Vitreopapillary Interface and Optic Disc Morphology

NCT02290795 | Recruiting

• 1 other identifier: VPI study
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Posterior Vitreous Detachment; Vitreomacular Traction; Glaucoma; Vitreopapillary Traction

Keywords

Vitreopapillary traction

Outcome Measures

Primary Outcomes (3)

• Prevalence of VPT in glaucoma patients

  Percentage of patients diagnosed with glaucoma who have Vitreopapillary traction.

  From inclusion up to 17 months

• Change in VPT following trabeculectomy

  To investigate whether the sudden decrease in intraocular pressure following trabeculectomy has a significant effect on ONH morphology (mean retinal nerve fiber layer (mRNFL) thickness, cup volume, rim thickness, cup/disc ratio) caused by change in VPT. Patients scheduled for trabeculectomy will have a baseline visit up until 8 weeks before the surgery and 4 post operative visits (day 1, week 1, 2 and 4)

  From inclusion up to 17 months with an average follow up of 8 weeks per subject

• Change in VPT following ocriplasmin

  To investigate whether the use of Ocriplasmin has a significant effect on ONH morphology (mRNFL thickness, cup volume, rim thickness, cup/disc ratio) caused by change in VPT. Patients scheduled for Ocriplasmin treatment will have a baseline visit 1 week before the surgery and 2 post operative visits (day 1, week 4)

  From inclusion up to 17 months with an average follow up of 8 weeks per subject

Secondary Outcomes (2)

• Proportion of patients with VPT that present with optic nerve head hemorrhage

  From inclusion up to 17 months

• Proportion of patients with focal visual field defect that have corresponding focal VPT

  From inclusion up to 17 months

Study Arms (4)

healthy subjects

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

Other: OCT imaging/HRT imaging

Glaucoma patients

Glaucoma patients visiting the glaucoma consultation.

Other: OCT imaging/HRT imaging

Patients scheduled for trabeculectomy

Glaucoma patients scheduled for filtering surgery (=trabeculectomy)

Other: OCT imaging/HRT imaging

Vitreomacular traction patients

Patients with symptomative vitreomacular adhesion scheduled for treatment with Ocriplasmin

Other: OCT imaging/HRT imaging

Interventions

OCT imaging/HRT imaging 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; Patients scheduled for trabeculectomy; Vitreomacular traction patients; healthy subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population consists of patients visiting either the glaucoma consultation or the vitreo-retinal disease consultation (depending on study group recruitment). Healthy controls will be recruited from subjects accompanying these patients.

You may qualify if:

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

You may not qualify if:

• medical history of vitrectomy/diabetes/Retinal Vessel Occlusion

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

RECRUITING

Related Publications (4)

• 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.

  PMID: 24880904 BACKGROUND

• 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.

  PMID: 9683164 BACKGROUND

• 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.

  PMID: 24171792 BACKGROUND

• 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.

  PMID: 30280516 DERIVED

MeSH Terms

Conditions

Vitreous Detachment; Glaucoma

Condition Hierarchy (Ancestors)

Eye Diseases; Ocular Hypertension

Study Officials

• Ingeborg Stalmans, MD PhD

  Dpt. Ophthalmology, University Hospitals Leuven, Belgium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ingeborg Stalmans, MD, PhD

CONTACT

016 33 23 70; ingeborg.stalmans@uzleuven.be

Koen Willekens, MD

CONTACT

016 33 23 70; koen.willekens@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2014
• First Posted: November 14, 2014
• Study Start: November 1, 2014
• Primary Completion: April 1, 2025
• Study Completion: August 1, 2025
• Last Updated: July 10, 2024

Record last verified: 2024-07

Locations

BE (1)