slit lamp examination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meibomian Gland Dysfunction, Cataract, Glaucoma, Corneal Transplantation, Demodicosis, Conjunctival Pathologies, Acanthamoeba Keratitis, Aniridia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
10 patients with meibomian gland dysfunction
Arm Type
Other
Arm Title
10 patients with cataract
Arm Type
Other
Arm Title
10 patients after minimally invasive glaucoma surgery (MIGS)
Arm Type
Other
Arm Title
10 patients after partial corneal transplantation
Arm Type
Other
Arm Title
5 patients with demodicosis
Arm Type
Other
Arm Title
5 patients with conjunctival pathologies
Arm Type
Other
Arm Title
5 patients with Acanthamoeba keratitis
Arm Type
Other
Arm Title
5 patients with aniridia
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Ultrahigh resolution Spectral Domain OCT
Intervention Description
A spectrometer based ultrahigh resolution Spectral Domain OCT (SDOCT) system operating at 800 nm for the anterior chamber will be employed in the present study. The spectrum of the Ti:Sapphire laser light source is centered at 800 nm. With a full width at half maximum bandwidth of 170 nm, the axial resolution is 1.3 μm in the cornea. The transverse resolution of the employed OCT system is 21 μm at the front surface of the cornea. For measurement, patients will place their head in a modified slit lamp head rest. During the measurement period, patients will be asked to look straight forward onto an internal fixation target and to avoid blinking. Different scattering patterns, e.g. raster, circular and spiral scans will be employed.
Primary Outcome Measure Information:
Title
Measurement of corneal layers in ultrahigh-resolution OCT
Description
Measurement of corneal layers in ultrahigh-resolution OCT of eyes with pathological changes in structures of the anterior eye segment.
Time Frame
60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: For patients with meibomian gland dysfunction (MGD): MGD as evidenced by clinical features and gland expression (MGD Grading Scheme, Appendix I (Opitz, Harthan et al. 2015)) For cataract patients: Cataract as evidenced from slit lamp examination, stage range between NII-NIII, CII-CIV, PII-PIII according to The Lens Opacity Classification System II (LOCS II) (Chylack, Leske et al. 1989) (Appendix II) For patients after minimally invasive glaucoma surgery (MIGS): Patients with history of MIGS secondary to glaucoma For patients with demodicosis: Demodicosis as evidenced from slit lamp examination and presence of Demodex confirmed by microscopic examination of the eye lashes (Liu, Sheha et al. 2010) For patients with conjunctival pathologies (cyst, naevus, pterygium): Conjunctival pathologies with a clinical diagnosis of the respective For patients with Acanthamoeba keratitis: Acanthamoeba keratitis as evidenced from slit lamp examination and confirmed by polymerase chain reaction (PCR) analysis of corneal epithelial and tear samples and culture isolation (Lehmann, Green et al. 1998) For aniridia patients: Anirida as evidenced from slit lamp examination Exclusion Criteria: Presence of any abnormalities preventing reliable measurements as judged by the investigator Pregnancy, planned pregnancy or lactating
Facility Information:
Facility Name
Medical University Vienna, Department of Clnical Pharmacology
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
22446717
Citation
Wojtkowski M, Kaluzny B, Zawadzki RJ. New directions in ophthalmic optical coherence tomography. Optom Vis Sci. 2012 May;89(5):524-42. doi: 10.1097/OPX.0b013e31824eecb2.
Results Reference
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PubMed Identifier
25079820
Citation
Drexler W, Liu M, Kumar A, Kamali T, Unterhuber A, Leitgeb RA. Optical coherence tomography today: speed, contrast, and multimodality. J Biomed Opt. 2014;19(7):071412. doi: 10.1117/1.JBO.19.7.071412.
Results Reference
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PubMed Identifier
23847319
Citation
Werkmeister RM, Alex A, Kaya S, Unterhuber A, Hofer B, Riedl J, Bronhagl M, Vietauer M, Schmidl D, Schmoll T, Garhofer G, Drexler W, Leitgeb RA, Groeschl M, Schmetterer L. Measurement of tear film thickness using ultrahigh-resolution optical coherence tomography. Invest Ophthalmol Vis Sci. 2013 Aug 15;54(8):5578-83. doi: 10.1167/iovs.13-11920.
Results Reference
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Ultrahigh-resolution Optical Coherence Tomography Imaging of the Anterior Eye Segment Structures

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