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

NCT03461978 | Completed DMC

• 1 other identifier: OPHT - 010616
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

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.

  60 minutes

Study Arms (8)

10 patients with meibomian gland dysfunction

OTHER

Device: Ultrahigh resolution Spectral Domain OCT

10 patients with cataract

OTHER

Device: Ultrahigh resolution Spectral Domain OCT

10 patients after minimally invasive glaucoma surgery (MIGS)

OTHER

Device: Ultrahigh resolution Spectral Domain OCT

10 patients after partial corneal transplantation

OTHER

Device: Ultrahigh resolution Spectral Domain OCT

5 patients with demodicosis

OTHER

Device: Ultrahigh resolution Spectral Domain OCT

5 patients with conjunctival pathologies

OTHER

Device: Ultrahigh resolution Spectral Domain OCT

5 patients with Acanthamoeba keratitis

OTHER

Device: Ultrahigh resolution Spectral Domain OCT

5 patients with aniridia

OTHER

Device: Ultrahigh resolution Spectral Domain OCT

Interventions

Ultrahigh resolution Spectral Domain OCT DEVICE

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.

10 patients after minimally invasive glaucoma surgery (MIGS); 10 patients after partial corneal transplantation; 10 patients with cataract; 10 patients with meibomian gland dysfunction; 5 patients with Acanthamoeba keratitis; 5 patients with aniridia; 5 patients with conjunctival pathologies; 5 patients with demodicosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University Vienna, Department of Clnical Pharmacology

Vienna, Vienna, 1090, Austria

Location

Related Publications (3)

• 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.

  PMID: 22446717 BACKGROUND

• 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.

  PMID: 25079820 BACKGROUND

• 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.

  PMID: 23847319 BACKGROUND

MeSH Terms

Conditions

Meibomian Gland Dysfunction; Cataract; Glaucoma; Acanthamoeba Keratitis; Aniridia

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Lens Diseases; Ocular Hypertension; Eye Infections, Parasitic; Parasitic Diseases; Infections; Amebiasis; Protozoan Infections; Keratitis; Corneal Diseases; Eye Infections; Eye Abnormalities; Eye Diseases, Hereditary; Iris Diseases; Uveal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Priv.-Doz. Dr.

Study Record Dates

• First Submitted: January 2, 2018
• First Posted: March 12, 2018
• Study Start: July 12, 2017
• Primary Completion: June 16, 2023
• Study Completion: June 16, 2023
• Last Updated: May 23, 2025

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)