Vitreopapillary Interface and Optic Disc Morphology
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
willingness to sign informed consent, aged over 18y, glaucoma/trabeculectomy scheduled/Ocriplasmin scheduled/healthy
Disqualifiers
medical history of vitrectomy/diabetes/Retinal Vessel Occlusion
Trial 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
OCT imaging/HRT imaging
Other interventionStandard 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.
Treatment groups
350 Participants
are divided into 4 treatment groupsGroup A: healthy subjects1 intervention
Group B: Glaucoma patients1 intervention
Group C: Patients scheduled for trabeculectomy1 intervention
Group D: Vitreomacular traction patients1 intervention
Trial outcomes
Primary outcomes
1
Prevalence of VPT in glaucoma patients
Percentage of patients diagnosed with glaucoma who have Vitreopapillary traction.
Time frame
From inclusion up to 17 months2
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)
Time frame
From inclusion up to 17 months with an average follow up of 8 weeks per subject3
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)
Time frame
From inclusion up to 17 months with an average follow up of 8 weeks per subjectSecondary outcomes
1
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.
Time frame
From inclusion up to 17 months2
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)
Time frame
From inclusion up to 17 monthsSponsors and contacts
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Source ClinicalTrials.gov