Vitreopapillary Interface and Optic Disc Morphology

NCT ID: NCT02290795

Last Updated: 2024-07-10

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 350 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2025-08-31

Brief Summary

The vitreous fills the posterior chamber of the eye and is firmly attached, at the posterior pole, to the macula and the optic nerve head (ONH). With formation of a stepwise posterior vitreous detachment (PVD) exerted tractional forces could influence retinal functioning. Especially in patients with glaucoma the influence of vitreous traction to the ONH could mask progression, interfere with current imaging techniques and even be a cause of ONH hemorrhages. Therefore the aim of this study is to investigate whether vitreopapillary traction has a significant effect on diagnosis and follow up of glaucoma patients.

Detailed Description

The vitreous body fills the posterior chamber of the eye and consists mainly of water. It is kept organized into a gel like structure by numerous collagen fibrils and makes contact with the surrounding retina. This interplay known as the vitreo-retinal interface of the human eye is a complex organization of bridging molecules anchoring the vitreous to the internal limiting membrane. With ageing, the vitreous gel undergoes liquefaction accompanied by progressive weakening of the adhesions at the vitreo-retinal interface resulting in a stepwise process of adhesion release. Since the most firm attachments in the posterior pole are situated at the macular and papillary region, tractional forces exerted during vitreous separation could influence retinal functioning.

Up until now researchers have been looking primarily at the influence of vitreous traction to the macular region of the nerve fiber layer.This research has led to the insight that vitreo-macular traction can result in macular hole formation, and that patients with this condition may benefit from vitreolysis induced by surgery (vitrectomy) or intravitreal injection of ocriplasmin.

More recent reports have focused on the influence of the vitreous on the morphology of the optic disc, showing that VPT altered optic disc architecture, increased average and temporal retinal nerve fiber layer thickness and was associated with more pronounced visual field defects. This could be important as very sensitive scans and diagnostic algorithms were developed for staging and follow up of glaucoma patients' optic nerve head, which could be influenced by the patients' vitreopapillar interface. As the status of this interface changes over time, this could lead to confusion and misinterpretation of the optic disc diagnostic scans.

Besides the diagnostic challenges induced by the vitreopapillar interaction, this interface may also be of pathogenetic relevance in glaucoma. Indeed, the optic disc represents the collection of all ganglion cell axons, and glaucoma is caused by a degeneration of ganglion cells. Some authors have already suggested that vitreopapillary traction (VPT) could play a role in the pathogenesis of optic nerve head hemorrhages, which are regarded as an important risk factor for glaucoma progression. Moreover, one could hypothesize that VPT can cause stress to the ganglion cell axons and therefore contribute more directly to ganglion cell degeneration.

Accordingly, this study aims at investigating the effect of VPT on the ultra-structural level of the optic disc. A possible structure-function relation will be investigated with the help of central visual field tests and focal retinal nerve fiber layer thickness assessment. With increasing knowledge and imaging of VPT, possibly a VPT-staging algorithm can be developed and VPT risk factors defined. Finally, this project may have a therapeutic impact, since it will shed light on the question whether (surgically or chemically) induced vitreolysis might be beneficial in some glaucoma patients with VPT.

Conditions

Posterior Vitreous Detachment; Vitreomacular Traction; Glaucoma; Vitreopapillary Traction

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

healthy subjects

Healthy subjects (not diagnosed with any eye disease affecting the vitreous or optic nerve head).

OCT imaging/HRT imaging

Intervention Type: OTHER

Standard follow up protocol with Optical coherence Tomography (OCT) imaging and Heidelberg Retinal Tomograph (HRT) imaging for glaucoma patients and patients scheduled for Ocriplasmin treatment In case of healthy controls the same investigations will be performed.

Glaucoma patients

Glaucoma patients visiting the glaucoma consultation.

OCT imaging/HRT imaging

Intervention Type: OTHER

Standard follow up protocol with Optical coherence Tomography (OCT) imaging and Heidelberg Retinal Tomograph (HRT) imaging for glaucoma patients and patients scheduled for Ocriplasmin treatment In case of healthy controls the same investigations will be performed.

Patients scheduled for trabeculectomy

Glaucoma patients scheduled for filtering surgery (=trabeculectomy)

OCT imaging/HRT imaging

Intervention Type: OTHER

Standard follow up protocol with Optical coherence Tomography (OCT) imaging and Heidelberg Retinal Tomograph (HRT) imaging for glaucoma patients and patients scheduled for Ocriplasmin treatment In case of healthy controls the same investigations will be performed.

Vitreomacular traction patients

Patients with symptomative vitreomacular adhesion scheduled for treatment with Ocriplasmin

OCT imaging/HRT imaging

Intervention Type: OTHER

Standard follow up protocol with Optical coherence Tomography (OCT) imaging and Heidelberg Retinal Tomograph (HRT) imaging for glaucoma patients and patients scheduled for Ocriplasmin treatment In case of healthy controls the same investigations will be performed.

Interventions

OCT imaging/HRT imaging

Standard follow up protocol with Optical coherence Tomography (OCT) imaging and Heidelberg Retinal Tomograph (HRT) imaging for glaucoma patients and patients scheduled for Ocriplasmin treatment In case of healthy controls the same investigations will be performed.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• willingness to sign informed consent, aged over 18y, glaucoma/trabeculectomy scheduled/Ocriplasmin scheduled/healthy

Exclusion Criteria

• medical history of vitrectomy/diabetes/Retinal Vessel Occlusion

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ingeborg Stalmans, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Dpt. Ophthalmology, University Hospitals Leuven, Belgium

Locations

University Hospitals Leuven

Leuven, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Ingeborg Stalmans, MD, PhD

Role: CONTACT

ingeborg.stalmans@uzleuven.be

016 33 23 70

Koen Willekens, MD

Role: CONTACT

koen.willekens@uzleuven.be

016 33 23 70

Facility Contacts

Ingeborg Stalmans, MD PhD

Role: primary

ingeborg.stalmans@uzleuven.be

016 332372

Koen Willekens, MD

Role: backup

koen.willekens@uzleuven.be

016 332372

References

Kim YW, Jeoung JW, Yu HG. Vitreopapillary traction in eyes with idiopathic epiretinal membrane: a spectral-domain optical coherence tomography study. Ophthalmology. 2014 Oct;121(10):1976-82. doi: 10.1016/j.ophtha.2014.04.011. Epub 2014 May 29.

Reference Type: BACKGROUND

PMID: 24880904 (View on PubMed)

Wisotsky BJ, Magat-Gordon CB, Puklin JE. Vitreopapillary traction as a cause of elevated optic nerve head. Am J Ophthalmol. 1998 Jul;126(1):137-9. doi: 10.1016/s0002-9394(98)00080-4.

Reference Type: BACKGROUND

PMID: 9683164 (View on PubMed)

Hwang YH, Kim YY. Peripapillary retinal nerve fiber layer thickening associated with vitreopapillary traction. Semin Ophthalmol. 2015 Mar;30(2):136-8. doi: 10.3109/08820538.2013.833257. Epub 2013 Oct 30.

Reference Type: BACKGROUND

PMID: 24171792 (View on PubMed)

Willekens K, Abegao Pinto L, Lemmens S, Bataillie S, Somers A, Vandewalle E, Stalmans P, Stalmans I. The vitreopapillary interface in healthy and glaucoma: posterior vitreous detachment in the vitreopapillary interface study. Acta Ophthalmol. 2018 Sep;96(6):573-581. doi: 10.1111/aos.13818. Epub 2018 Oct 2.

Reference Type: DERIVED

PMID: 30280516 (View on PubMed)

Other Identifiers

VPI study

Identifier Type: -

Identifier Source: org_study_id