Posterior Vitreous DetachmentNCT02290795
Vitreopapillary Interface and Optic Disc Morphology
An observational study of Posterior Vitreous Detachment and Vitreomacular Traction, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Posterior Vitreous Detachment, Vitreomacular Traction, Glaucoma
- What is being tested?
- OCT imaging/HRT imaging
- How many people
- 350 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2014to Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- willingness to sign informed consent, aged over 18y, glaucoma/trabeculectomy scheduled/Ocriplasmin scheduled/healthy
Who cannot join
- medical history of vitrectomy/diabetes/Retinal Vessel Occlusion
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals Leuven
Leuven, 3000
Ingeborg Stalmans, MD PhD, 016 332372, ingeborg.stalmans@uzleuven.be
Koen Willekens, MD, 016 332372, koen.willekens@uzleuven.be
About this study
Official title: Vitreopapillary Traction and Optic Disc Morphology in Healthy Subjects, Vitreomacular Traction Patients and Glaucoma Patients
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.
Read the 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.
- Being tested
- OCT imaging/HRT imaging
- Keywords
- Vitreopapillary traction
- Medical subject headings
- Vitreous Detachment, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT imaging/HRT imagingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| healthy subjects | Healthy subjects (not diagnosed with any eye disease affecting the vitreous or optic nerve head). Receives: Other: OCT imaging/HRT imaging | |
| Glaucoma patients | Glaucoma patients visiting the glaucoma consultation. Receives: Other: OCT imaging/HRT imaging | |
| Patients scheduled for trabeculectomy | Glaucoma patients scheduled for filtering surgery (=trabeculectomy) Receives: Other: OCT imaging/HRT imaging | |
| Vitreomacular traction patients | Patients with symptomative vitreomacular adhesion scheduled for treatment with Ocriplasmin Receives: Other: OCT imaging/HRT imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of VPT in glaucoma patients
Percentage of patients diagnosed with glaucoma who have Vitreopapillary traction.
Measured: 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)
Measured: 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)
Measured: 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
To investigate whether patients with VPT have significantly more chance of ONH hemorrhages than subjects without VPT. Cross-sectional analysis so 1 visit per patient between 11/2014 and 4/2016.
Measured: From inclusion up to 17 months
Proportion of patients with focal visual field defect that have corresponding focal VPT
To investigate whether a firm vitreous attachment and traction to a certain part of the ONH (focal rim thickness, focal RNFL thickness) could play a role in the formation of anatomically linked visual field defects. Cross-sectional analysis so 1 visit per patient between 11/2014 and 4/2016. Part two of the analysis on patients scheduled for trabeculectomy who will have a baseline visit up until 8 weeks before the surgery and 4 post operative visits (day 1, week 1, 2 and 4)
Measured: From inclusion up to 17 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionApr 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Posterior Vitreous DetachmentStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ingeborg Stalmans, MD PhD, Principal investigator, Dpt. Ophthalmology, University Hospitals Leuven, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02290795
- Sponsor's protocol ID
- VPI study
- Status last verified
- Jul 2024
- First submitted
- 29 Oct 2014
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24880904Wisotsky 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.
PubMed 9683164Hwang 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.
PubMed 24171792Willekens 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.
PubMed 30280516
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitreopapillary Traction and Optic Disc Morphology in Healthy Subjects, Vitreomacular Traction Patients and Glaucoma Patients
- ClinicalTrials.gov ID
- NCT02290795
- Acronym / sponsor ID
- VPI study
- Keywords
- Vitreopapillary traction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 14 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| healthy subjects | – | Other: OCT imaging/HRT imagingHealthy subjects (not diagnosed with any eye disease affecting the vitreous or optic nerve head). |
| Glaucoma patients | – | Other: OCT imaging/HRT imagingGlaucoma patients visiting the glaucoma consultation. |
| Patients scheduled for trabeculectomy | – | Other: OCT imaging/HRT imagingGlaucoma patients scheduled for filtering surgery (=trabeculectomy) |
| Vitreomacular traction patients | – | Other: OCT imaging/HRT imagingPatients with symptomative vitreomacular adhesion scheduled for treatment with Ocriplasmin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- willingness to sign informed consent, aged over 18y, glaucoma/trabeculectomy scheduled/Ocriplasmin scheduled/healthy
Key exclusion criteria (1 listed)
- medical history of vitrectomy/diabetes/Retinal Vessel Occlusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCT imaging/HRT imagingStandard 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. | Other | Glaucoma patients, Patients scheduled for trabeculectomy, Vitreomacular traction patients, healthy subjects |
Primary outcome
Prevalence of VPT in glaucoma patients
Time frame: From inclusion up to 17 months
Percentage of patients diagnosed with glaucoma who have Vitreopapillary traction.
Change in VPT following trabeculectomy
Time frame: From inclusion up to 17 months with an average follow up of 8 weeks per subject
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)
Change in VPT following ocriplasmin
Time frame: From inclusion up to 17 months with an average follow up of 8 weeks per subject
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)
2 secondary outcomes
Proportion of patients with VPT that present with optic nerve head hemorrhage
Time frame: From inclusion up to 17 months
Proportion of patients with focal visual field defect that have corresponding focal VPT
Time frame: From inclusion up to 17 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Background: PubMed 24880904Kim 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.
- Background: PubMed 9683164Wisotsky 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.
- Background: PubMed 24171792Hwang 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.
- Derived from this study: PubMed 30280516Willekens 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ingeborg Stalmans, MD PhD principal investigator
Dpt. Ophthalmology, University Hospitals Leuven, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Posterior Vitreous Detachment and Vitreomacular Traction, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ingeborg Stalmans, MD, PhD (016 33 23 70, ingeborg.stalmans@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of VPT in glaucoma patients (time frame: From inclusion up to 17 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02290795, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024.