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CompletedNCT03461978Updated May 23, 2025

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

An interventional study of Ultrahigh resolution Spectral Domain OCT in Meibomian Gland Dysfunction, Cataract and Glaucoma, sponsored by Medical University of Vienna. Completed at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-23.

Sponsored by Medical University of Vienna · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Jul 2017, registered Jan 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Meibomian Gland Dysfunction
  • Cataract
  • Glaucoma
  • Corneal Transplantation
  • Demodicosis
  • Conjunctival Pathologies
  • Acanthamoeba Keratitis
  • Aniridia
03

In context

Meibomian Gland Dysfunction

172 studies on the registry are indexed under Meibomian Gland Dysfunction; 23 are open to participants now.

This study's enrollment of 14 is below the median of 50 across 138 interventional studies indexed under Meibomian Gland Dysfunction.

Browse Meibomian Gland Dysfunction studies →

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,109 studies on the registry; 184 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Presence of any abnormalities preventing reliable measurements as judged by the investigator
  • Pregnancy, planned pregnancy or lactating
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Other
    10 patients with meibomian gland dysfunction

    Device: Ultrahigh resolution Spectral Domain OCT

  • Other
    10 patients with cataract

    Device: Ultrahigh resolution Spectral Domain OCT

  • Other
    10 patients after minimally invasive glaucoma surgery (MIGS)

    Device: Ultrahigh resolution Spectral Domain OCT

  • Other
    10 patients after partial corneal transplantation

    Device: Ultrahigh resolution Spectral Domain OCT

  • Other
    5 patients with demodicosis

    Device: Ultrahigh resolution Spectral Domain OCT

  • Other
    5 patients with conjunctival pathologies

    Device: Ultrahigh resolution Spectral Domain OCT

  • Other
    5 patients with Acanthamoeba keratitis

    Device: Ultrahigh resolution Spectral Domain OCT

  • Other
    5 patients with aniridia

    Device: Ultrahigh resolution Spectral Domain OCT

Interventions

  • DeviceUltrahigh resolution Spectral Domain OCT

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 60 minutes

07

Study locations

1 site
  • Medical University Vienna, Department of Clnical Pharmacology
    Vienna, 1090, Austria
08

References and documents

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 22446717 ↗
  • 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. PubMed 25079820 ↗
  • 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. PubMed 23847319 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2017 to primary completion in Jun 2023, 71 months.

Of 52 non-industry interventional studies with no phase under Meibomian Gland Dysfunction, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 27. This study's 71 months is above that.

Counting every sponsor, half of 74 studies reached it within 11 months; a quarter within 5 and three quarters within 19.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 2, 2018
First posted
Mar 12, 2018
StartActual
Jul 12, 2017
Primary completionActual
Jun 16, 2023
CompletionActual
Jun 16, 2023
Last update
May 23, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03461978
Responsible party
Gerhard Garhofer (Assoc. Prof. Priv.-Doz. Dr., Medical University of Vienna) — Principal investigator
First posted
Mar 12, 2018
Start date
Jul 12, 2017
Primary completion
Jun 16, 2023
Completion
Jun 16, 2023
Last update
May 23, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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