Meibomian Gland DysfunctionNCT03461978
Ultrahigh-resolution Optical Coherence Tomography Imaging of the Anterior Eye Segment Structures
A study testing Ultrahigh resolution Spectral Domain OCT in people with Meibomian Gland Dysfunction and Cataract, run by Medical University of Vienna at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meibomian Gland Dysfunction, Cataract, Glaucoma
- What is being tested?
- Ultrahigh resolution Spectral Domain OCT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteAustria
- Study dates
- 12 Jul 2017to 16 Jun 2023
- Phase
- Interventional
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
- 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
Show all 14Show fewer
- 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
Who cannot join
- Presence of any abnormalities preventing reliable measurements as judged by the investigator
- Pregnancy, planned pregnancy or lactating
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University Vienna, Department of Clnical Pharmacology
Vienna, State of Vienna, 1090
About this study
Official title: Ultrahigh-resolution Optical Coherence Tomography Imaging of the Anterior Eye Segment Structures - a Pilot Study
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.
- Conditions
- Meibomian Gland Dysfunction, Cataract, Glaucoma, Corneal Transplantation, Demodicosis, Conjunctival Pathologies
- Being tested
- Ultrahigh resolution Spectral Domain OCT
- Medical subject headings
- Meibomian Gland Dysfunction, Cataract, Glaucoma, Acanthamoeba Keratitis, Aniridia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrahigh resolution Spectral Domain OCTDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 10 patients with meibomian gland dysfunction | Other | Not described Receives: Device: Ultrahigh resolution Spectral Domain OCT |
| 10 patients with cataract | Other | Not described Receives: Device: Ultrahigh resolution Spectral Domain OCT |
| 10 patients after minimally invasive glaucoma surgery (MIGS) | Other | Not described Receives: Device: Ultrahigh resolution Spectral Domain OCT |
| 10 patients after partial corneal transplantation | Other | Not described Receives: Device: Ultrahigh resolution Spectral Domain OCT |
| 5 patients with demodicosis | Other | Not described Receives: Device: Ultrahigh resolution Spectral Domain OCT |
| 5 patients with conjunctival pathologies | Other | Not described Receives: Device: Ultrahigh resolution Spectral Domain OCT |
| 5 patients with Acanthamoeba keratitis | Other | Not described Receives: Device: Ultrahigh resolution Spectral Domain OCT |
| 5 patients with aniridia | Other | Not described Receives: Device: Ultrahigh resolution Spectral Domain OCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start12 Jul 2017
- Primary completion16 Jun 2023
- Study completion16 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Meibomian Gland DysfunctionStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerhard Garhofer, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03461978
- Sponsor's protocol ID
- OPHT - 010616
- Status last verified
- Apr 2022
- First submitted
- 2 Jan 2018
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22446717Drexler 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.
PubMed 25079820Werkmeister 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.
PubMed 23847319